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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.

80 linked reportsMalfunction 80
13452019-01: 1 reports for this device; peer average 1/device2019-04: 2 reports for this device; peer average 2/device2019-07: 3 reports for this device; peer average 3/device2020-01: 2 reports for this device; peer average 2/device2020-04: 5 reports for this device; peer average 5/device2020-07: 3 reports for this device; peer average 3/device2020-10: 3 reports for this device; peer average 3/device2021-01: 2 reports for this device; peer average 2/device2021-04: 3 reports for this device; peer average 3/device2021-07: 4 reports for this device; peer average 4/device2021-10: 3 reports for this device; peer average 3/device2022-01: 2 reports for this device; peer average 2/device2022-04: 3 reports for this device; peer average 3/device2022-07: 3 reports for this device; peer average 3/device2022-10: 2 reports for this device; peer average 2/device2023-01: 3 reports for this device; peer average 3/device2023-04: 1 reports for this device; peer average 1/device2023-07: 3 reports for this device; peer average 3/device2023-10: 4 reports for this device; peer average 4/device2024-01: 1 reports for this device; peer average 1/device2024-04: 2 reports for this device; peer average 2/device2024-07: 3 reports for this device; peer average 3/device2024-10: 5 reports for this device; peer average 5/device2025-01: 3 reports for this device; peer average 3/device2025-04: 3 reports for this device; peer average 3/device2025-07: 3 reports for this device; peer average 3/device2025-10: 3 reports for this device; peer average 3/device2026-01: 2 reports for this device; peer average 2/device2026-04: 3 reports for this device; peer average 3/device0104070104071001040710010407100104071001040710010407100104
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0111
2019-0422
2019-0733
2020-0122
2020-0455
2020-0733
2020-1033
2021-0122
2021-0433
2021-0744
2021-1033
2022-0122
2022-0433
2022-0733
2022-1022
2023-0133
2023-0411
2023-0733
2023-1044
2024-0111
2024-0422
2024-0733
2024-1055
2025-0133
2025-0433
2025-0733
2025-1033
2026-0122
2026-0433
This device (reports/month)Average device in FZM (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2021-05-12Z-2206-2021Class IIOpen, ClassifiedMedical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionalsDistribution: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.4 unitscode info di
Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-04-220001831750-2026-99151MalfunctionAvailableexact di
2026-04-220001831750-2026-99149MalfunctionAvailableexact di
2026-04-220001831750-2026-99153MalfunctionAvailableexact di
2026-01-230001831750-2026-99008MalfunctionAvailableexact di
2026-01-230001831750-2026-99005MalfunctionAvailableexact di
2025-10-240001831750-2025-99279MalfunctionAvailableexact di
2025-10-240001831750-2025-99276MalfunctionAvailableexact di
2025-10-240001831750-2025-99282MalfunctionAvailableexact di
2025-07-220001831750-2025-99005MalfunctionAvailableexact di
2025-07-220001831750-2025-99012MalfunctionAvailableexact di
2025-07-220001831750-2025-99010MalfunctionAvailableexact di
2025-04-280001831750-2025-00578MalfunctionAvailableexact di
2025-04-250001831750-2025-00353MalfunctionAvailableexact di
2025-04-250001831750-2025-00352MalfunctionAvailableexact di
2025-01-240001831750-2025-00019MalfunctionAvailableexact di
Showing 1–15 of 80
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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