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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

4 linked reportsInjury 2Malfunction 2
13462019-01: 0 reports for this device; peer average 1.38/device2019-02: 0 reports for this device; peer average 2.07/device2019-03: 0 reports for this device; peer average 1.86/device2019-04: 0 reports for this device; peer average 1.8/device2019-05: 0 reports for this device; peer average 2.52/device2019-06: 0 reports for this device; peer average 1.81/device2019-07: 0 reports for this device; peer average 2.87/device2019-08: 0 reports for this device; peer average 2.39/device2019-09: 0 reports for this device; peer average 2.16/device2019-10: 0 reports for this device; peer average 2.25/device2019-11: 0 reports for this device; peer average 1.76/device2019-12: 0 reports for this device; peer average 1.96/device2020-01: 0 reports for this device; peer average 2.51/device2020-02: 0 reports for this device; peer average 2.24/device2020-03: 0 reports for this device; peer average 2.38/device2020-04: 0 reports for this device; peer average 1.71/device2020-05: 0 reports for this device; peer average 2.13/device2020-06: 0 reports for this device; peer average 2.92/device2020-07: 0 reports for this device; peer average 1.97/device2020-08: 0 reports for this device; peer average 2.47/device2020-09: 0 reports for this device; peer average 2.13/device2020-10: 0 reports for this device; peer average 2.37/device2020-11: 0 reports for this device; peer average 2.59/device2020-12: 0 reports for this device; peer average 2.07/device2021-01: 0 reports for this device; peer average 2.09/device2021-02: 0 reports for this device; peer average 2.25/device2021-03: 0 reports for this device; peer average 2.07/device2021-04: 0 reports for this device; peer average 3.48/device2021-05: 0 reports for this device; peer average 2.14/device2021-06: 1 reports for this device; peer average 2.22/device2021-07: 0 reports for this device; peer average 2.2/device2021-08: 0 reports for this device; peer average 2.39/device2021-09: 0 reports for this device; peer average 3.76/device2021-10: 0 reports for this device; peer average 3.29/device2021-11: 1 reports for this device; peer average 3.34/device2021-12: 0 reports for this device; peer average 4.77/device2022-01: 0 reports for this device; peer average 2.43/device2022-02: 0 reports for this device; peer average 2.09/device2022-03: 0 reports for this device; peer average 1.88/device2022-04: 0 reports for this device; peer average 1.84/device2022-05: 0 reports for this device; peer average 1.85/device2022-06: 0 reports for this device; peer average 2.07/device2022-07: 0 reports for this device; peer average 1.95/device2022-08: 1 reports for this device; peer average 2.16/device2022-09: 0 reports for this device; peer average 1.82/device2022-10: 0 reports for this device; peer average 2.64/device2022-11: 0 reports for this device; peer average 2.04/device2022-12: 0 reports for this device; peer average 2.33/device2023-01: 0 reports for this device; peer average 1.96/device2023-02: 0 reports for this device; peer average 2.4/device2023-03: 0 reports for this device; peer average 1.91/device2023-04: 0 reports for this device; peer average 2.09/device2023-05: 0 reports for this device; peer average 1.95/device2023-06: 0 reports for this device; peer average 2.06/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 2.32/device2023-09: 0 reports for this device; peer average 1.98/device2023-10: 0 reports for this device; peer average 2.02/device2023-11: 0 reports for this device; peer average 5.85/device2023-12: 0 reports for this device; peer average 2.78/device2024-01: 0 reports for this device; peer average 1.83/device2024-02: 0 reports for this device; peer average 1.93/device2024-03: 0 reports for this device; peer average 1.88/device2024-04: 0 reports for this device; peer average 2.01/device2024-05: 0 reports for this device; peer average 2.03/device2024-06: 0 reports for this device; peer average 1.82/device2024-07: 0 reports for this device; peer average 2.17/device2024-08: 0 reports for this device; peer average 1.84/device2024-09: 0 reports for this device; peer average 2.21/device2024-10: 0 reports for this device; peer average 2.08/device2024-11: 0 reports for this device; peer average 2.31/device2024-12: 0 reports for this device; peer average 2.14/device2025-01: 0 reports for this device; peer average 1.75/device2025-02: 0 reports for this device; peer average 2.61/device2025-03: 0 reports for this device; peer average 2.57/device2025-04: 0 reports for this device; peer average 2.4/device2025-05: 0 reports for this device; peer average 2.64/device2025-06: 0 reports for this device; peer average 2.82/device2025-07: 0 reports for this device; peer average 2.35/device2025-08: 0 reports for this device; peer average 1.95/device2025-09: 1 reports for this device; peer average 1.86/device2025-10: 0 reports for this device; peer average 2.57/device2025-11: 0 reports for this device; peer average 2.5/device2025-12: 0 reports for this device; peer average 2.67/device2026-01: 0 reports for this device; peer average 2.19/device2026-02: 0 reports for this device; peer average 2.52/device2026-03: 0 reports for this device; peer average 2.57/device2026-04: 0 reports for this device; peer average 1.95/device2026-05: 0 reports for this device; peer average 2.21/device2026-06: 0 reports for this device; peer average 1.92/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.38
2019-0202.07
2019-0301.86
2019-0401.8
2019-0502.52
2019-0601.81
2019-0702.87
2019-0802.39
2019-0902.16
2019-1002.25
2019-1101.76
2019-1201.96
2020-0102.51
2020-0202.24
2020-0302.38
2020-0401.71
2020-0502.13
2020-0602.92
2020-0701.97
2020-0802.47
2020-0902.13
2020-1002.37
2020-1102.59
2020-1202.07
2021-0102.09
2021-0202.25
2021-0302.07
2021-0403.48
2021-0502.14
2021-0612.22
2021-0702.2
2021-0802.39
2021-0903.76
2021-1003.29
2021-1113.34
2021-1204.77
2022-0102.43
2022-0202.09
2022-0301.88
2022-0401.84
2022-0501.85
2022-0602.07
2022-0701.95
2022-0812.16
2022-0901.82
2022-1002.64
2022-1102.04
2022-1202.33
2023-0101.96
2023-0202.4
2023-0301.91
2023-0402.09
2023-0501.95
2023-0602.06
2023-0702
2023-0802.32
2023-0901.98
2023-1002.02
2023-1105.85
2023-1202.78
2024-0101.83
2024-0201.93
2024-0301.88
2024-0402.01
2024-0502.03
2024-0601.82
2024-0702.17
2024-0801.84
2024-0902.21
2024-1002.08
2024-1102.31
2024-1202.14
2025-0101.75
2025-0202.61
2025-0302.57
2025-0402.4
2025-0502.64
2025-0602.82
2025-0702.35
2025-0801.95
2025-0911.86
2025-1002.57
2025-1102.5
2025-1202.67
2026-0102.19
2026-0202.52
2026-0302.57
2026-0401.95
2026-0502.21
2026-0601.92
This device (reports/month)Average device in JXG (reports/device/month)
Failure-mode summaryAI-generated

4 linked report narratives available — no AI summary generated yet.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2020-12-08Z-0738-2021Class IIOpen, ClassifiedThere is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.Distribution: Worldwide Distribution. US nationwide, Albania, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, Germany, Greece, Guam, Hong Kong, Hungary, India, Islamic Republic of Iran, Ireland, Israel, Italy, Latvia, Macao, Malaysia, Mauritius, Republic of Moldova, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam3,165 unitsclearance family
2020-12-08Z-0739-2021Class IIOpen, ClassifiedThere is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.Distribution: Worldwide Distribution. US nationwide, Albania, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, Germany, Greece, Guam, Hong Kong, Hungary, India, Islamic Republic of Iran, Ireland, Israel, Italy, Latvia, Macao, Malaysia, Mauritius, Republic of Moldova, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam1,926 unitsclearance family
2020-12-08Z-0740-2021Class IIOpen, ClassifiedThere is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.Distribution: Worldwide Distribution. US nationwide, Albania, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, Germany, Greece, Guam, Hong Kong, Hungary, India, Islamic Republic of Iran, Ireland, Israel, Italy, Latvia, Macao, Malaysia, Mauritius, Republic of Moldova, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam3,858 unitsclearance family
Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-09-179612164-2025-04618MalfunctionAvailableexact di
2022-08-239612164-2022-03156MalfunctionAvailableexact di
2021-11-079612164-2021-04267InjuryAvailableexact di
2021-06-289612164-2021-02507InjuryAvailableexact di
Regulatory clearances
  • 510(k)K110560Substantially equivalent (SESE) · 2011-11-18clearance family

Predicate lineage

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

None in the loaded window.

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