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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.

1 linked reportMalfunction 1
12342019-01: 0 reports for this device; peer average 1.64/device2019-02: 0 reports for this device; peer average 1.52/device2019-03: 0 reports for this device; peer average 1.76/device2019-04: 0 reports for this device; peer average 1.69/device2019-05: 0 reports for this device; peer average 1.69/device2019-06: 0 reports for this device; peer average 1.55/device2019-07: 0 reports for this device; peer average 2.02/device2019-08: 0 reports for this device; peer average 2.38/device2019-09: 0 reports for this device; peer average 2.08/device2019-10: 0 reports for this device; peer average 2.24/device2019-11: 0 reports for this device; peer average 2.03/device2019-12: 0 reports for this device; peer average 2.52/device2020-01: 0 reports for this device; peer average 2.27/device2020-02: 0 reports for this device; peer average 2.9/device2020-03: 0 reports for this device; peer average 2.85/device2020-04: 0 reports for this device; peer average 2.16/device2020-05: 0 reports for this device; peer average 2.68/device2020-06: 0 reports for this device; peer average 2.46/device2020-07: 0 reports for this device; peer average 2.83/device2020-08: 0 reports for this device; peer average 2.54/device2020-09: 0 reports for this device; peer average 2.39/device2020-10: 0 reports for this device; peer average 2.62/device2020-11: 0 reports for this device; peer average 2.65/device2020-12: 0 reports for this device; peer average 2.71/device2021-01: 0 reports for this device; peer average 3/device2021-02: 0 reports for this device; peer average 2.12/device2021-03: 0 reports for this device; peer average 2.65/device2021-04: 0 reports for this device; peer average 2.6/device2021-05: 0 reports for this device; peer average 2.02/device2021-06: 0 reports for this device; peer average 2.4/device2021-07: 0 reports for this device; peer average 2.95/device2021-08: 0 reports for this device; peer average 2.36/device2021-09: 0 reports for this device; peer average 2.32/device2021-10: 1 reports for this device; peer average 1.97/device2021-11: 0 reports for this device; peer average 2.33/device2021-12: 0 reports for this device; peer average 2.59/device2022-01: 0 reports for this device; peer average 2.58/device2022-02: 0 reports for this device; peer average 2.37/device2022-03: 0 reports for this device; peer average 2.41/device2022-04: 0 reports for this device; peer average 2.51/device2022-05: 0 reports for this device; peer average 2.78/device2022-06: 0 reports for this device; peer average 2.69/device2022-07: 0 reports for this device; peer average 2.47/device2022-08: 0 reports for this device; peer average 2.92/device2022-09: 0 reports for this device; peer average 2.5/device2022-10: 0 reports for this device; peer average 2.18/device2022-11: 0 reports for this device; peer average 2.58/device2022-12: 0 reports for this device; peer average 2.33/device2023-01: 0 reports for this device; peer average 1.86/device2023-02: 0 reports for this device; peer average 2.53/device2023-03: 0 reports for this device; peer average 2.51/device2023-04: 0 reports for this device; peer average 2.18/device2023-05: 0 reports for this device; peer average 2.87/device2023-06: 0 reports for this device; peer average 2.34/device2023-07: 0 reports for this device; peer average 2.57/device2023-08: 0 reports for this device; peer average 2.62/device2023-09: 0 reports for this device; peer average 2.63/device2023-10: 0 reports for this device; peer average 2.51/device2023-11: 0 reports for this device; peer average 2.55/device2023-12: 0 reports for this device; peer average 2.68/device2024-01: 0 reports for this device; peer average 2.57/device2024-02: 0 reports for this device; peer average 2.6/device2024-03: 0 reports for this device; peer average 2.76/device2024-04: 0 reports for this device; peer average 2.2/device2024-05: 0 reports for this device; peer average 3.17/device2024-06: 0 reports for this device; peer average 2.94/device2024-07: 0 reports for this device; peer average 2.24/device2024-08: 0 reports for this device; peer average 3.44/device2024-09: 0 reports for this device; peer average 2.96/device2024-10: 0 reports for this device; peer average 3.8/device2024-11: 0 reports for this device; peer average 3.29/device2024-12: 0 reports for this device; peer average 3.67/device2025-01: 0 reports for this device; peer average 2.94/device2025-02: 0 reports for this device; peer average 3.07/device2025-03: 0 reports for this device; peer average 3.1/device2025-04: 0 reports for this device; peer average 3.32/device2025-05: 0 reports for this device; peer average 3.15/device2025-06: 0 reports for this device; peer average 2.88/device2025-07: 0 reports for this device; peer average 2.97/device2025-08: 0 reports for this device; peer average 3.12/device2025-09: 0 reports for this device; peer average 3.33/device2025-10: 0 reports for this device; peer average 3.11/device2025-11: 0 reports for this device; peer average 3.84/device2025-12: 0 reports for this device; peer average 4.14/device2026-01: 0 reports for this device; peer average 3.52/device2026-02: 0 reports for this device; peer average 3.82/device2026-03: 0 reports for this device; peer average 3.83/device2026-04: 0 reports for this device; peer average 2.94/device2026-05: 0 reports for this device; peer average 2.6/device2026-06: 0 reports for this device; peer average 2.77/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.64
2019-0201.52
2019-0301.76
2019-0401.69
2019-0501.69
2019-0601.55
2019-0702.02
2019-0802.38
2019-0902.08
2019-1002.24
2019-1102.03
2019-1202.52
2020-0102.27
2020-0202.9
2020-0302.85
2020-0402.16
2020-0502.68
2020-0602.46
2020-0702.83
2020-0802.54
2020-0902.39
2020-1002.62
2020-1102.65
2020-1202.71
2021-0103
2021-0202.12
2021-0302.65
2021-0402.6
2021-0502.02
2021-0602.4
2021-0702.95
2021-0802.36
2021-0902.32
2021-1011.97
2021-1102.33
2021-1202.59
2022-0102.58
2022-0202.37
2022-0302.41
2022-0402.51
2022-0502.78
2022-0602.69
2022-0702.47
2022-0802.92
2022-0902.5
2022-1002.18
2022-1102.58
2022-1202.33
2023-0101.86
2023-0202.53
2023-0302.51
2023-0402.18
2023-0502.87
2023-0602.34
2023-0702.57
2023-0802.62
2023-0902.63
2023-1002.51
2023-1102.55
2023-1202.68
2024-0102.57
2024-0202.6
2024-0302.76
2024-0402.2
2024-0503.17
2024-0602.94
2024-0702.24
2024-0803.44
2024-0902.96
2024-1003.8
2024-1103.29
2024-1203.67
2025-0102.94
2025-0203.07
2025-0303.1
2025-0403.32
2025-0503.15
2025-0602.88
2025-0702.97
2025-0803.12
2025-0903.33
2025-1003.11
2025-1103.84
2025-1204.14
2026-0103.52
2026-0203.82
2026-0303.83
2026-0402.94
2026-0502.6
2026-0602.77
This device (reports/month)Average device in DQX, MOF (reports/device/month)
Failure-mode summaryAI-generated

1 linked report narrative available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2021-10-283012931345-2021-00179MalfunctionAvailableexact di
Regulatory clearances

    Predicate lineage

    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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