Skip to content
Regulatory presence across jurisdictions

The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.

  • European UnionAHTO08858251005747U4
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.

2 linked reportsMalfunction 2
132640532019-01: 0 reports for this device; peer average 2/device2019-02: 0 reports for this device; peer average 3/device2019-03: 0 reports for this device; peer average 2.33/device2019-04: 1 reports for this device; peer average 1.14/device2019-05: 0 reports for this device; peer average 1.7/device2019-06: 0 reports for this device; peer average 1.63/device2019-07: 0 reports for this device; peer average 1.17/device2019-08: 0 reports for this device; peer average 1.57/device2019-09: 0 reports for this device; peer average 1.8/device2019-10: 0 reports for this device; peer average 1.67/device2019-11: 0 reports for this device; peer average 1.5/device2019-12: 0 reports for this device; peer average 2/device2020-01: 0 reports for this device; peer average 2.38/device2020-02: 0 reports for this device; peer average 1.33/device2020-03: 0 reports for this device; peer average 2.4/device2020-04: 0 reports for this device; peer average 3.22/device2020-05: 0 reports for this device; peer average 2.57/device2020-06: 0 reports for this device; peer average 3.92/device2020-07: 0 reports for this device; peer average 4.71/device2020-08: 0 reports for this device; peer average 5.08/device2020-09: 0 reports for this device; peer average 3.8/device2020-10: 0 reports for this device; peer average 4.89/device2020-11: 0 reports for this device; peer average 5.55/device2020-12: 0 reports for this device; peer average 5.82/device2021-01: 0 reports for this device; peer average 5.6/device2021-02: 0 reports for this device; peer average 4.9/device2021-03: 0 reports for this device; peer average 7/device2021-04: 0 reports for this device; peer average 8.56/device2021-05: 0 reports for this device; peer average 9.21/device2021-06: 0 reports for this device; peer average 7.56/device2021-07: 0 reports for this device; peer average 5.05/device2021-08: 0 reports for this device; peer average 5.82/device2021-09: 0 reports for this device; peer average 5.79/device2021-10: 0 reports for this device; peer average 6.86/device2021-11: 0 reports for this device; peer average 4.64/device2021-12: 0 reports for this device; peer average 8.11/device2022-01: 0 reports for this device; peer average 9.48/device2022-02: 0 reports for this device; peer average 22/device2022-03: 0 reports for this device; peer average 14/device2022-04: 0 reports for this device; peer average 16.39/device2022-05: 0 reports for this device; peer average 11.5/device2022-06: 0 reports for this device; peer average 17.82/device2022-07: 0 reports for this device; peer average 13.45/device2022-08: 0 reports for this device; peer average 14.1/device2022-09: 0 reports for this device; peer average 12.25/device2022-10: 0 reports for this device; peer average 12.89/device2022-11: 0 reports for this device; peer average 10.67/device2022-12: 0 reports for this device; peer average 20.35/device2023-01: 0 reports for this device; peer average 16.48/device2023-02: 0 reports for this device; peer average 13.92/device2023-03: 0 reports for this device; peer average 20.81/device2023-04: 0 reports for this device; peer average 16.08/device2023-05: 0 reports for this device; peer average 14.12/device2023-06: 0 reports for this device; peer average 15.03/device2023-07: 0 reports for this device; peer average 14.21/device2023-08: 0 reports for this device; peer average 13.97/device2023-09: 0 reports for this device; peer average 19.59/device2023-10: 0 reports for this device; peer average 13.44/device2023-11: 0 reports for this device; peer average 21.19/device2023-12: 0 reports for this device; peer average 14.57/device2024-01: 0 reports for this device; peer average 11.53/device2024-02: 0 reports for this device; peer average 12.93/device2024-03: 0 reports for this device; peer average 12.56/device2024-04: 0 reports for this device; peer average 22.26/device2024-05: 0 reports for this device; peer average 32.5/device2024-06: 0 reports for this device; peer average 36.09/device2024-07: 0 reports for this device; peer average 36.16/device2024-08: 0 reports for this device; peer average 33.81/device2024-09: 0 reports for this device; peer average 34.19/device2024-10: 0 reports for this device; peer average 33.85/device2024-11: 0 reports for this device; peer average 21.03/device2024-12: 0 reports for this device; peer average 26.53/device2025-01: 0 reports for this device; peer average 29.74/device2025-02: 0 reports for this device; peer average 27/device2025-03: 0 reports for this device; peer average 27.03/device2025-04: 0 reports for this device; peer average 23.91/device2025-05: 0 reports for this device; peer average 24.03/device2025-06: 0 reports for this device; peer average 22.55/device2025-07: 0 reports for this device; peer average 22.88/device2025-08: 0 reports for this device; peer average 24.03/device2025-09: 0 reports for this device; peer average 21.03/device2025-10: 0 reports for this device; peer average 25.5/device2025-11: 0 reports for this device; peer average 33.4/device2025-12: 0 reports for this device; peer average 52.77/device2026-01: 0 reports for this device; peer average 29.93/device2026-02: 0 reports for this device; peer average 29.09/device2026-03: 1 reports for this device; peer average 34.38/device2026-04: 0 reports for this device; peer average 47.86/device2026-05: 0 reports for this device; peer average 38.52/device2026-06: 0 reports for this device; peer average 25.58/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0203
2019-0302.33
2019-0411.14
2019-0501.7
2019-0601.63
2019-0701.17
2019-0801.57
2019-0901.8
2019-1001.67
2019-1101.5
2019-1202
2020-0102.38
2020-0201.33
2020-0302.4
2020-0403.22
2020-0502.57
2020-0603.92
2020-0704.71
2020-0805.08
2020-0903.8
2020-1004.89
2020-1105.55
2020-1205.82
2021-0105.6
2021-0204.9
2021-0307
2021-0408.56
2021-0509.21
2021-0607.56
2021-0705.05
2021-0805.82
2021-0905.79
2021-1006.86
2021-1104.64
2021-1208.11
2022-0109.48
2022-02022
2022-03014
2022-04016.39
2022-05011.5
2022-06017.82
2022-07013.45
2022-08014.1
2022-09012.25
2022-10012.89
2022-11010.67
2022-12020.35
2023-01016.48
2023-02013.92
2023-03020.81
2023-04016.08
2023-05014.12
2023-06015.03
2023-07014.21
2023-08013.97
2023-09019.59
2023-10013.44
2023-11021.19
2023-12014.57
2024-01011.53
2024-02012.93
2024-03012.56
2024-04022.26
2024-05032.5
2024-06036.09
2024-07036.16
2024-08033.81
2024-09034.19
2024-10033.85
2024-11021.03
2024-12026.53
2025-01029.74
2025-02027
2025-03027.03
2025-04023.91
2025-05024.03
2025-06022.55
2025-07022.88
2025-08024.03
2025-09021.03
2025-10025.5
2025-11033.4
2025-12052.77
2026-01029.93
2026-02029.09
2026-03134.38
2026-04047.86
2026-05038.52
2026-06025.58
This device (reports/month)Average device in GCX, HET, KQT (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2017-11-17Z-0836-2018Class IITerminatedRoutine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.Distribution: Distributed domestically to . Distributed internationally to Australia and Mexico.60,753 units totalclearance family
Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-03-230002936485-2026-00168MalfunctionAvailableexact di
2019-04-110002936485-2019-00139MalfunctionAvailableexact di
Regulatory clearances

    Predicate lineage

    K042454

    Cited as predicate by: K122619, K173111

    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—
    Similar devices
    Select up to two to place side-by-side with this device.