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.
16 linked reportsMalfunction 12Injury 4
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.42 |
| 2019-02 | 0 | 3.53 |
| 2019-03 | 1 | 2.95 |
| 2019-04 | 0 | 3.13 |
| 2019-05 | 1 | 2.46 |
| 2019-06 | 0 | 3.58 |
| 2019-07 | 0 | 2.42 |
| 2019-08 | 1 | 2.47 |
| 2019-09 | 0 | 2.47 |
| 2019-10 | 0 | 2.71 |
| 2019-11 | 2 | 2.12 |
| 2019-12 | 0 | 2.35 |
| 2020-01 | 0 | 2.55 |
| 2020-02 | 0 | 2.7 |
| 2020-03 | 0 | 2.28 |
| 2020-04 | 0 | 2.54 |
| 2020-05 | 0 | 1.98 |
| 2020-06 | 0 | 2.78 |
| 2020-07 | 0 | 2.77 |
| 2020-08 | 0 | 4.33 |
| 2020-09 | 0 | 4.4 |
| 2020-10 | 0 | 3.99 |
| 2020-11 | 0 | 4.47 |
| 2020-12 | 0 | 3.87 |
| 2021-01 | 0 | 3.99 |
| 2021-02 | 0 | 3.89 |
| 2021-03 | 0 | 4.83 |
| 2021-04 | 0 | 4.7 |
| 2021-05 | 0 | 4.05 |
| 2021-06 | 0 | 4.28 |
| 2021-07 | 0 | 3.88 |
| 2021-08 | 0 | 3.87 |
| 2021-09 | 1 | 3.91 |
| 2021-10 | 2 | 3.99 |
| 2021-11 | 0 | 3.49 |
| 2021-12 | 0 | 4.46 |
| 2022-01 | 0 | 4.57 |
| 2022-02 | 0 | 5.03 |
| 2022-03 | 0 | 5.45 |
| 2022-04 | 0 | 6.48 |
| 2022-05 | 0 | 5.46 |
| 2022-06 | 0 | 6.07 |
| 2022-07 | 0 | 6.34 |
| 2022-08 | 0 | 6.38 |
| 2022-09 | 1 | 5.53 |
| 2022-10 | 0 | 5.35 |
| 2022-11 | 1 | 5.52 |
| 2022-12 | 0 | 6 |
| 2023-01 | 0 | 5.73 |
| 2023-02 | 0 | 4.87 |
| 2023-03 | 0 | 5.86 |
| 2023-04 | 0 | 5.47 |
| 2023-05 | 0 | 5.86 |
| 2023-06 | 0 | 7.1 |
| 2023-07 | 0 | 6.1 |
| 2023-08 | 0 | 6.28 |
| 2023-09 | 0 | 5.92 |
| 2023-10 | 0 | 6.38 |
| 2023-11 | 0 | 5.76 |
| 2023-12 | 0 | 6.05 |
| 2024-01 | 0 | 5.53 |
| 2024-02 | 0 | 6.18 |
| 2024-03 | 0 | 5.56 |
| 2024-04 | 0 | 6.32 |
| 2024-05 | 0 | 5.3 |
| 2024-06 | 0 | 7.07 |
| 2024-07 | 0 | 5.75 |
| 2024-08 | 0 | 6.5 |
| 2024-09 | 0 | 6.28 |
| 2024-10 | 0 | 7.11 |
| 2024-11 | 0 | 4.55 |
| 2024-12 | 0 | 4.77 |
| 2025-01 | 0 | 4.42 |
| 2025-02 | 1 | 4.03 |
| 2025-03 | 0 | 5.17 |
| 2025-04 | 0 | 4.67 |
| 2025-05 | 0 | 4.69 |
| 2025-06 | 0 | 4.58 |
| 2025-07 | 0 | 4.68 |
| 2025-08 | 0 | 5.45 |
| 2025-09 | 0 | 3.97 |
| 2025-10 | 0 | 4.59 |
| 2025-11 | 0 | 4.86 |
| 2025-12 | 0 | 6.15 |
| 2026-01 | 0 | 4.95 |
| 2026-02 | 0 | 5.05 |
| 2026-03 | 2 | 5.77 |
| 2026-04 | 3 | 6.2 |
| 2026-05 | 0 | 5.86 |
| 2026-06 | 0 | 5.01 |
Failure-mode summaryAI-generated
16 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-04-16 | 0002936485-2026-00240 | Malfunction | Available | exact di |
| 2026-04-16 | 0002936485-2026-00235 | Malfunction | Available | exact di |
| 2026-04-06 | 0002936485-2026-00224 | Malfunction | Available | exact di |
| 2026-03-05 | 24518615 | Malfunction | Available | catalog number |
| 2025-02-12 | 0002936485-2025-00105 | Malfunction | Available | exact di |
| 2022-11-21 | 0002936485-2022-00694 | Malfunction | Available | exact di |
| 2022-09-24 | 0002936485-2022-00531 | Malfunction | Available | exact di |
| 2021-10-28 | 0002936485-2021-00582 | Injury | Available | exact di |
| 2021-10-27 | 0002936485-2021-00572 | Malfunction | Available | exact di |
| 2021-09-30 | 0002936485-2021-00521 | Malfunction | Available | exact di |
| 2019-11-27 | 0002936485-2019-00527 | Malfunction | Available | exact di |
| 2019-11-27 | 0002936485-2019-00526 | Malfunction | Available | exact di |
| 2019-08-29 | 0002936485-2019-00369 | Injury | Available | exact di |
| 2019-05-30 | 0002936485-2019-00224 | Injury | Available | exact di |
| 2019-03-19 | 0002936485-2019-00103 | Injury | Available | exact di |
Showing the most recent 15 of 16 linked reports.
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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