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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.

100 linked reportsMalfunction 98Injury 2
23562019-01: 2 reports for this device; peer average 1.41/device2019-02: 0 reports for this device; peer average 1.44/device2019-03: 1 reports for this device; peer average 1.62/device2019-04: 3 reports for this device; peer average 1.4/device2019-05: 0 reports for this device; peer average 1.35/device2019-06: 2 reports for this device; peer average 1.56/device2019-07: 2 reports for this device; peer average 1.47/device2019-08: 3 reports for this device; peer average 1.71/device2019-09: 0 reports for this device; peer average 1.4/device2019-10: 1 reports for this device; peer average 1.44/device2019-11: 4 reports for this device; peer average 1.67/device2019-12: 1 reports for this device; peer average 1.5/device2020-01: 0 reports for this device; peer average 1.53/device2020-02: 0 reports for this device; peer average 1.4/device2020-03: 0 reports for this device; peer average 1.43/device2020-04: 1 reports for this device; peer average 1.96/device2020-05: 3 reports for this device; peer average 1.84/device2020-06: 1 reports for this device; peer average 2.15/device2020-07: 2 reports for this device; peer average 2.29/device2020-08: 5 reports for this device; peer average 3.06/device2020-09: 2 reports for this device; peer average 2.11/device2020-10: 4 reports for this device; peer average 2.5/device2020-11: 0 reports for this device; peer average 3.28/device2020-12: 0 reports for this device; peer average 3.43/device2021-01: 2 reports for this device; peer average 3.12/device2021-02: 1 reports for this device; peer average 3.06/device2021-03: 0 reports for this device; peer average 3.26/device2021-04: 0 reports for this device; peer average 3.44/device2021-05: 3 reports for this device; peer average 4.35/device2021-06: 0 reports for this device; peer average 3.12/device2021-07: 1 reports for this device; peer average 2.45/device2021-08: 0 reports for this device; peer average 2.05/device2021-09: 2 reports for this device; peer average 2.24/device2021-10: 2 reports for this device; peer average 1.74/device2021-11: 2 reports for this device; peer average 3.41/device2021-12: 0 reports for this device; peer average 2.36/device2022-01: 1 reports for this device; peer average 2.92/device2022-02: 0 reports for this device; peer average 2.06/device2022-03: 3 reports for this device; peer average 2.25/device2022-04: 0 reports for this device; peer average 2.35/device2022-05: 2 reports for this device; peer average 2.06/device2022-06: 1 reports for this device; peer average 2.2/device2022-07: 4 reports for this device; peer average 1.78/device2022-08: 0 reports for this device; peer average 1.88/device2022-09: 1 reports for this device; peer average 2.28/device2022-10: 0 reports for this device; peer average 2.35/device2022-11: 1 reports for this device; peer average 2.23/device2022-12: 1 reports for this device; peer average 2.13/device2023-01: 0 reports for this device; peer average 2.14/device2023-02: 1 reports for this device; peer average 2.19/device2023-03: 1 reports for this device; peer average 2.56/device2023-04: 0 reports for this device; peer average 2.33/device2023-05: 6 reports for this device; peer average 2.56/device2023-06: 4 reports for this device; peer average 2.56/device2023-07: 1 reports for this device; peer average 1.93/device2023-08: 1 reports for this device; peer average 1.68/device2023-09: 1 reports for this device; peer average 1.41/device2023-10: 0 reports for this device; peer average 1.43/device2023-11: 0 reports for this device; peer average 1.5/device2023-12: 3 reports for this device; peer average 1.51/device2024-01: 0 reports for this device; peer average 1.56/device2024-02: 3 reports for this device; peer average 1.42/device2024-03: 0 reports for this device; peer average 1.7/device2024-04: 0 reports for this device; peer average 1.4/device2024-05: 0 reports for this device; peer average 1.7/device2024-06: 1 reports for this device; peer average 1.71/device2024-07: 1 reports for this device; peer average 1.43/device2024-08: 0 reports for this device; peer average 1.92/device2024-09: 1 reports for this device; peer average 2.2/device2024-10: 0 reports for this device; peer average 1.64/device2024-11: 0 reports for this device; peer average 1.51/device2024-12: 0 reports for this device; peer average 1.62/device2025-01: 0 reports for this device; peer average 1.66/device2025-02: 0 reports for this device; peer average 1.51/device2025-03: 2 reports for this device; peer average 1.53/device2025-04: 0 reports for this device; peer average 1.54/device2025-05: 1 reports for this device; peer average 1.51/device2025-06: 0 reports for this device; peer average 1.43/device2025-07: 0 reports for this device; peer average 1.54/device2025-08: 1 reports for this device; peer average 1.48/device2025-09: 0 reports for this device; peer average 1.38/device2025-10: 1 reports for this device; peer average 1.61/device2025-11: 0 reports for this device; peer average 1.75/device2025-12: 2 reports for this device; peer average 1.77/device2026-01: 0 reports for this device; peer average 1.85/device2026-02: 1 reports for this device; peer average 1.47/device2026-03: 3 reports for this device; peer average 1.77/device2026-04: 0 reports for this device; peer average 1.6/device2026-05: 1 reports for this device; peer average 1.67/device2026-06: 0 reports for this device; peer average 1.59/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0121.41
2019-0201.44
2019-0311.62
2019-0431.4
2019-0501.35
2019-0621.56
2019-0721.47
2019-0831.71
2019-0901.4
2019-1011.44
2019-1141.67
2019-1211.5
2020-0101.53
2020-0201.4
2020-0301.43
2020-0411.96
2020-0531.84
2020-0612.15
2020-0722.29
2020-0853.06
2020-0922.11
2020-1042.5
2020-1103.28
2020-1203.43
2021-0123.12
2021-0213.06
2021-0303.26
2021-0403.44
2021-0534.35
2021-0603.12
2021-0712.45
2021-0802.05
2021-0922.24
2021-1021.74
2021-1123.41
2021-1202.36
2022-0112.92
2022-0202.06
2022-0332.25
2022-0402.35
2022-0522.06
2022-0612.2
2022-0741.78
2022-0801.88
2022-0912.28
2022-1002.35
2022-1112.23
2022-1212.13
2023-0102.14
2023-0212.19
2023-0312.56
2023-0402.33
2023-0562.56
2023-0642.56
2023-0711.93
2023-0811.68
2023-0911.41
2023-1001.43
2023-1101.5
2023-1231.51
2024-0101.56
2024-0231.42
2024-0301.7
2024-0401.4
2024-0501.7
2024-0611.71
2024-0711.43
2024-0801.92
2024-0912.2
2024-1001.64
2024-1101.51
2024-1201.62
2025-0101.66
2025-0201.51
2025-0321.53
2025-0401.54
2025-0511.51
2025-0601.43
2025-0701.54
2025-0811.48
2025-0901.38
2025-1011.61
2025-1101.75
2025-1221.77
2026-0101.85
2026-0211.47
2026-0331.77
2026-0401.6
2026-0511.67
2026-0601.59
This device (reports/month)Average device in HSB (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
2026-05-190008031020-2026-00674MalfunctionAvailableexact di
2026-03-300008031020-2026-00497MalfunctionAvailableexact di
2026-03-300008031020-2026-00490MalfunctionAvailableexact di
2026-03-050008031020-2026-00402MalfunctionAvailableexact di
2026-02-090008031020-2026-00139MalfunctionAvailableexact di
2025-12-180008031020-2025-02187MalfunctionAvailableexact di
2025-12-010008031020-2025-02108MalfunctionAvailableexact di
2025-10-160008031020-2025-01929MalfunctionAvailableexact di
2025-08-120008031020-2025-01341MalfunctionAvailableexact di
2025-05-080008031020-2025-00874MalfunctionAvailableexact di
2025-03-260008031020-2025-00442MalfunctionAvailableexact di
2025-03-140008031020-2025-00413MalfunctionAvailableexact di
2024-09-260009610622-2024-00841MalfunctionAvailableexact di
2024-07-050009610622-2024-00339MalfunctionAvailableexact di
2024-06-240009610622-2024-00305MalfunctionAvailableexact di

Showing the most recent 95 of 100 linked reports.

Showing 1–15 of 95
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2026-06-18NAINo action indicatedInternational Life Sciences0
2026-02-20VAIVoluntary action indicatedStryker Puerto Rico, LLC2
2025-12-11NAINo action indicatedStryker Manufacturing Kalamazoo0
2025-05-22NAINo action indicatedStryker Macroom0
2025-03-27VAIVoluntary action indicatedStryker GmbH1
2025-03-27VAIVoluntary action indicatedStryker GmbH1
2025-02-27NAINo action indicatedStryker Leibinger GmbH & Co. KG0
2025-01-30NAINo action indicatedSerf0
2024-12-18VAIVoluntary action indicatedStryker Neurovascular1
2024-11-15VAIVoluntary action indicatedStryker Medical Division of Stryker Corporation2
2024-11-13NAINo action indicatedPOM Medical LLC0
2024-07-25VAIVoluntary action indicatedStryker Ireland, Ltd., Instruments Division1
2024-05-03NAINo action indicatedStryker Neurovascular, Inc.0
2024-04-18NAINo action indicatedPhysio-Control, Inc.0
2023-12-01VAIVoluntary action indicatedHowmedica Osteonics Corp.1
2023-05-15VAIVoluntary action indicatedLimFlow, Inc.2
2023-04-25NAINo action indicatedStryker Puerto Rico, LLC0
2023-01-24VAIVoluntary action indicatedStryker Corporation2
2023-01-24VAIVoluntary action indicatedStryker Corporation2
2022-03-08VAIVoluntary action indicatedPOM Medical LLC0
2017-04-06WLWarning LetterEntellus Medical Inc.—
2015-04-08WLWarning LetterThermedx LLC—
2013-11-26INJInjunctionPhysio-Control, Inc.—
2013-03-06WLWarning LetterStryker Corporation—
2013-03-06WLWarning LetterStryker Corporation—
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