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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.

101 linked reportsMalfunction 96Injury 5
4811152019-01: 1 reports for this device; peer average 1/device2019-02: 0 reports for this device; peer average 1/device2019-03: 1 reports for this device; peer average 1/device2019-04: 2 reports for this device; peer average 1.67/device2019-05: 1 reports for this device; peer average 1.2/device2019-06: 1 reports for this device; peer average 1.75/device2019-07: 0 reports for this device; peer average 4/device2019-08: 2 reports for this device; peer average 1.8/device2019-09: 5 reports for this device; peer average 2.67/device2019-10: 3 reports for this device; peer average 4.5/device2019-11: 0 reports for this device; peer average 6.5/device2019-12: 4 reports for this device; peer average 2.33/device2020-01: 5 reports for this device; peer average 4/device2020-02: 0 reports for this device; peer average 1/device2020-03: 6 reports for this device; peer average 2.67/device2020-04: 2 reports for this device; peer average 1.33/device2020-05: 8 reports for this device; peer average 8/device2020-06: 3 reports for this device; peer average 2.25/device2020-07: 2 reports for this device; peer average 1.75/device2020-08: 1 reports for this device; peer average 2/device2020-09: 2 reports for this device; peer average 1.5/device2020-10: 3 reports for this device; peer average 3.75/device2020-11: 1 reports for this device; peer average 1/device2020-12: 2 reports for this device; peer average 1.25/device2021-01: 2 reports for this device; peer average 2/device2021-02: 5 reports for this device; peer average 3.25/device2021-03: 4 reports for this device; peer average 4/device2021-04: 2 reports for this device; peer average 1.5/device2021-05: 1 reports for this device; peer average 1.5/device2021-06: 4 reports for this device; peer average 3.67/device2021-07: 0 reports for this device; peer average 1.33/device2021-08: 4 reports for this device; peer average 3.5/device2021-09: 3 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 3/device2021-11: 4 reports for this device; peer average 1.43/device2021-12: 0 reports for this device; peer average 1.25/device2022-01: 2 reports for this device; peer average 4/device2022-02: 1 reports for this device; peer average 2.5/device2022-03: 0 reports for this device; peer average 8/device2022-04: 0 reports for this device; peer average 1.5/device2022-05: 1 reports for this device; peer average 7.5/device2022-06: 2 reports for this device; peer average 4.71/device2022-07: 0 reports for this device; peer average 2.5/device2022-08: 1 reports for this device; peer average 3.8/device2022-09: 0 reports for this device; peer average 7.5/device2022-10: 0 reports for this device; peer average 7/device2022-11: 0 reports for this device; peer average 4.25/device2022-12: 0 reports for this device; peer average 6.8/device2023-01: 0 reports for this device; peer average 2.5/device2023-02: 0 reports for this device; peer average 3.33/device2023-03: 1 reports for this device; peer average 2.67/device2023-04: 1 reports for this device; peer average 2.25/device2023-05: 1 reports for this device; peer average 4.5/device2023-06: 0 reports for this device; peer average 3.5/device2023-07: 0 reports for this device; peer average 6/device2023-08: 0 reports for this device; peer average 8/device2023-09: 0 reports for this device; peer average 8.67/device2023-10: 0 reports for this device; peer average 4.75/device2023-11: 0 reports for this device; peer average 9.33/device2023-12: 1 reports for this device; peer average 1.8/device2024-01: 0 reports for this device; peer average 10/device2024-02: 0 reports for this device; peer average 3/device2024-03: 0 reports for this device; peer average 5.5/device2024-04: 0 reports for this device; peer average 7/device2024-05: 0 reports for this device; peer average 3/device2024-06: 1 reports for this device; peer average 5/device2024-07: 0 reports for this device; peer average 8.33/device2024-08: 1 reports for this device; peer average 9/device2024-09: 0 reports for this device; peer average 4.33/device2024-10: 0 reports for this device; peer average 2.75/device2024-11: 1 reports for this device; peer average 1.25/device2024-12: 0 reports for this device; peer average 4.25/device2025-01: 0 reports for this device; peer average 3.83/device2025-02: 0 reports for this device; peer average 5.17/device2025-03: 0 reports for this device; peer average 5.8/device2025-04: 0 reports for this device; peer average 6/device2025-05: 3 reports for this device; peer average 11.33/device2025-06: 0 reports for this device; peer average 5.67/device2025-07: 0 reports for this device; peer average 13/device2025-08: 0 reports for this device; peer average 15/device2025-09: 0 reports for this device; peer average 5.8/device2025-10: 0 reports for this device; peer average 3.33/device2025-11: 0 reports for this device; peer average 6.67/device2025-12: 0 reports for this device; peer average 1.67/device2026-01: 0 reports for this device; peer average 4.14/device2026-02: 0 reports for this device; peer average 3.67/device2026-03: 0 reports for this device; peer average 14.5/device2026-04: 0 reports for this device; peer average 9.33/device2026-05: 0 reports for this device; peer average 2.71/device2026-06: 0 reports for this device; peer average 3.13/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0111
2019-0201
2019-0311
2019-0421.67
2019-0511.2
2019-0611.75
2019-0704
2019-0821.8
2019-0952.67
2019-1034.5
2019-1106.5
2019-1242.33
2020-0154
2020-0201
2020-0362.67
2020-0421.33
2020-0588
2020-0632.25
2020-0721.75
2020-0812
2020-0921.5
2020-1033.75
2020-1111
2020-1221.25
2021-0122
2021-0253.25
2021-0344
2021-0421.5
2021-0511.5
2021-0643.67
2021-0701.33
2021-0843.5
2021-0932
2021-1003
2021-1141.43
2021-1201.25
2022-0124
2022-0212.5
2022-0308
2022-0401.5
2022-0517.5
2022-0624.71
2022-0702.5
2022-0813.8
2022-0907.5
2022-1007
2022-1104.25
2022-1206.8
2023-0102.5
2023-0203.33
2023-0312.67
2023-0412.25
2023-0514.5
2023-0603.5
2023-0706
2023-0808
2023-0908.67
2023-1004.75
2023-1109.33
2023-1211.8
2024-01010
2024-0203
2024-0305.5
2024-0407
2024-0503
2024-0615
2024-0708.33
2024-0819
2024-0904.33
2024-1002.75
2024-1111.25
2024-1204.25
2025-0103.83
2025-0205.17
2025-0305.8
2025-0406
2025-05311.33
2025-0605.67
2025-07013
2025-08015
2025-0905.8
2025-1003.33
2025-1106.67
2025-1201.67
2026-0104.14
2026-0203.67
2026-03014.5
2026-0409.33
2026-0502.71
2026-0603.13
This device (reports/month)Average device in FCW (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
2025-05-1922043168MalfunctionAvailablecatalog number
2024-11-270002936485-2024-00846MalfunctionAvailableexact di
2024-08-140002936485-2024-00565MalfunctionAvailableexact di
2024-06-050002936485-2024-00445MalfunctionAvailableexact di
2023-12-210002936485-2023-01317MalfunctionAvailableexact di
2023-05-090002936485-2023-00407MalfunctionAvailableexact di
2023-04-030002936485-2023-00266MalfunctionAvailableexact di
2023-03-300002936485-2023-00261MalfunctionAvailableexact di
2022-08-040002936485-2022-00446MalfunctionAvailableexact di
2022-06-210002936485-2022-00377InjuryAvailableexact di
2022-06-130002936485-2022-00322MalfunctionAvailableexact di
2022-05-200002936485-2022-00256MalfunctionAvailableexact di
2022-02-220002936485-2022-00099MalfunctionAvailableexact di
2022-01-070002936485-2022-00015MalfunctionAvailableexact di
2022-01-060002936485-2022-00010MalfunctionAvailableexact di

Showing the most recent 99 of 101 linked reports.

Showing 1–15 of 99
Regulatory clearances

    Predicate lineage

    K082813

    Cited as predicate by: K101734, K121724, K131226, K142922

    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
    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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