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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
91726352019-01: 0 reports for this device; peer average 4.17/device2019-02: 0 reports for this device; peer average 5.13/device2019-03: 0 reports for this device; peer average 3.17/device2019-04: 0 reports for this device; peer average 6.27/device2019-05: 0 reports for this device; peer average 3.42/device2019-06: 0 reports for this device; peer average 6.06/device2019-07: 0 reports for this device; peer average 5.21/device2019-08: 0 reports for this device; peer average 13.11/device2019-09: 0 reports for this device; peer average 16.23/device2019-10: 1 reports for this device; peer average 21.7/device2019-11: 0 reports for this device; peer average 34.57/device2019-12: 0 reports for this device; peer average 24.92/device2020-01: 0 reports for this device; peer average 20.06/device2020-02: 0 reports for this device; peer average 10.64/device2020-03: 0 reports for this device; peer average 10/device2020-04: 0 reports for this device; peer average 5.56/device2020-05: 0 reports for this device; peer average 7.33/device2020-06: 0 reports for this device; peer average 11.82/device2020-07: 0 reports for this device; peer average 4.86/device2020-08: 0 reports for this device; peer average 4.27/device2020-09: 0 reports for this device; peer average 6.18/device2020-10: 0 reports for this device; peer average 3.36/device2020-11: 0 reports for this device; peer average 18.22/device2020-12: 0 reports for this device; peer average 7/device2021-01: 0 reports for this device; peer average 4.87/device2021-02: 0 reports for this device; peer average 8.27/device2021-03: 0 reports for this device; peer average 10.31/device2021-04: 0 reports for this device; peer average 11.58/device2021-05: 0 reports for this device; peer average 7.07/device2021-06: 0 reports for this device; peer average 6.5/device2021-07: 0 reports for this device; peer average 7.8/device2021-08: 0 reports for this device; peer average 5/device2021-09: 0 reports for this device; peer average 3.63/device2021-10: 0 reports for this device; peer average 3.94/device2021-11: 0 reports for this device; peer average 3.64/device2021-12: 0 reports for this device; peer average 3.89/device2022-01: 0 reports for this device; peer average 3.5/device2022-02: 0 reports for this device; peer average 4.75/device2022-03: 0 reports for this device; peer average 5.7/device2022-04: 0 reports for this device; peer average 2.57/device2022-05: 0 reports for this device; peer average 3.08/device2022-06: 0 reports for this device; peer average 3/device2022-07: 0 reports for this device; peer average 4.13/device2022-08: 0 reports for this device; peer average 2.46/device2022-09: 0 reports for this device; peer average 1.85/device2022-10: 0 reports for this device; peer average 3.06/device2022-11: 0 reports for this device; peer average 2.92/device2022-12: 0 reports for this device; peer average 2.73/device2023-01: 0 reports for this device; peer average 2.2/device2023-02: 0 reports for this device; peer average 2.46/device2023-03: 0 reports for this device; peer average 4.7/device2023-04: 0 reports for this device; peer average 2.13/device2023-05: 0 reports for this device; peer average 2.33/device2023-06: 0 reports for this device; peer average 2.85/device2023-07: 0 reports for this device; peer average 2.88/device2023-08: 0 reports for this device; peer average 6.2/device2023-09: 0 reports for this device; peer average 4.08/device2023-10: 0 reports for this device; peer average 1.75/device2023-11: 0 reports for this device; peer average 2.08/device2023-12: 0 reports for this device; peer average 3.25/device2024-01: 0 reports for this device; peer average 4/device2024-02: 0 reports for this device; peer average 4.44/device2024-03: 0 reports for this device; peer average 2.31/device2024-04: 0 reports for this device; peer average 1.83/device2024-05: 0 reports for this device; peer average 4/device2024-06: 0 reports for this device; peer average 4.1/device2024-07: 0 reports for this device; peer average 2/device2024-08: 0 reports for this device; peer average 3.14/device2024-09: 0 reports for this device; peer average 2.75/device2024-10: 0 reports for this device; peer average 3.2/device2024-11: 0 reports for this device; peer average 3.33/device2024-12: 0 reports for this device; peer average 3/device2025-01: 0 reports for this device; peer average 1.93/device2025-02: 0 reports for this device; peer average 3.25/device2025-03: 0 reports for this device; peer average 2.79/device2025-04: 0 reports for this device; peer average 1.83/device2025-05: 0 reports for this device; peer average 2.82/device2025-06: 0 reports for this device; peer average 2.31/device2025-07: 0 reports for this device; peer average 2.38/device2025-08: 0 reports for this device; peer average 1.4/device2025-09: 0 reports for this device; peer average 1.67/device2025-10: 0 reports for this device; peer average 2.3/device2025-11: 0 reports for this device; peer average 2/device2025-12: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 3.13/device2026-02: 0 reports for this device; peer average 2.29/device2026-03: 0 reports for this device; peer average 10.27/device2026-04: 0 reports for this device; peer average 13.78/device2026-05: 0 reports for this device; peer average 4/device2026-06: 0 reports for this device; peer average 2/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.17
2019-0205.13
2019-0303.17
2019-0406.27
2019-0503.42
2019-0606.06
2019-0705.21
2019-08013.11
2019-09016.23
2019-10121.7
2019-11034.57
2019-12024.92
2020-01020.06
2020-02010.64
2020-03010
2020-0405.56
2020-0507.33
2020-06011.82
2020-0704.86
2020-0804.27
2020-0906.18
2020-1003.36
2020-11018.22
2020-1207
2021-0104.87
2021-0208.27
2021-03010.31
2021-04011.58
2021-0507.07
2021-0606.5
2021-0707.8
2021-0805
2021-0903.63
2021-1003.94
2021-1103.64
2021-1203.89
2022-0103.5
2022-0204.75
2022-0305.7
2022-0402.57
2022-0503.08
2022-0603
2022-0704.13
2022-0802.46
2022-0901.85
2022-1003.06
2022-1102.92
2022-1202.73
2023-0102.2
2023-0202.46
2023-0304.7
2023-0402.13
2023-0502.33
2023-0602.85
2023-0702.88
2023-0806.2
2023-0904.08
2023-1001.75
2023-1102.08
2023-1203.25
2024-0104
2024-0204.44
2024-0302.31
2024-0401.83
2024-0504
2024-0604.1
2024-0702
2024-0803.14
2024-0902.75
2024-1003.2
2024-1103.33
2024-1203
2025-0101.93
2025-0203.25
2025-0302.79
2025-0401.83
2025-0502.82
2025-0602.31
2025-0702.38
2025-0801.4
2025-0901.67
2025-1002.3
2025-1102
2025-1202
2026-0103.13
2026-0202.29
2026-03010.27
2026-04013.78
2026-0504
2026-0602
This device (reports/month)Average device in JDZ, LOD (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
2019-10-280001811755-2019-03437MalfunctionAvailableexact 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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