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.
110 linked reportsMalfunction 110
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 2 | 4.2 |
| 2019-02 | 2 | 3.58 |
| 2019-03 | 27 | 6.27 |
| 2019-04 | 10 | 5.47 |
| 2019-05 | 3 | 3.92 |
| 2019-06 | 4 | 4.13 |
| 2019-07 | 1 | 4.17 |
| 2019-08 | 2 | 5.32 |
| 2019-09 | 1 | 4.17 |
| 2019-10 | 1 | 4.24 |
| 2019-11 | 6 | 5.24 |
| 2019-12 | 5 | 5.06 |
| 2020-01 | 0 | 4.4 |
| 2020-02 | 1 | 3.92 |
| 2020-03 | 1 | 4.79 |
| 2020-04 | 1 | 4.51 |
| 2020-05 | 3 | 2.98 |
| 2020-06 | 4 | 5.68 |
| 2020-07 | 3 | 5.4 |
| 2020-08 | 1 | 4.57 |
| 2020-09 | 0 | 4.43 |
| 2020-10 | 2 | 5.14 |
| 2020-11 | 0 | 4.88 |
| 2020-12 | 2 | 5.08 |
| 2021-01 | 1 | 4.86 |
| 2021-02 | 0 | 5.1 |
| 2021-03 | 0 | 5.73 |
| 2021-04 | 0 | 4.56 |
| 2021-05 | 0 | 4.56 |
| 2021-06 | 1 | 5.43 |
| 2021-07 | 1 | 4.49 |
| 2021-08 | 2 | 4.87 |
| 2021-09 | 0 | 3.93 |
| 2021-10 | 1 | 3.19 |
| 2021-11 | 0 | 4.08 |
| 2021-12 | 0 | 3.67 |
| 2022-01 | 0 | 3.52 |
| 2022-02 | 2 | 3.15 |
| 2022-03 | 2 | 3.37 |
| 2022-04 | 0 | 3.75 |
| 2022-05 | 4 | 2.97 |
| 2022-06 | 1 | 4.16 |
| 2022-07 | 1 | 4.17 |
| 2022-08 | 0 | 4.26 |
| 2022-09 | 0 | 3.72 |
| 2022-10 | 0 | 4.13 |
| 2022-11 | 0 | 4.3 |
| 2022-12 | 0 | 4.24 |
| 2023-01 | 0 | 3.42 |
| 2023-02 | 0 | 3.95 |
| 2023-03 | 1 | 4.6 |
| 2023-04 | 2 | 4 |
| 2023-05 | 0 | 5.03 |
| 2023-06 | 5 | 3.99 |
| 2023-07 | 0 | 4.33 |
| 2023-08 | 1 | 3.73 |
| 2023-09 | 0 | 3.85 |
| 2023-10 | 1 | 3.6 |
| 2023-11 | 0 | 3.86 |
| 2023-12 | 0 | 3.34 |
| 2024-01 | 0 | 4.05 |
| 2024-02 | 0 | 4.64 |
| 2024-03 | 0 | 4.32 |
| 2024-04 | 0 | 4.26 |
| 2024-05 | 0 | 3.3 |
| 2024-06 | 0 | 3.43 |
| 2024-07 | 0 | 3.6 |
| 2024-08 | 0 | 3.6 |
| 2024-09 | 0 | 4.95 |
| 2024-10 | 0 | 4.01 |
| 2024-11 | 0 | 3.64 |
| 2024-12 | 0 | 3.46 |
| 2025-01 | 0 | 2.95 |
| 2025-02 | 0 | 6.82 |
| 2025-03 | 2 | 4.95 |
| 2025-04 | 0 | 3.08 |
| 2025-05 | 0 | 4.42 |
| 2025-06 | 0 | 3.56 |
| 2025-07 | 0 | 3.98 |
| 2025-08 | 0 | 3.5 |
| 2025-09 | 0 | 3.1 |
| 2025-10 | 0 | 3.8 |
| 2025-11 | 0 | 3.27 |
| 2025-12 | 0 | 3.46 |
| 2026-01 | 0 | 2.62 |
| 2026-02 | 0 | 3.38 |
| 2026-03 | 0 | 3.6 |
| 2026-04 | 0 | 5.25 |
| 2026-05 | 0 | 3.94 |
| 2026-06 | 0 | 4.1 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-03-06 | 3015967359-2025-00498 | Malfunction | Available | exact di |
| 2025-03-06 | 3015967359-2025-00497 | Malfunction | Available | exact di |
| 2023-10-05 | 3015967359-2023-02069 | Malfunction | Available | exact di |
| 2023-08-16 | 3015967359-2023-01851 | Malfunction | Available | exact di |
| 2023-06-30 | 3015967359-2023-01407 | Malfunction | Available | exact di |
| 2023-06-15 | 3015967359-2023-01314 | Malfunction | Available | exact di |
| 2023-06-08 | 3015967359-2023-01254 | Malfunction | Available | exact di |
| 2023-06-08 | 3015967359-2023-01256 | Malfunction | Available | exact di |
| 2023-06-07 | 3015967359-2023-01237 | Malfunction | Available | exact di |
| 2023-04-27 | 3015967359-2023-01041 | Malfunction | Available | exact di |
| 2023-04-11 | 3015967359-2023-00711 | Malfunction | Available | exact di |
| 2023-03-21 | 3015967359-2023-00578 | Malfunction | Available | exact di |
| 2022-07-31 | 3015967359-2022-01570 | Malfunction | Available | exact di |
| 2022-06-10 | 3015967359-2022-01139 | Malfunction | Available | exact di |
| 2022-05-20 | 3015967359-2022-01039 | Malfunction | Available | exact di |
Showing 1–15 of 110
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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