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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.

2 linked reportsMalfunction 2
13452019-01: 0 reports for this device; peer average 2.57/device2019-02: 0 reports for this device; peer average 3.34/device2019-03: 0 reports for this device; peer average 3.74/device2019-04: 0 reports for this device; peer average 3.75/device2019-05: 0 reports for this device; peer average 4.47/device2019-06: 0 reports for this device; peer average 4.34/device2019-07: 0 reports for this device; peer average 3.28/device2019-08: 0 reports for this device; peer average 4.2/device2019-09: 0 reports for this device; peer average 4.39/device2019-10: 0 reports for this device; peer average 3.55/device2019-11: 0 reports for this device; peer average 4.17/device2019-12: 0 reports for this device; peer average 5.23/device2020-01: 0 reports for this device; peer average 3.83/device2020-02: 0 reports for this device; peer average 3.67/device2020-03: 0 reports for this device; peer average 5.43/device2020-04: 0 reports for this device; peer average 3.18/device2020-05: 0 reports for this device; peer average 3.39/device2020-06: 0 reports for this device; peer average 4.09/device2020-07: 0 reports for this device; peer average 3.35/device2020-08: 0 reports for this device; peer average 3.7/device2020-09: 0 reports for this device; peer average 4.4/device2020-10: 0 reports for this device; peer average 3.63/device2020-11: 0 reports for this device; peer average 4.26/device2020-12: 0 reports for this device; peer average 4.09/device2021-01: 0 reports for this device; peer average 3.41/device2021-02: 0 reports for this device; peer average 4.44/device2021-03: 0 reports for this device; peer average 4.14/device2021-04: 0 reports for this device; peer average 3.52/device2021-05: 0 reports for this device; peer average 4.14/device2021-06: 1 reports for this device; peer average 3.6/device2021-07: 0 reports for this device; peer average 3.14/device2021-08: 0 reports for this device; peer average 3.47/device2021-09: 0 reports for this device; peer average 2.94/device2021-10: 0 reports for this device; peer average 2.63/device2021-11: 0 reports for this device; peer average 3.19/device2021-12: 0 reports for this device; peer average 3.45/device2022-01: 0 reports for this device; peer average 2.89/device2022-02: 0 reports for this device; peer average 3.3/device2022-03: 0 reports for this device; peer average 3.73/device2022-04: 0 reports for this device; peer average 2.83/device2022-05: 0 reports for this device; peer average 3.4/device2022-06: 0 reports for this device; peer average 4.17/device2022-07: 0 reports for this device; peer average 3.03/device2022-08: 0 reports for this device; peer average 3.61/device2022-09: 0 reports for this device; peer average 4.98/device2022-10: 0 reports for this device; peer average 3.59/device2022-11: 0 reports for this device; peer average 4.13/device2022-12: 0 reports for this device; peer average 4.95/device2023-01: 1 reports for this device; peer average 2.81/device2023-02: 0 reports for this device; peer average 3.85/device2023-03: 0 reports for this device; peer average 3.68/device2023-04: 0 reports for this device; peer average 2.81/device2023-05: 0 reports for this device; peer average 4.17/device2023-06: 0 reports for this device; peer average 3.98/device2023-07: 0 reports for this device; peer average 3.25/device2023-08: 0 reports for this device; peer average 3.57/device2023-09: 0 reports for this device; peer average 3.49/device2023-10: 0 reports for this device; peer average 2.42/device2023-11: 0 reports for this device; peer average 4.39/device2023-12: 0 reports for this device; peer average 3.49/device2024-01: 0 reports for this device; peer average 2.91/device2024-02: 0 reports for this device; peer average 4.27/device2024-03: 0 reports for this device; peer average 3.3/device2024-04: 0 reports for this device; peer average 3.03/device2024-05: 0 reports for this device; peer average 4.22/device2024-06: 0 reports for this device; peer average 4.45/device2024-07: 0 reports for this device; peer average 2.76/device2024-08: 0 reports for this device; peer average 2.79/device2024-09: 0 reports for this device; peer average 4.14/device2024-10: 0 reports for this device; peer average 3/device2024-11: 0 reports for this device; peer average 2.93/device2024-12: 0 reports for this device; peer average 2.89/device2025-01: 0 reports for this device; peer average 2.91/device2025-02: 0 reports for this device; peer average 3.61/device2025-03: 0 reports for this device; peer average 3.28/device2025-04: 0 reports for this device; peer average 2.08/device2025-05: 0 reports for this device; peer average 4.03/device2025-06: 0 reports for this device; peer average 3.53/device2025-07: 0 reports for this device; peer average 2.85/device2025-08: 0 reports for this device; peer average 2.92/device2025-09: 0 reports for this device; peer average 2.57/device2025-10: 0 reports for this device; peer average 2.56/device2025-11: 0 reports for this device; peer average 4.02/device2025-12: 0 reports for this device; peer average 3.39/device2026-01: 0 reports for this device; peer average 2.42/device2026-02: 0 reports for this device; peer average 2.96/device2026-03: 0 reports for this device; peer average 3.04/device2026-04: 0 reports for this device; peer average 3.55/device2026-05: 0 reports for this device; peer average 3.26/device2026-06: 0 reports for this device; peer average 2.64/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.57
2019-0203.34
2019-0303.74
2019-0403.75
2019-0504.47
2019-0604.34
2019-0703.28
2019-0804.2
2019-0904.39
2019-1003.55
2019-1104.17
2019-1205.23
2020-0103.83
2020-0203.67
2020-0305.43
2020-0403.18
2020-0503.39
2020-0604.09
2020-0703.35
2020-0803.7
2020-0904.4
2020-1003.63
2020-1104.26
2020-1204.09
2021-0103.41
2021-0204.44
2021-0304.14
2021-0403.52
2021-0504.14
2021-0613.6
2021-0703.14
2021-0803.47
2021-0902.94
2021-1002.63
2021-1103.19
2021-1203.45
2022-0102.89
2022-0203.3
2022-0303.73
2022-0402.83
2022-0503.4
2022-0604.17
2022-0703.03
2022-0803.61
2022-0904.98
2022-1003.59
2022-1104.13
2022-1204.95
2023-0112.81
2023-0203.85
2023-0303.68
2023-0402.81
2023-0504.17
2023-0603.98
2023-0703.25
2023-0803.57
2023-0903.49
2023-1002.42
2023-1104.39
2023-1203.49
2024-0102.91
2024-0204.27
2024-0303.3
2024-0403.03
2024-0504.22
2024-0604.45
2024-0702.76
2024-0802.79
2024-0904.14
2024-1003
2024-1102.93
2024-1202.89
2025-0102.91
2025-0203.61
2025-0303.28
2025-0402.08
2025-0504.03
2025-0603.53
2025-0702.85
2025-0802.92
2025-0902.57
2025-1002.56
2025-1104.02
2025-1203.39
2026-0102.42
2026-0202.96
2026-0303.04
2026-0403.55
2026-0503.26
2026-0602.64
This device (reports/month)Average device in HWE (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2023-01-293015967359-2023-00190MalfunctionAvailableexact di
2021-06-213015967359-2021-01212MalfunctionAvailableexact di
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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