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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.

90 linked reportsMalfunction 88Injury 2
24572019-01: 1 reports for this device; peer average 2.71/device2019-02: 0 reports for this device; peer average 3.25/device2019-03: 0 reports for this device; peer average 3.75/device2019-04: 4 reports for this device; peer average 3.25/device2019-05: 0 reports for this device; peer average 3.8/device2019-06: 0 reports for this device; peer average 3.33/device2019-07: 3 reports for this device; peer average 3.2/device2019-08: 1 reports for this device; peer average 2.5/device2019-09: 0 reports for this device; peer average 5.25/device2019-10: 5 reports for this device; peer average 4.1/device2019-11: 0 reports for this device; peer average 3.5/device2019-12: 0 reports for this device; peer average 3.83/device2020-01: 2 reports for this device; peer average 2.38/device2020-02: 0 reports for this device; peer average 2.86/device2020-03: 1 reports for this device; peer average 3.11/device2020-04: 2 reports for this device; peer average 3.4/device2020-05: 0 reports for this device; peer average 3/device2020-06: 2 reports for this device; peer average 4.6/device2020-07: 5 reports for this device; peer average 3.64/device2020-08: 1 reports for this device; peer average 2.33/device2020-09: 0 reports for this device; peer average 4.5/device2020-10: 3 reports for this device; peer average 3/device2020-11: 2 reports for this device; peer average 7.33/device2020-12: 1 reports for this device; peer average 3.13/device2021-01: 4 reports for this device; peer average 2.44/device2021-02: 0 reports for this device; peer average 2.56/device2021-03: 0 reports for this device; peer average 5/device2021-04: 2 reports for this device; peer average 2.88/device2021-05: 0 reports for this device; peer average 4.17/device2021-06: 1 reports for this device; peer average 2.16/device2021-07: 1 reports for this device; peer average 3/device2021-08: 0 reports for this device; peer average 1.29/device2021-09: 0 reports for this device; peer average 1.8/device2021-10: 2 reports for this device; peer average 1.33/device2021-11: 0 reports for this device; peer average 2.33/device2021-12: 0 reports for this device; peer average 2.25/device2022-01: 2 reports for this device; peer average 1.5/device2022-02: 0 reports for this device; peer average 1.75/device2022-03: 0 reports for this device; peer average 1.33/device2022-04: 2 reports for this device; peer average 1.9/device2022-05: 1 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 2.17/device2022-07: 3 reports for this device; peer average 2.07/device2022-08: 0 reports for this device; peer average 1.33/device2022-09: 0 reports for this device; peer average 1.25/device2022-10: 2 reports for this device; peer average 1.71/device2022-11: 0 reports for this device; peer average 2.4/device2022-12: 0 reports for this device; peer average 1/device2023-01: 3 reports for this device; peer average 1.5/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 1.22/device2023-04: 3 reports for this device; peer average 1.64/device2023-05: 0 reports for this device; peer average 1.2/device2023-06: 0 reports for this device; peer average 1.25/device2023-07: 4 reports for this device; peer average 1.73/device2023-08: 0 reports for this device; peer average 1.43/device2023-09: 0 reports for this device; peer average 2/device2023-10: 4 reports for this device; peer average 1.88/device2023-11: 0 reports for this device; peer average 2/device2023-12: 0 reports for this device; peer average 1.57/device2024-01: 2 reports for this device; peer average 1.31/device2024-02: 2 reports for this device; peer average 1.44/device2024-03: 0 reports for this device; peer average 1.6/device2024-04: 1 reports for this device; peer average 1.56/device2024-05: 0 reports for this device; peer average 1.33/device2024-06: 0 reports for this device; peer average 1/device2024-07: 3 reports for this device; peer average 1.67/device2024-08: 0 reports for this device; peer average 1.57/device2024-09: 0 reports for this device; peer average 2.09/device2024-10: 2 reports for this device; peer average 1.45/device2024-11: 0 reports for this device; peer average 1.46/device2024-12: 0 reports for this device; peer average 1.5/device2025-01: 2 reports for this device; peer average 1.53/device2025-02: 0 reports for this device; peer average 1.71/device2025-03: 0 reports for this device; peer average 1.55/device2025-04: 2 reports for this device; peer average 1.61/device2025-05: 0 reports for this device; peer average 1.82/device2025-06: 0 reports for this device; peer average 1.44/device2025-07: 2 reports for this device; peer average 1.47/device2025-08: 0 reports for this device; peer average 3.25/device2025-09: 0 reports for this device; peer average 1.33/device2025-10: 2 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 1.43/device2025-12: 0 reports for this device; peer average 2.33/device2026-01: 2 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 1.25/device2026-04: 3 reports for this device; peer average 1.84/device2026-05: 0 reports for this device; peer average 2.71/device2026-06: 0 reports for this device; peer average 3.74/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0112.71
2019-0203.25
2019-0303.75
2019-0443.25
2019-0503.8
2019-0603.33
2019-0733.2
2019-0812.5
2019-0905.25
2019-1054.1
2019-1103.5
2019-1203.83
2020-0122.38
2020-0202.86
2020-0313.11
2020-0423.4
2020-0503
2020-0624.6
2020-0753.64
2020-0812.33
2020-0904.5
2020-1033
2020-1127.33
2020-1213.13
2021-0142.44
2021-0202.56
2021-0305
2021-0422.88
2021-0504.17
2021-0612.16
2021-0713
2021-0801.29
2021-0901.8
2021-1021.33
2021-1102.33
2021-1202.25
2022-0121.5
2022-0201.75
2022-0301.33
2022-0421.9
2022-0511
2022-0602.17
2022-0732.07
2022-0801.33
2022-0901.25
2022-1021.71
2022-1102.4
2022-1201
2023-0131.5
2023-0201
2023-0301.22
2023-0431.64
2023-0501.2
2023-0601.25
2023-0741.73
2023-0801.43
2023-0902
2023-1041.88
2023-1102
2023-1201.57
2024-0121.31
2024-0221.44
2024-0301.6
2024-0411.56
2024-0501.33
2024-0601
2024-0731.67
2024-0801.57
2024-0902.09
2024-1021.45
2024-1101.46
2024-1201.5
2025-0121.53
2025-0201.71
2025-0301.55
2025-0421.61
2025-0501.82
2025-0601.44
2025-0721.47
2025-0803.25
2025-0901.33
2025-1022
2025-1101.43
2025-1202.33
2026-0122
2026-0201
2026-0301.25
2026-0431.84
2026-0502.71
2026-0603.74
This device (reports/month)Average device in HBB (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
2026-04-223015967359-2026-99298MalfunctionAvailableexact di
2026-04-223015967359-2026-99258MalfunctionAvailableexact di
2026-04-223015967359-2026-99250MalfunctionAvailableexact di
2026-01-233015967359-2026-99019MalfunctionAvailableexact di
2026-01-233015967359-2026-99067MalfunctionAvailableexact di
2025-10-283015967359-2025-99402MalfunctionAvailableexact di
2025-10-233015967359-2025-99302MalfunctionAvailableexact di
2025-07-293015967359-2025-99126MalfunctionAvailableexact di
2025-07-293015967359-2025-99172MalfunctionAvailableexact di
2025-04-213015967359-2025-00762MalfunctionAvailableexact di
2025-04-213015967359-2025-00729MalfunctionAvailableexact di
2025-01-223015967359-2025-00296MalfunctionAvailableexact di
2025-01-213015967359-2025-00250MalfunctionAvailableexact di
2024-10-223015967359-2024-02073MalfunctionAvailableexact di
2024-10-213015967359-2024-01984MalfunctionAvailableexact di
Showing 1–15 of 90
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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