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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.

1,082 linked reportsMalfunction 685Injury 349Death 48
173552692019-01: 6 reports for this device; peer average 6.5/device2019-02: 1 reports for this device; peer average 4.38/device2019-03: 6 reports for this device; peer average 8.1/device2019-04: 32 reports for this device; peer average 10.93/device2019-05: 3 reports for this device; peer average 6.82/device2019-06: 12 reports for this device; peer average 7.85/device2019-07: 48 reports for this device; peer average 11.53/device2019-08: 17 reports for this device; peer average 9.71/device2019-09: 28 reports for this device; peer average 14.71/device2019-10: 49 reports for this device; peer average 11.63/device2019-11: 27 reports for this device; peer average 9.77/device2019-12: 10 reports for this device; peer average 9.6/device2020-01: 69 reports for this device; peer average 17.29/device2020-02: 11 reports for this device; peer average 14.6/device2020-03: 9 reports for this device; peer average 9.91/device2020-04: 25 reports for this device; peer average 14.76/device2020-05: 7 reports for this device; peer average 5.29/device2020-06: 11 reports for this device; peer average 7.86/device2020-07: 45 reports for this device; peer average 19.07/device2020-08: 12 reports for this device; peer average 7.11/device2020-09: 6 reports for this device; peer average 7/device2020-10: 61 reports for this device; peer average 26.67/device2020-11: 31 reports for this device; peer average 9.5/device2020-12: 24 reports for this device; peer average 8.95/device2021-01: 31 reports for this device; peer average 11.38/device2021-02: 15 reports for this device; peer average 18.95/device2021-03: 58 reports for this device; peer average 11.24/device2021-04: 37 reports for this device; peer average 9.75/device2021-05: 15 reports for this device; peer average 8/device2021-06: 12 reports for this device; peer average 14.19/device2021-07: 33 reports for this device; peer average 11.14/device2021-08: 9 reports for this device; peer average 8.06/device2021-09: 9 reports for this device; peer average 7.27/device2021-10: 40 reports for this device; peer average 6.26/device2021-11: 6 reports for this device; peer average 9.09/device2021-12: 4 reports for this device; peer average 8.44/device2022-01: 9 reports for this device; peer average 5.14/device2022-02: 9 reports for this device; peer average 4.74/device2022-03: 18 reports for this device; peer average 4.86/device2022-04: 24 reports for this device; peer average 6/device2022-05: 11 reports for this device; peer average 11.64/device2022-06: 3 reports for this device; peer average 4.77/device2022-07: 9 reports for this device; peer average 4.36/device2022-08: 3 reports for this device; peer average 4.7/device2022-09: 3 reports for this device; peer average 4/device2022-10: 2 reports for this device; peer average 3.17/device2022-11: 3 reports for this device; peer average 1.83/device2022-12: 11 reports for this device; peer average 4.44/device2023-01: 6 reports for this device; peer average 3.69/device2023-02: 6 reports for this device; peer average 3.4/device2023-03: 9 reports for this device; peer average 3.6/device2023-04: 0 reports for this device; peer average 2.83/device2023-05: 3 reports for this device; peer average 4/device2023-06: 3 reports for this device; peer average 7.22/device2023-07: 6 reports for this device; peer average 3.8/device2023-08: 6 reports for this device; peer average 3/device2023-09: 4 reports for this device; peer average 2.08/device2023-10: 4 reports for this device; peer average 3.78/device2023-11: 3 reports for this device; peer average 2.67/device2023-12: 10 reports for this device; peer average 4.78/device2024-01: 2 reports for this device; peer average 1.6/device2024-02: 8 reports for this device; peer average 3.2/device2024-03: 8 reports for this device; peer average 3.5/device2024-04: 6 reports for this device; peer average 3.57/device2024-05: 2 reports for this device; peer average 2.5/device2024-06: 8 reports for this device; peer average 4.17/device2024-07: 0 reports for this device; peer average 2.4/device2024-08: 0 reports for this device; peer average 3.14/device2024-09: 4 reports for this device; peer average 3/device2024-10: 4 reports for this device; peer average 2.83/device2024-11: 4 reports for this device; peer average 2.38/device2024-12: 1 reports for this device; peer average 4.4/device2025-01: 0 reports for this device; peer average 1.5/device2025-02: 0 reports for this device; peer average 1.57/device2025-03: 0 reports for this device; peer average 3.6/device2025-04: 2 reports for this device; peer average 1.57/device2025-05: 4 reports for this device; peer average 4.33/device2025-06: 4 reports for this device; peer average 4.2/device2025-07: 0 reports for this device; peer average 3.14/device2025-08: 0 reports for this device; peer average 2.75/device2025-09: 0 reports for this device; peer average 3.57/device2025-10: 4 reports for this device; peer average 3.8/device2025-11: 10 reports for this device; peer average 3.6/device2025-12: 0 reports for this device; peer average 2.83/device2026-01: 4 reports for this device; peer average 3.5/device2026-02: 6 reports for this device; peer average 4.2/device2026-03: 11 reports for this device; peer average 6.2/device2026-04: 4 reports for this device; peer average 2.25/device2026-05: 0 reports for this device; peer average 3.33/device2026-06: 2 reports for this device; peer average 2.25/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0166.5
2019-0214.38
2019-0368.1
2019-043210.93
2019-0536.82
2019-06127.85
2019-074811.53
2019-08179.71
2019-092814.71
2019-104911.63
2019-11279.77
2019-12109.6
2020-016917.29
2020-021114.6
2020-0399.91
2020-042514.76
2020-0575.29
2020-06117.86
2020-074519.07
2020-08127.11
2020-0967
2020-106126.67
2020-11319.5
2020-12248.95
2021-013111.38
2021-021518.95
2021-035811.24
2021-04379.75
2021-05158
2021-061214.19
2021-073311.14
2021-0898.06
2021-0997.27
2021-10406.26
2021-1169.09
2021-1248.44
2022-0195.14
2022-0294.74
2022-03184.86
2022-04246
2022-051111.64
2022-0634.77
2022-0794.36
2022-0834.7
2022-0934
2022-1023.17
2022-1131.83
2022-12114.44
2023-0163.69
2023-0263.4
2023-0393.6
2023-0402.83
2023-0534
2023-0637.22
2023-0763.8
2023-0863
2023-0942.08
2023-1043.78
2023-1132.67
2023-12104.78
2024-0121.6
2024-0283.2
2024-0383.5
2024-0463.57
2024-0522.5
2024-0684.17
2024-0702.4
2024-0803.14
2024-0943
2024-1042.83
2024-1142.38
2024-1214.4
2025-0101.5
2025-0201.57
2025-0303.6
2025-0421.57
2025-0544.33
2025-0644.2
2025-0703.14
2025-0802.75
2025-0903.57
2025-1043.8
2025-11103.6
2025-1202.83
2026-0143.5
2026-0264.2
2026-03116.2
2026-0442.25
2026-0503.33
2026-0622.25
This device (reports/month)Average device in DTK (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-06-182020394-2026-01549MalfunctionAvailablecatalog number
2026-04-282020394-2026-01035MalfunctionAvailablecatalog number
2026-04-172020394-2026-00952MalfunctionAvailablecatalog number
2026-03-232020394-2026-00692MalfunctionAvailablecatalog number
2026-03-112020394-2026-00634MalfunctionAvailablecatalog number
2026-03-092020394-2026-00623MalfunctionAvailablecatalog number
2026-03-0224477933MalfunctionAvailablecatalog number
2026-03-0224477513MalfunctionAvailablecatalog number
2026-02-272020394-2026-00482MalfunctionAvailablecatalog number
2026-02-192020394-2026-00319MalfunctionAvailablecatalog number
2026-02-132020394-2026-00272MalfunctionAvailablecatalog number
2026-01-052020394-2025-02311MalfunctionAvailablecatalog number
2026-01-052020394-2025-02315MalfunctionAvailablecatalog number
2025-11-172020394-2025-01889MalfunctionAvailablecatalog number
2025-11-122020394-2025-01856MalfunctionAvailablecatalog number

Showing the most recent 200 of 1,082 linked reports.

Showing 1–15 of 200
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2026-04-21NAINo action indicatedBard Peripheral Vascular Inc0
2024-03-08NAINo action indicatedBard Peripheral Vascular Inc0
2018-11-02NAINo action indicatedBard Peripheral Vascular Inc0
2017-02-03NAINo action indicatedBard Peripheral Vascular Inc0
2016-11-01NAINo action indicatedBard Peripheral Vascular Inc0
2016-02-26VAIVoluntary action indicatedBard Peripheral Vascular Inc2
2015-12-18VAIVoluntary action indicatedBard Peripheral Vascular Inc0
2015-01-05OAIOfficial action indicatedBard Peripheral Vascular Inc3
2014-03-20NAINo action indicatedBard Peripheral Vascular Inc0
2014-02-24NAINo action indicatedBard Peripheral Vascular Inc0
2011-08-05NAINo action indicatedBard Peripheral Vascular Inc0
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