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.
1 linked reportMalfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 4.5 |
| 2019-02 | 0 | 3.14 |
| 2019-03 | 0 | 5.87 |
| 2019-04 | 0 | 11.87 |
| 2019-05 | 0 | 3.97 |
| 2019-06 | 0 | 4.12 |
| 2019-07 | 0 | 6.7 |
| 2019-08 | 0 | 3.4 |
| 2019-09 | 0 | 2.86 |
| 2019-10 | 0 | 3.49 |
| 2019-11 | 0 | 4 |
| 2019-12 | 0 | 3.65 |
| 2020-01 | 0 | 3.39 |
| 2020-02 | 0 | 5.44 |
| 2020-03 | 0 | 3.55 |
| 2020-04 | 0 | 3.4 |
| 2020-05 | 0 | 4.49 |
| 2020-06 | 0 | 4.36 |
| 2020-07 | 0 | 6.85 |
| 2020-08 | 0 | 5.55 |
| 2020-09 | 0 | 5.05 |
| 2020-10 | 0 | 6.8 |
| 2020-11 | 0 | 7 |
| 2020-12 | 0 | 8.74 |
| 2021-01 | 0 | 8.68 |
| 2021-02 | 0 | 8.57 |
| 2021-03 | 0 | 10.88 |
| 2021-04 | 0 | 9.6 |
| 2021-05 | 0 | 9.26 |
| 2021-06 | 0 | 8.77 |
| 2021-07 | 0 | 9.1 |
| 2021-08 | 0 | 8.89 |
| 2021-09 | 0 | 11.35 |
| 2021-10 | 0 | 8.64 |
| 2021-11 | 0 | 9.26 |
| 2021-12 | 0 | 10.97 |
| 2022-01 | 0 | 9.42 |
| 2022-02 | 0 | 10.12 |
| 2022-03 | 0 | 13.33 |
| 2022-04 | 0 | 12.59 |
| 2022-05 | 0 | 12.74 |
| 2022-06 | 0 | 12.09 |
| 2022-07 | 0 | 10.07 |
| 2022-08 | 0 | 9.83 |
| 2022-09 | 0 | 8.46 |
| 2022-10 | 0 | 9.28 |
| 2022-11 | 0 | 9.36 |
| 2022-12 | 0 | 10.41 |
| 2023-01 | 0 | 11.88 |
| 2023-02 | 0 | 9.73 |
| 2023-03 | 0 | 12.19 |
| 2023-04 | 0 | 11.57 |
| 2023-05 | 0 | 12.13 |
| 2023-06 | 0 | 10.55 |
| 2023-07 | 0 | 9.89 |
| 2023-08 | 0 | 11.25 |
| 2023-09 | 0 | 10.45 |
| 2023-10 | 0 | 11.54 |
| 2023-11 | 0 | 11.32 |
| 2023-12 | 0 | 11.22 |
| 2024-01 | 0 | 11.8 |
| 2024-02 | 0 | 12.93 |
| 2024-03 | 0 | 14.13 |
| 2024-04 | 0 | 11.98 |
| 2024-05 | 0 | 10.99 |
| 2024-06 | 0 | 12.22 |
| 2024-07 | 0 | 12.33 |
| 2024-08 | 0 | 11.81 |
| 2024-09 | 0 | 12.39 |
| 2024-10 | 0 | 14.82 |
| 2024-11 | 0 | 9.49 |
| 2024-12 | 0 | 8.16 |
| 2025-01 | 0 | 8.39 |
| 2025-02 | 0 | 8.37 |
| 2025-03 | 0 | 8.27 |
| 2025-04 | 0 | 8.96 |
| 2025-05 | 0 | 8.68 |
| 2025-06 | 0 | 8.72 |
| 2025-07 | 0 | 8.99 |
| 2025-08 | 0 | 9.89 |
| 2025-09 | 0 | 7.96 |
| 2025-10 | 0 | 14.57 |
| 2025-11 | 0 | 17.27 |
| 2025-12 | 0 | 27.94 |
| 2026-01 | 1 | 25.46 |
| 2026-02 | 0 | 17.04 |
| 2026-03 | 0 | 13.47 |
| 2026-04 | 0 | 21.39 |
| 2026-05 | 0 | 21.65 |
| 2026-06 | 0 | 21.59 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-01-07 | 0002936485-2026-00005 | Malfunction | Available | exact di |
Regulatory clearances
- 510(k)K233635Substantially equivalent (SESE) · 2024-02-12clearance 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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