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.
40 linked reportsMalfunction 29Injury 11
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 3 | 6.09 |
| 2019-02 | 0 | 5.59 |
| 2019-03 | 3 | 6.19 |
| 2019-04 | 0 | 7.81 |
| 2019-05 | 1 | 6.19 |
| 2019-06 | 0 | 4 |
| 2019-07 | 0 | 6.26 |
| 2019-08 | 0 | 7.14 |
| 2019-09 | 1 | 8.45 |
| 2019-10 | 0 | 6.87 |
| 2019-11 | 0 | 8.74 |
| 2019-12 | 1 | 7.84 |
| 2020-01 | 1 | 7.88 |
| 2020-02 | 1 | 5.09 |
| 2020-03 | 3 | 11.85 |
| 2020-04 | 1 | 10.61 |
| 2020-05 | 0 | 8.36 |
| 2020-06 | 1 | 6.16 |
| 2020-07 | 2 | 7.48 |
| 2020-08 | 2 | 8.52 |
| 2020-09 | 0 | 7.38 |
| 2020-10 | 0 | 10 |
| 2020-11 | 1 | 11.68 |
| 2020-12 | 1 | 11.65 |
| 2021-01 | 1 | 15.59 |
| 2021-02 | 2 | 13.16 |
| 2021-03 | 0 | 9.9 |
| 2021-04 | 0 | 11.75 |
| 2021-05 | 0 | 9.33 |
| 2021-06 | 2 | 7.84 |
| 2021-07 | 2 | 12.05 |
| 2021-08 | 3 | 9.17 |
| 2021-09 | 0 | 9.29 |
| 2021-10 | 0 | 11.68 |
| 2021-11 | 3 | 9.78 |
| 2021-12 | 0 | 10 |
| 2022-01 | 0 | 7.76 |
| 2022-02 | 3 | 11.54 |
| 2022-03 | 0 | 10.67 |
| 2022-04 | 0 | 6.19 |
| 2022-05 | 1 | 8.31 |
| 2022-06 | 1 | 7.57 |
| 2022-07 | 0 | 6.16 |
| 2022-08 | 0 | 8.39 |
| 2022-09 | 0 | 6.64 |
| 2022-10 | 0 | 8.06 |
| 2022-11 | 0 | 11.06 |
| 2022-12 | 0 | 8.96 |
| 2023-01 | 0 | 11.86 |
| 2023-02 | 0 | 12.58 |
| 2023-03 | 0 | 14.73 |
| 2023-04 | 0 | 14.78 |
| 2023-05 | 0 | 13.18 |
| 2023-06 | 0 | 16.77 |
| 2023-07 | 0 | 17.81 |
| 2023-08 | 0 | 20.46 |
| 2023-09 | 0 | 13.43 |
| 2023-10 | 0 | 16.51 |
| 2023-11 | 0 | 9.24 |
| 2023-12 | 0 | 15.57 |
| 2024-01 | 0 | 10.25 |
| 2024-02 | 0 | 16.66 |
| 2024-03 | 0 | 40.35 |
| 2024-04 | 0 | 61.7 |
| 2024-05 | 0 | 72.31 |
| 2024-06 | 0 | 69.97 |
| 2024-07 | 0 | 55.17 |
| 2024-08 | 0 | 32.98 |
| 2024-09 | 0 | 28.96 |
| 2024-10 | 0 | 17.14 |
| 2024-11 | 0 | 15.37 |
| 2024-12 | 0 | 10.96 |
| 2025-01 | 0 | 8.77 |
| 2025-02 | 0 | 7.59 |
| 2025-03 | 0 | 7.76 |
| 2025-04 | 0 | 10.04 |
| 2025-05 | 0 | 12.83 |
| 2025-06 | 0 | 13.22 |
| 2025-07 | 0 | 7.86 |
| 2025-08 | 0 | 7.7 |
| 2025-09 | 0 | 7 |
| 2025-10 | 0 | 7.05 |
| 2025-11 | 0 | 16.97 |
| 2025-12 | 0 | 8.75 |
| 2026-01 | 0 | 8.62 |
| 2026-02 | 0 | 18.97 |
| 2026-03 | 0 | 8.78 |
| 2026-04 | 0 | 11.63 |
| 2026-05 | 0 | 11.57 |
| 2026-06 | 0 | 14.08 |
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 |
|---|---|---|---|---|
| 2022-06-16 | 0002936485-2022-00338 | Injury | Available | exact di |
| 2022-05-11 | 0002936485-2022-00225 | Malfunction | Available | exact di |
| 2022-02-23 | 0002936485-2022-00100 | Malfunction | Available | exact di |
| 2022-02-01 | 0002936485-2022-00061 | Malfunction | Available | exact di |
| 2022-02-01 | 0002936485-2022-00062 | Injury | Available | exact di |
| 2021-11-22 | 0002936485-2021-00664 | Malfunction | Available | exact di |
| 2021-11-22 | 0002936485-2021-00665 | Injury | Available | exact di |
| 2021-11-17 | 0002936485-2021-00634 | Malfunction | Available | exact di |
| 2021-08-19 | 0002936485-2021-00446 | Malfunction | Available | exact di |
| 2021-08-18 | 0002936485-2021-00440 | Injury | Available | exact di |
| 2021-08-02 | 0002936485-2021-00405 | Malfunction | Available | exact di |
| 2021-07-19 | 0002936485-2021-00391 | Malfunction | Available | exact di |
| 2021-07-19 | 0002936485-2021-00390 | Malfunction | Available | exact di |
| 2021-06-15 | 0002936485-2021-00317 | Malfunction | Available | exact di |
| 2021-06-02 | 0002936485-2021-00283 | Malfunction | Available | exact di |
Showing 1–15 of 40
Regulatory clearances
- 510(k)K153087Substantially equivalent (SESE) · 2016-07-14clearance family
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
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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