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.
138 linked reportsMalfunction 136Injury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.33 |
| 2019-02 | 0 | 1.53 |
| 2019-03 | 0 | 2.33 |
| 2019-04 | 0 | 2.14 |
| 2019-05 | 0 | 2.28 |
| 2019-06 | 0 | 2.4 |
| 2019-07 | 1 | 1.92 |
| 2019-08 | 0 | 2.5 |
| 2019-09 | 0 | 3.42 |
| 2019-10 | 0 | 2.26 |
| 2019-11 | 0 | 1.86 |
| 2019-12 | 0 | 2.2 |
| 2020-01 | 0 | 3.07 |
| 2020-02 | 0 | 2.29 |
| 2020-03 | 1 | 2.4 |
| 2020-04 | 0 | 1.75 |
| 2020-05 | 0 | 1.67 |
| 2020-06 | 0 | 2.95 |
| 2020-07 | 0 | 2.33 |
| 2020-08 | 0 | 2.7 |
| 2020-09 | 0 | 2.59 |
| 2020-10 | 0 | 2.84 |
| 2020-11 | 0 | 2.83 |
| 2020-12 | 0 | 2.62 |
| 2021-01 | 0 | 3.19 |
| 2021-02 | 1 | 2.67 |
| 2021-03 | 0 | 2.87 |
| 2021-04 | 1 | 3.2 |
| 2021-05 | 0 | 2.67 |
| 2021-06 | 0 | 2.46 |
| 2021-07 | 1 | 2.4 |
| 2021-08 | 1 | 2.05 |
| 2021-09 | 0 | 2.9 |
| 2021-10 | 0 | 2.62 |
| 2021-11 | 0 | 2.63 |
| 2021-12 | 0 | 2 |
| 2022-01 | 0 | 2.63 |
| 2022-02 | 0 | 1.65 |
| 2022-03 | 1 | 2.41 |
| 2022-04 | 0 | 2.59 |
| 2022-05 | 0 | 2.73 |
| 2022-06 | 0 | 1.89 |
| 2022-07 | 0 | 2.29 |
| 2022-08 | 0 | 2.4 |
| 2022-09 | 0 | 2.17 |
| 2022-10 | 1 | 2.47 |
| 2022-11 | 1 | 2.32 |
| 2022-12 | 3 | 3.59 |
| 2023-01 | 0 | 2.25 |
| 2023-02 | 1 | 3.1 |
| 2023-03 | 1 | 2.81 |
| 2023-04 | 0 | 2 |
| 2023-05 | 10 | 4.46 |
| 2023-06 | 18 | 3.52 |
| 2023-07 | 11 | 3.38 |
| 2023-08 | 5 | 2.3 |
| 2023-09 | 12 | 3.46 |
| 2023-10 | 11 | 2.64 |
| 2023-11 | 20 | 3.76 |
| 2023-12 | 12 | 3.56 |
| 2024-01 | 4 | 2.48 |
| 2024-02 | 1 | 2.73 |
| 2024-03 | 5 | 2.95 |
| 2024-04 | 0 | 2.32 |
| 2024-05 | 2 | 4.15 |
| 2024-06 | 0 | 5.53 |
| 2024-07 | 2 | 3.14 |
| 2024-08 | 0 | 2.3 |
| 2024-09 | 0 | 2.76 |
| 2024-10 | 0 | 2.61 |
| 2024-11 | 0 | 2.5 |
| 2024-12 | 0 | 2.7 |
| 2025-01 | 0 | 3.35 |
| 2025-02 | 0 | 3.62 |
| 2025-03 | 0 | 3.11 |
| 2025-04 | 1 | 3 |
| 2025-05 | 0 | 3 |
| 2025-06 | 0 | 2.44 |
| 2025-07 | 1 | 2.88 |
| 2025-08 | 0 | 2.84 |
| 2025-09 | 0 | 1.89 |
| 2025-10 | 1 | 3 |
| 2025-11 | 1 | 2.94 |
| 2025-12 | 3 | 3.71 |
| 2026-01 | 2 | 2.45 |
| 2026-02 | 2 | 3.21 |
| 2026-03 | 0 | 2.39 |
| 2026-04 | 0 | 2.57 |
| 2026-05 | 0 | 3.8 |
| 2026-06 | 0 | 2.86 |
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 |
|---|---|---|---|---|
| 2026-02-24 | 0002936485-2026-00116 | Malfunction | Available | exact di |
| 2026-02-06 | 0002936485-2026-00069 | Malfunction | Available | exact di |
| 2026-01-09 | 0002936485-2026-00014 | Malfunction | Available | exact di |
| 2026-01-07 | 0002936485-2026-00001 | Malfunction | Available | exact di |
| 2025-12-17 | 0002936485-2025-00992 | Malfunction | Available | exact di |
| 2025-12-16 | 0002936485-2025-00988 | Malfunction | Available | exact di |
| 2025-12-11 | 0002936485-2025-00978 | Malfunction | Available | exact di |
| 2025-11-26 | 0002936485-2025-00943 | Malfunction | Available | exact di |
| 2025-10-23 | 0002936485-2025-00871 | Malfunction | Available | exact di |
| 2025-07-15 | 0002936485-2025-00641 | Malfunction | Available | exact di |
| 2025-04-07 | 0002936485-2025-00308 | Malfunction | Available | exact di |
| 2024-07-23 | 0002936485-2024-00515 | Malfunction | Available | exact di |
| 2024-07-12 | 0002936485-2024-00508 | Malfunction | Available | exact di |
| 2024-05-24 | 0002936485-2024-00423 | Malfunction | Available | exact di |
| 2024-05-23 | 0002936485-2024-00422 | Malfunction | Available | exact di |
Showing 1–15 of 138
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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