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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.

6 linked reportsMalfunction 4Injury 2
23562019-01: 0 reports for this device; peer average 2.25/device2019-02: 0 reports for this device; peer average 1.5/device2019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1.2/device2019-06: 0 reports for this device; peer average 1.67/device2019-07: 0 reports for this device; peer average 1.25/device2019-08: 1 reports for this device; peer average 2.25/device2019-09: 0 reports for this device; peer average 2.75/device2019-10: 0 reports for this device; peer average 1.2/device2019-11: 0 reports for this device; peer average 2.25/device2019-12: 0 reports for this device; peer average 2.25/device2020-01: 0 reports for this device; peer average 2.75/device2020-02: 0 reports for this device; peer average 1.17/device2020-03: 0 reports for this device; peer average 1.29/device2020-04: 0 reports for this device; peer average 1.5/device2020-05: 0 reports for this device; peer average 1.5/device2020-06: 0 reports for this device; peer average 1.75/device2020-07: 0 reports for this device; peer average 1.92/device2020-08: 0 reports for this device; peer average 1.43/device2020-09: 0 reports for this device; peer average 3.2/device2020-10: 0 reports for this device; peer average 3.67/device2020-11: 0 reports for this device; peer average 1.13/device2020-12: 0 reports for this device; peer average 6/device2021-01: 0 reports for this device; peer average 2.67/device2021-02: 0 reports for this device; peer average 2.5/device2021-03: 0 reports for this device; peer average 2.8/device2021-04: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 1.67/device2021-06: 0 reports for this device; peer average 2.13/device2021-07: 0 reports for this device; peer average 1.36/device2021-08: 0 reports for this device; peer average 3/device2021-09: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 1.71/device2021-11: 0 reports for this device; peer average 2.2/device2021-12: 0 reports for this device; peer average 1.4/device2022-01: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 2/device2022-03: 0 reports for this device; peer average 1.2/device2022-04: 0 reports for this device; peer average 1.57/device2022-05: 0 reports for this device; peer average 1.33/device2022-06: 0 reports for this device; peer average 2/device2022-07: 0 reports for this device; peer average 2/device2022-08: 0 reports for this device; peer average 1.54/device2022-09: 0 reports for this device; peer average 1.38/device2022-10: 2 reports for this device; peer average 1.25/device2022-11: 0 reports for this device; peer average 1.43/device2022-12: 0 reports for this device; peer average 1.5/device2023-01: 0 reports for this device; peer average 1.4/device2023-02: 0 reports for this device; peer average 2.67/device2023-03: 2 reports for this device; peer average 4/device2023-04: 1 reports for this device; peer average 1.75/device2023-05: 0 reports for this device; peer average 1.33/device2023-06: 0 reports for this device; peer average 1.86/device2023-07: 0 reports for this device; peer average 2.6/device2023-08: 0 reports for this device; peer average 1.56/device2023-09: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1.8/device2023-11: 0 reports for this device; peer average 1.25/device2023-12: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 1.43/device2024-02: 0 reports for this device; peer average 1.5/device2024-03: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 2.5/device2024-05: 0 reports for this device; peer average 1.33/device2024-06: 0 reports for this device; peer average 1.4/device2024-07: 0 reports for this device; peer average 2.57/device2024-08: 0 reports for this device; peer average 3/device2024-09: 0 reports for this device; peer average 2.25/device2024-10: 0 reports for this device; peer average 1.4/device2024-11: 0 reports for this device; peer average 1/device2024-12: 0 reports for this device; peer average 2.57/device2025-01: 0 reports for this device; peer average 1.22/device2025-02: 0 reports for this device; peer average 1.4/device2025-03: 0 reports for this device; peer average 1.29/device2025-04: 0 reports for this device; peer average 1.89/device2025-05: 0 reports for this device; peer average 1.58/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 2.19/device2025-08: 0 reports for this device; peer average 1.8/device2025-09: 0 reports for this device; peer average 2.29/device2025-10: 0 reports for this device; peer average 2.42/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 2.6/device2026-01: 0 reports for this device; peer average 1.78/device2026-02: 0 reports for this device; peer average 4.25/device2026-03: 0 reports for this device; peer average 1.94/device2026-04: 0 reports for this device; peer average 2.5/device2026-05: 0 reports for this device; peer average 1.33/device2026-06: 0 reports for this device; peer average 1.44/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.25
2019-0201.5
2019-0302
2019-0401
2019-0501.2
2019-0601.67
2019-0701.25
2019-0812.25
2019-0902.75
2019-1001.2
2019-1102.25
2019-1202.25
2020-0102.75
2020-0201.17
2020-0301.29
2020-0401.5
2020-0501.5
2020-0601.75
2020-0701.92
2020-0801.43
2020-0903.2
2020-1003.67
2020-1101.13
2020-1206
2021-0102.67
2021-0202.5
2021-0302.8
2021-0402
2021-0501.67
2021-0602.13
2021-0701.36
2021-0803
2021-0902
2021-1001.71
2021-1102.2
2021-1201.4
2022-0101
2022-0202
2022-0301.2
2022-0401.57
2022-0501.33
2022-0602
2022-0702
2022-0801.54
2022-0901.38
2022-1021.25
2022-1101.43
2022-1201.5
2023-0101.4
2023-0202.67
2023-0324
2023-0411.75
2023-0501.33
2023-0601.86
2023-0702.6
2023-0801.56
2023-0901
2023-1001.8
2023-1101.25
2023-1202
2024-0101.43
2024-0201.5
2024-0302
2024-0402.5
2024-0501.33
2024-0601.4
2024-0702.57
2024-0803
2024-0902.25
2024-1001.4
2024-1101
2024-1202.57
2025-0101.22
2025-0201.4
2025-0301.29
2025-0401.89
2025-0501.58
2025-0602
2025-0702.19
2025-0801.8
2025-0902.29
2025-1002.42
2025-1101
2025-1202.6
2026-0101.78
2026-0204.25
2026-0301.94
2026-0402.5
2026-0501.33
2026-0601.44
This device (reports/month)Average device in NDN (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2023-04-240001811755-2023-00046MalfunctionAvailableexact di
2023-03-0316477418MalfunctionAvailablecatalog number
2022-10-243015967359-2022-01983MalfunctionAvailableexact di
2022-10-113015967359-2022-01890InjuryAvailableexact di
2019-08-270001811755-2019-02823InjuryAvailableexact di

Showing the most recent 5 of 6 linked reports.

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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