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.
11 linked reportsMalfunction 8Injury 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2 |
| 2019-03 | 0 | 4 |
| 2019-04 | 0 | 1 |
| 2019-05 | 0 | 1 |
| 2019-06 | 0 | 1 |
| 2019-07 | 0 | 1 |
| 2019-10 | 0 | 1 |
| 2020-03 | 0 | 1 |
| 2020-04 | 0 | 1 |
| 2020-07 | 0 | 1 |
| 2020-10 | 0 | 1 |
| 2020-11 | 0 | 1 |
| 2021-01 | 0 | 1 |
| 2021-04 | 0 | 1 |
| 2021-07 | 1 | 1 |
| 2021-10 | 0 | 2 |
| 2022-01 | 0 | 2 |
| 2022-02 | 0 | 1 |
| 2022-03 | 0 | 1 |
| 2022-07 | 0 | 1 |
| 2022-08 | 0 | 1 |
| 2022-10 | 0 | 1 |
| 2023-01 | 1 | 1.5 |
| 2023-04 | 0 | 1 |
| 2023-10 | 1 | 1 |
| 2023-11 | 0 | 1 |
| 2024-01 | 1 | 5 |
| 2024-04 | 0 | 1 |
| 2024-05 | 0 | 1 |
| 2024-06 | 0 | 1 |
| 2024-07 | 0 | 1 |
| 2024-08 | 1 | 1 |
| 2024-09 | 0 | 1 |
| 2024-10 | 1 | 1 |
| 2024-11 | 1 | 1 |
| 2025-01 | 0 | 1 |
| 2025-02 | 1 | 1 |
| 2025-03 | 0 | 1 |
| 2025-04 | 1 | 1 |
| 2025-07 | 0 | 1 |
| 2025-10 | 1 | 1 |
| 2026-01 | 0 | 1 |
| 2026-02 | 0 | 1 |
| 2026-03 | 0 | 2 |
| 2026-04 | 1 | 1 |
| 2026-05 | 0 | 2 |
| 2026-06 | 0 | 1.5 |
Failure-mode summaryAI-generated
11 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-04-22 | 3015967359-2026-99266 | Malfunction | Available | exact di |
| 2025-10-23 | 3015967359-2025-99275 | Malfunction | Available | exact di |
| 2025-04-21 | 3015967359-2025-00834 | Malfunction | Available | exact di |
| 2025-02-05 | 3015967359-2025-00388 | Injury | Available | exact di |
| 2024-11-06 | 3015967359-2024-02308 | Injury | Available | exact di |
| 2024-10-21 | 3015967359-2024-02028 | Malfunction | Available | exact di |
| 2024-08-30 | 3015967359-2024-01755 | Injury | Available | exact di |
| 2024-01-22 | 3015967359-2024-00234 | Malfunction | Available | exact di |
| 2023-10-23 | 3015967359-2023-02221 | Malfunction | Available | exact di |
| 2023-01-29 | 3015967359-2023-00173 | Malfunction | Available | exact di |
| 2021-07-21 | 3015967359-2021-01636 | Malfunction | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-06-18 | NAI | No action indicated | International Life Sciences | 0 |
| 2026-02-20 | VAI | Voluntary action indicated | Stryker Puerto Rico, LLC | 2 |
| 2025-12-11 | NAI | No action indicated | Stryker Manufacturing Kalamazoo | 0 |
| 2025-05-22 | NAI | No action indicated | Stryker Macroom | 0 |
| 2025-03-27 | VAI | Voluntary action indicated | Stryker GmbH | 1 |
| 2025-03-27 | VAI | Voluntary action indicated | Stryker GmbH | 1 |
| 2025-02-27 | NAI | No action indicated | Stryker Leibinger GmbH & Co. KG | 0 |
| 2025-01-30 | NAI | No action indicated | Serf | 0 |
| 2024-12-18 | VAI | Voluntary action indicated | Stryker Neurovascular | 1 |
| 2024-11-15 | VAI | Voluntary action indicated | Stryker Medical Division of Stryker Corporation | 2 |
| 2024-11-13 | NAI | No action indicated | POM Medical LLC | 0 |
| 2024-07-25 | VAI | Voluntary action indicated | Stryker Ireland, Ltd., Instruments Division | 1 |
| 2024-05-03 | NAI | No action indicated | Stryker Neurovascular, Inc. | 0 |
| 2024-04-18 | NAI | No action indicated | Physio-Control, Inc. | 0 |
| 2023-12-01 | VAI | Voluntary action indicated | Howmedica Osteonics Corp. | 1 |
| 2023-05-15 | VAI | Voluntary action indicated | LimFlow, Inc. | 2 |
| 2023-04-25 | NAI | No action indicated | Stryker Puerto Rico, LLC | 0 |
| 2023-01-24 | VAI | Voluntary action indicated | Stryker Corporation | 2 |
| 2023-01-24 | VAI | Voluntary action indicated | Stryker Corporation | 2 |
| 2022-03-08 | VAI | Voluntary action indicated | POM Medical LLC | 0 |
| 2017-04-06 | WL | Warning Letter | Entellus Medical Inc. | — |
| 2015-04-08 | WL | Warning Letter | Thermedx LLC | — |
| 2013-11-26 | INJ | Injunction | Physio-Control, Inc. | — |
| 2013-03-06 | WL | Warning Letter | Stryker Corporation | — |
| 2013-03-06 | WL | Warning Letter | Stryker Corporation | — |
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