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.
9 linked reportsMalfunction 9
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1 |
| 2019-03 | 0 | 1 |
| 2019-04 | 0 | 2 |
| 2019-05 | 0 | 2 |
| 2019-06 | 0 | 1.67 |
| 2019-07 | 0 | 1.5 |
| 2019-08 | 1 | 1.5 |
| 2019-09 | 0 | 1 |
| 2019-10 | 0 | 2.75 |
| 2019-11 | 0 | 2.5 |
| 2019-12 | 0 | 5 |
| 2020-01 | 0 | 1.67 |
| 2020-02 | 0 | 2.5 |
| 2020-03 | 0 | 1.67 |
| 2020-04 | 0 | 1 |
| 2020-05 | 0 | 1.5 |
| 2020-06 | 0 | 4 |
| 2020-07 | 0 | 2.17 |
| 2020-08 | 1 | 2.2 |
| 2020-09 | 0 | 2.6 |
| 2020-10 | 0 | 3.33 |
| 2020-11 | 0 | 2 |
| 2020-12 | 0 | 2.33 |
| 2021-01 | 0 | 3.4 |
| 2021-02 | 0 | 2 |
| 2021-03 | 0 | 3.43 |
| 2021-04 | 0 | 5.4 |
| 2021-05 | 1 | 2.88 |
| 2021-06 | 0 | 2.88 |
| 2021-07 | 0 | 3.29 |
| 2021-08 | 0 | 3.38 |
| 2021-09 | 0 | 4.25 |
| 2021-10 | 0 | 3 |
| 2021-11 | 0 | 3.29 |
| 2021-12 | 1 | 6 |
| 2022-01 | 0 | 3.71 |
| 2022-02 | 0 | 8.4 |
| 2022-03 | 0 | 6.33 |
| 2022-04 | 1 | 5.83 |
| 2022-05 | 0 | 12.63 |
| 2022-06 | 0 | 10.83 |
| 2022-07 | 0 | 5.57 |
| 2022-08 | 0 | 4.4 |
| 2022-09 | 0 | 3.9 |
| 2022-10 | 0 | 4.38 |
| 2022-11 | 0 | 5.9 |
| 2022-12 | 1 | 4.75 |
| 2023-01 | 0 | 5.29 |
| 2023-02 | 1 | 4.63 |
| 2023-03 | 1 | 6.27 |
| 2023-04 | 0 | 7.25 |
| 2023-05 | 0 | 7.75 |
| 2023-06 | 0 | 4.7 |
| 2023-07 | 1 | 6.75 |
| 2023-08 | 0 | 8 |
| 2023-09 | 0 | 10.14 |
| 2023-10 | 0 | 7.44 |
| 2023-11 | 0 | 8.22 |
| 2023-12 | 0 | 8.88 |
| 2024-01 | 0 | 7.91 |
| 2024-02 | 0 | 15.86 |
| 2024-03 | 0 | 14 |
| 2024-04 | 0 | 11.11 |
| 2024-05 | 0 | 11.71 |
| 2024-06 | 0 | 18.83 |
| 2024-07 | 0 | 22.4 |
| 2024-08 | 0 | 13 |
| 2024-09 | 0 | 12.86 |
| 2024-10 | 0 | 13.71 |
| 2024-11 | 0 | 6.25 |
| 2024-12 | 0 | 9.67 |
| 2025-01 | 0 | 8 |
| 2025-02 | 0 | 3.63 |
| 2025-03 | 0 | 5.5 |
| 2025-04 | 0 | 4.33 |
| 2025-05 | 0 | 4.4 |
| 2025-06 | 0 | 5 |
| 2025-07 | 0 | 6.88 |
| 2025-08 | 0 | 4.8 |
| 2025-09 | 0 | 3.83 |
| 2025-10 | 0 | 4.23 |
| 2025-11 | 0 | 3.71 |
| 2025-12 | 0 | 4.79 |
| 2026-01 | 0 | 4.9 |
| 2026-02 | 0 | 3.5 |
| 2026-03 | 0 | 4 |
| 2026-04 | 0 | 6.21 |
| 2026-05 | 0 | 4.2 |
| 2026-06 | 0 | 3.87 |
Failure-mode summaryAI-generated
9 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2023-07-18 | 0002936485-2023-00695 | Malfunction | Available | exact di |
| 2023-03-24 | 0002936485-2023-00237 | Malfunction | Available | exact di |
| 2023-02-09 | 0002936485-2023-00107 | Malfunction | Available | exact di |
| 2022-12-21 | 0002936485-2022-00796 | Malfunction | Available | exact di |
| 2022-04-18 | 0002936485-2022-00182 | Malfunction | Available | exact di |
| 2021-12-20 | 0002936485-2021-00718 | Malfunction | Available | exact di |
| 2021-05-06 | 0002936485-2021-00244 | Malfunction | Available | exact di |
| 2020-08-12 | 0002936485-2020-00337 | Malfunction | Available | exact di |
| 2019-08-13 | 0002936485-2019-00337 | Malfunction | Available | exact di |
Regulatory clearances
- 510(k)K142310Substantially equivalent (SESE) · 2014-12-02clearance family
Predicate lineage
Cited as predicate by: K150956, K151243, K173866, K182160, K192292, K203550, K210088, K220108, K222079, K230886, K241401
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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