MAUDEScope — deduplicated MAUDE findings by product codehttps://10xand.com/api/maude/v0/pulse.xml2026-09-15T00:00:00ZMAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event. This feed carries the 50 most recent of 175 findings across the catalog; the full set is in index.json and the per-code slices.MAUDEScope pipelineEOB 2026Q3: reports above threshold (part-quarter)https://10xand.com/feed/maude/spike/EOB/2026Q32026-09-30T00:00:00Z2026-09-15T00:00:00Z2026Q3: 798 reports received under product code EOB, above the threshold of 646.0 set by the preceding eight quarters. After deduplication the quarter still stands out: 703 estimated distinct events. This quarter is INCOMPLETE: openFDA's file was cut inside it, so the count covers part of a quarter. It cleared the threshold on partial data, and it cannot be compared like-for-like with the complete quarters before it. No FDA device recall for this product code was initiated in the quarter or the two before it. The quarter is unannotated, which is not the same as having no cause. MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.EOB 2026Q2: reports above thresholdhttps://10xand.com/feed/maude/spike/EOB/2026Q22026-06-30T00:00:00Z2026-09-15T00:00:00Z2026Q2: 960 reports received under product code EOB, above the threshold of 522.0 set by the preceding eight quarters. After deduplication the quarter still stands out: 894 estimated distinct events. No FDA device recall for this product code was initiated in the quarter or the two before it. The quarter is unannotated, which is not the same as having no cause. MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO 2026Q2: reports above thresholdhttps://10xand.com/feed/maude/spike/DQO/2026Q22026-06-30T00:00:00Z2026-09-15T00:00:00Z2026Q2: 234 reports received under product code DQO, above the threshold of 202.5 set by the preceding eight quarters. After deduplication the quarter still stands out: 170 estimated distinct events. FDA device recall(s) initiated for this product code in the quarter or the two before it: Z-1934-2026, Z-1935-2026, Z-1936-2026, Z-1823-2026, Z-1778-2026, Z-1856-2026, Z-1857-2026, Z-1858-2026, Z-1859-2026, Z-1860-2026, Z-1861-2026, Z-1862-2026, Z-1863-2026, Z-1864-2026, Z-1865-2026, Z-1866-2026, Z-1867-2026, Z-1868-2026, Z-1869-2026, Z-1870-2026, Z-1871-2026, Z-1872-2026, Z-1873-2026, Z-1874-2026, Z-1875-2026. MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1936-2026https://10xand.com/feed/maude/recall/DQO/Z-1936-20262026-04-02T00:00:00Z2026-09-15T00:00:00ZRecall Z-1936-2026 was initiated 2026-04-02 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98682 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1935-2026https://10xand.com/feed/maude/recall/DQO/Z-1935-20262026-04-02T00:00:00Z2026-09-15T00:00:00ZRecall Z-1935-2026 was initiated 2026-04-02 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98682 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1934-2026https://10xand.com/feed/maude/recall/DQO/Z-1934-20262026-04-02T00:00:00Z2026-09-15T00:00:00ZRecall Z-1934-2026 was initiated 2026-04-02 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98682 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.EOB 2026Q1: reports above thresholdhttps://10xand.com/feed/maude/spike/EOB/2026Q12026-03-31T00:00:00Z2026-09-15T00:00:00Z2026Q1: 461 reports received under product code EOB, above the threshold of 407.5 set by the preceding eight quarters. After deduplication the quarter still stands out: 442 estimated distinct events. No FDA device recall for this product code was initiated in the quarter or the two before it. The quarter is unannotated, which is not the same as having no cause. MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO 2026Q1: reports above thresholdhttps://10xand.com/feed/maude/spike/DQO/2026Q12026-03-31T00:00:00Z2026-09-15T00:00:00Z2026Q1: 211 reports received under product code DQO, above the threshold of 203.5 set by the preceding eight quarters. After deduplication the quarter still stands out: 140 estimated distinct events. FDA device recall(s) initiated for this product code in the quarter or the two before it: Z-1823-2026, Z-1778-2026, Z-1856-2026, Z-1857-2026, Z-1858-2026, Z-1859-2026, Z-1860-2026, Z-1861-2026, Z-1862-2026, Z-1863-2026, Z-1864-2026, Z-1865-2026, Z-1866-2026, Z-1867-2026, Z-1868-2026, Z-1869-2026, Z-1870-2026, Z-1871-2026, Z-1872-2026, Z-1873-2026, Z-1874-2026, Z-1875-2026. MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1823-2026https://10xand.com/feed/maude/recall/DQO/Z-1823-20262026-03-23T00:00:00Z2026-09-15T00:00:00ZRecall Z-1823-2026 was initiated 2026-03-23 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Device Design. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98619 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1778-2026https://10xand.com/feed/maude/recall/DQO/Z-1778-20262026-03-05T00:00:00Z2026-09-15T00:00:00ZRecall Z-1778-2026 was initiated 2026-03-05 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Incorrect or no expiration date. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98495 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1875-2026https://10xand.com/feed/maude/recall/DQO/Z-1875-20262026-03-03T00:00:00Z2026-09-15T00:00:00ZRecall Z-1875-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1874-2026https://10xand.com/feed/maude/recall/DQO/Z-1874-20262026-03-03T00:00:00Z2026-09-15T00:00:00ZRecall Z-1874-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1873-2026https://10xand.com/feed/maude/recall/DQO/Z-1873-20262026-03-03T00:00:00Z2026-09-15T00:00:00ZRecall Z-1873-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1872-2026https://10xand.com/feed/maude/recall/DQO/Z-1872-20262026-03-03T00:00:00Z2026-09-15T00:00:00ZRecall Z-1872-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1871-2026https://10xand.com/feed/maude/recall/DQO/Z-1871-20262026-03-03T00:00:00Z2026-09-15T00:00:00ZRecall Z-1871-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1870-2026https://10xand.com/feed/maude/recall/DQO/Z-1870-20262026-03-03T00:00:00Z2026-09-15T00:00:00ZRecall Z-1870-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1869-2026https://10xand.com/feed/maude/recall/DQO/Z-1869-20262026-03-03T00:00:00Z2026-09-15T00:00:00ZRecall Z-1869-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1868-2026https://10xand.com/feed/maude/recall/DQO/Z-1868-20262026-03-03T00:00:00Z2026-09-15T00:00:00ZRecall Z-1868-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1867-2026https://10xand.com/feed/maude/recall/DQO/Z-1867-20262026-03-03T00:00:00Z2026-09-15T00:00:00ZRecall Z-1867-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1866-2026https://10xand.com/feed/maude/recall/DQO/Z-1866-20262026-03-03T00:00:00Z2026-09-15T00:00:00ZRecall Z-1866-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1865-2026https://10xand.com/feed/maude/recall/DQO/Z-1865-20262026-03-03T00:00:00Z2026-09-15T00:00:00ZRecall Z-1865-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1864-2026https://10xand.com/feed/maude/recall/DQO/Z-1864-20262026-03-03T00:00:00Z2026-09-15T00:00:00ZRecall Z-1864-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1863-2026https://10xand.com/feed/maude/recall/DQO/Z-1863-20262026-03-03T00:00:00Z2026-09-15T00:00:00ZRecall Z-1863-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1862-2026https://10xand.com/feed/maude/recall/DQO/Z-1862-20262026-03-03T00:00:00Z2026-09-15T00:00:00ZRecall Z-1862-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1861-2026https://10xand.com/feed/maude/recall/DQO/Z-1861-20262026-03-03T00:00:00Z2026-09-15T00:00:00ZRecall Z-1861-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1860-2026https://10xand.com/feed/maude/recall/DQO/Z-1860-20262026-03-03T00:00:00Z2026-09-15T00:00:00ZRecall Z-1860-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1859-2026https://10xand.com/feed/maude/recall/DQO/Z-1859-20262026-03-03T00:00:00Z2026-09-15T00:00:00ZRecall Z-1859-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1858-2026https://10xand.com/feed/maude/recall/DQO/Z-1858-20262026-03-03T00:00:00Z2026-09-15T00:00:00ZRecall Z-1858-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1857-2026https://10xand.com/feed/maude/recall/DQO/Z-1857-20262026-03-03T00:00:00Z2026-09-15T00:00:00ZRecall Z-1857-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1856-2026https://10xand.com/feed/maude/recall/DQO/Z-1856-20262026-03-03T00:00:00Z2026-09-15T00:00:00ZRecall Z-1856-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.EOB 2025Q4: reports above thresholdhttps://10xand.com/feed/maude/spike/EOB/2025Q42025-12-31T00:00:00Z2026-09-15T00:00:00Z2025Q4: 481 reports received under product code EOB, above the threshold of 398.0 set by the preceding eight quarters. After deduplication the quarter still stands out: 440 estimated distinct events. No FDA device recall for this product code was initiated in the quarter or the two before it. The quarter is unannotated, which is not the same as having no cause. MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO 2025Q4: reports above threshold — does not survive deduplicationhttps://10xand.com/feed/maude/spike/DQO/2025Q42025-12-31T00:00:00Z2026-09-15T00:00:00Z2025Q4: 203 reports received under product code DQO, above the threshold of 199.0 set by the preceding eight quarters — but the quarter does NOT stand out after deduplication (120 estimated distinct events). On this method that is a reporting pattern rather than a change in the number of events. FDA device recall(s) initiated for this product code in the quarter or the two before it: Z-1902-2025. MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1902-2025https://10xand.com/feed/maude/recall/DQO/Z-1902-20252025-05-15T00:00:00Z2026-09-15T00:00:00ZRecall Z-1902-2025 was initiated 2025-05-15 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Process change control. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=96848 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO 2024Q4: reports above threshold — does not survive deduplicationhttps://10xand.com/feed/maude/spike/DQO/2024Q42024-12-31T00:00:00Z2026-09-15T00:00:00Z2024Q4: 147 reports received under product code DQO, above the threshold of 143.5 set by the preceding eight quarters — but the quarter does NOT stand out after deduplication (114 estimated distinct events). On this method that is a reporting pattern rather than a change in the number of events. FDA device recall(s) initiated for this product code in the quarter or the two before it: Z-2453-2024, Z-2454-2024, Z-1904-2024. MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO 2024Q3: reports above thresholdhttps://10xand.com/feed/maude/spike/DQO/2024Q32024-09-30T00:00:00Z2026-09-15T00:00:00Z2024Q3: 140 reports received under product code DQO, above the threshold of 125.5 set by the preceding eight quarters. After deduplication the quarter still stands out: 119 estimated distinct events. FDA device recall(s) initiated for this product code in the quarter or the two before it: Z-2453-2024, Z-2454-2024, Z-1904-2024, Z-1638-2024, Z-1639-2024, Z-1640-2024, Z-1641-2024, Z-1642-2024, Z-1643-2024, Z-1644-2024, Z-1645-2024, Z-1646-2024, Z-1647-2024, Z-1648-2024, Z-1649-2024, Z-1650-2024, Z-1651-2024, Z-1652-2024, Z-1653-2024, Z-1654-2024, Z-1655-2024, Z-1656-2024, Z-1657-2024, Z-1658-2024, Z-1659-2024, Z-1660-2024, Z-1661-2024, Z-1662-2024, Z-1663-2024, Z-1664-2024, Z-1665-2024, Z-1666-2024, Z-1667-2024, Z-1668-2024, Z-1669-2024, Z-1670-2024, Z-1671-2024, Z-1672-2024, Z-1673-2024, Z-1674-2024, Z-1675-2024, Z-1676-2024, Z-1677-2024, Z-1678-2024, Z-1679-2024, Z-1680-2024, Z-1681-2024, Z-1682-2024, Z-1683-2024, Z-1684-2024, Z-1685-2024. MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.LRC 2024Q2: reports above threshold — does not survive deduplicationhttps://10xand.com/feed/maude/spike/LRC/2024Q22024-06-30T00:00:00Z2026-09-15T00:00:00Z2024Q2: 26 reports received under product code LRC, above the threshold of 10.0 set by the preceding eight quarters — but the quarter does NOT stand out after deduplication (10 estimated distinct events). On this method that is a reporting pattern rather than a change in the number of events. FDA device recall(s) initiated for this product code in the quarter or the two before it: Z-1474-2024, Z-0574-2024. MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-2454-2024https://10xand.com/feed/maude/recall/DQO/Z-2454-20242024-06-18T00:00:00Z2026-09-15T00:00:00ZRecall Z-2454-2024 was initiated 2024-06-18 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Packaging change control. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94903 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-2453-2024https://10xand.com/feed/maude/recall/DQO/Z-2453-20242024-06-18T00:00:00Z2026-09-15T00:00:00ZRecall Z-2453-2024 was initiated 2024-06-18 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Packaging change control. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94903 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1904-2024https://10xand.com/feed/maude/recall/DQO/Z-1904-20242024-04-23T00:00:00Z2026-09-15T00:00:00ZRecall Z-1904-2024 was initiated 2024-04-23 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Process design. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94437 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO 2024Q1: reports above thresholdhttps://10xand.com/feed/maude/spike/DQO/2024Q12024-03-31T00:00:00Z2026-09-15T00:00:00Z2024Q1: 114 reports received under product code DQO, above the threshold of 113.5 set by the preceding eight quarters. After deduplication the quarter still stands out: 102 estimated distinct events. FDA device recall(s) initiated for this product code in the quarter or the two before it: Z-1638-2024, Z-1639-2024, Z-1640-2024, Z-1641-2024, Z-1642-2024, Z-1643-2024, Z-1644-2024, Z-1645-2024, Z-1646-2024, Z-1647-2024, Z-1648-2024, Z-1649-2024, Z-1650-2024, Z-1651-2024, Z-1652-2024, Z-1653-2024, Z-1654-2024, Z-1655-2024, Z-1656-2024, Z-1657-2024, Z-1658-2024, Z-1659-2024, Z-1660-2024, Z-1661-2024, Z-1662-2024, Z-1663-2024, Z-1664-2024, Z-1665-2024, Z-1666-2024, Z-1667-2024, Z-1668-2024, Z-1669-2024, Z-1670-2024, Z-1671-2024, Z-1672-2024, Z-1673-2024, Z-1674-2024, Z-1675-2024, Z-1676-2024, Z-1677-2024, Z-1678-2024, Z-1679-2024, Z-1680-2024, Z-1681-2024, Z-1682-2024, Z-1683-2024, Z-1684-2024, Z-1685-2024, Z-1084-2024, Z-0286-2024. MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1685-2024https://10xand.com/feed/maude/recall/DQO/Z-1685-20242024-03-21T00:00:00Z2026-09-15T00:00:00ZRecall Z-1685-2024 was initiated 2024-03-21 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94240 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1684-2024https://10xand.com/feed/maude/recall/DQO/Z-1684-20242024-03-21T00:00:00Z2026-09-15T00:00:00ZRecall Z-1684-2024 was initiated 2024-03-21 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94240 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1683-2024https://10xand.com/feed/maude/recall/DQO/Z-1683-20242024-03-21T00:00:00Z2026-09-15T00:00:00ZRecall Z-1683-2024 was initiated 2024-03-21 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94240 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1682-2024https://10xand.com/feed/maude/recall/DQO/Z-1682-20242024-03-21T00:00:00Z2026-09-15T00:00:00ZRecall Z-1682-2024 was initiated 2024-03-21 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94240 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1681-2024https://10xand.com/feed/maude/recall/DQO/Z-1681-20242024-03-21T00:00:00Z2026-09-15T00:00:00ZRecall Z-1681-2024 was initiated 2024-03-21 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94240 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1680-2024https://10xand.com/feed/maude/recall/DQO/Z-1680-20242024-03-21T00:00:00Z2026-09-15T00:00:00ZRecall Z-1680-2024 was initiated 2024-03-21 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94240 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1679-2024https://10xand.com/feed/maude/recall/DQO/Z-1679-20242024-03-21T00:00:00Z2026-09-15T00:00:00ZRecall Z-1679-2024 was initiated 2024-03-21 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94240 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1678-2024https://10xand.com/feed/maude/recall/DQO/Z-1678-20242024-03-21T00:00:00Z2026-09-15T00:00:00ZRecall Z-1678-2024 was initiated 2024-03-21 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94240 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1677-2024https://10xand.com/feed/maude/recall/DQO/Z-1677-20242024-03-21T00:00:00Z2026-09-15T00:00:00ZRecall Z-1677-2024 was initiated 2024-03-21 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94240 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.DQO: FDA device recall Z-1676-2024https://10xand.com/feed/maude/recall/DQO/Z-1676-20242024-03-21T00:00:00Z2026-09-15T00:00:00ZRecall Z-1676-2024 was initiated 2024-03-21 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94240 MAUDE contains counts, not rates. An MDR is a report, not a finding: FDA does not verify reports and a report does not establish that a device caused the event.