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.
1,010 linked reportsMalfunction 1,009Injury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 17 | 2.57 |
| 2019-02 | 11 | 3.34 |
| 2019-03 | 12 | 3.74 |
| 2019-04 | 24 | 3.75 |
| 2019-05 | 17 | 4.47 |
| 2019-06 | 30 | 4.34 |
| 2019-07 | 28 | 3.28 |
| 2019-08 | 13 | 4.2 |
| 2019-09 | 12 | 4.39 |
| 2019-10 | 21 | 3.55 |
| 2019-11 | 18 | 4.17 |
| 2019-12 | 44 | 5.23 |
| 2020-01 | 15 | 3.83 |
| 2020-02 | 34 | 3.67 |
| 2020-03 | 46 | 5.43 |
| 2020-04 | 5 | 3.18 |
| 2020-05 | 4 | 3.39 |
| 2020-06 | 12 | 4.09 |
| 2020-07 | 32 | 3.35 |
| 2020-08 | 5 | 3.7 |
| 2020-09 | 25 | 4.4 |
| 2020-10 | 39 | 3.63 |
| 2020-11 | 29 | 4.26 |
| 2020-12 | 20 | 4.09 |
| 2021-01 | 47 | 3.41 |
| 2021-02 | 36 | 4.44 |
| 2021-03 | 35 | 4.14 |
| 2021-04 | 26 | 3.52 |
| 2021-05 | 25 | 4.14 |
| 2021-06 | 22 | 3.6 |
| 2021-07 | 12 | 3.14 |
| 2021-08 | 5 | 3.47 |
| 2021-09 | 12 | 2.94 |
| 2021-10 | 23 | 2.63 |
| 2021-11 | 21 | 3.19 |
| 2021-12 | 11 | 3.45 |
| 2022-01 | 7 | 2.89 |
| 2022-02 | 11 | 3.3 |
| 2022-03 | 7 | 3.73 |
| 2022-04 | 10 | 2.83 |
| 2022-05 | 8 | 3.4 |
| 2022-06 | 8 | 4.17 |
| 2022-07 | 7 | 3.03 |
| 2022-08 | 2 | 3.61 |
| 2022-09 | 7 | 4.98 |
| 2022-10 | 11 | 3.59 |
| 2022-11 | 8 | 4.13 |
| 2022-12 | 13 | 4.95 |
| 2023-01 | 5 | 2.81 |
| 2023-02 | 8 | 3.85 |
| 2023-03 | 7 | 3.68 |
| 2023-04 | 5 | 2.81 |
| 2023-05 | 7 | 4.17 |
| 2023-06 | 10 | 3.98 |
| 2023-07 | 5 | 3.25 |
| 2023-08 | 3 | 3.57 |
| 2023-09 | 3 | 3.49 |
| 2023-10 | 7 | 2.42 |
| 2023-11 | 4 | 4.39 |
| 2023-12 | 1 | 3.49 |
| 2024-01 | 14 | 2.91 |
| 2024-02 | 10 | 4.27 |
| 2024-03 | 3 | 3.3 |
| 2024-04 | 3 | 3.03 |
| 2024-05 | 3 | 4.22 |
| 2024-06 | 1 | 4.45 |
| 2024-07 | 3 | 2.76 |
| 2024-08 | 1 | 2.79 |
| 2024-09 | 1 | 4.14 |
| 2024-10 | 4 | 3 |
| 2024-11 | 2 | 2.93 |
| 2024-12 | 0 | 2.89 |
| 2025-01 | 6 | 2.91 |
| 2025-02 | 0 | 3.61 |
| 2025-03 | 0 | 3.28 |
| 2025-04 | 2 | 2.08 |
| 2025-05 | 2 | 4.03 |
| 2025-06 | 0 | 3.53 |
| 2025-07 | 1 | 2.85 |
| 2025-08 | 0 | 2.92 |
| 2025-09 | 0 | 2.57 |
| 2025-10 | 2 | 2.56 |
| 2025-11 | 0 | 4.02 |
| 2025-12 | 0 | 3.39 |
| 2026-01 | 0 | 2.42 |
| 2026-02 | 0 | 2.96 |
| 2026-03 | 0 | 3.04 |
| 2026-04 | 0 | 3.55 |
| 2026-05 | 0 | 3.26 |
| 2026-06 | 0 | 2.64 |
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 |
|---|---|---|---|---|
| 2025-10-23 | 3015967359-2025-99379 | Malfunction | Available | exact di |
| 2025-10-23 | 3015967359-2025-99378 | Malfunction | Available | exact di |
| 2025-07-29 | 3015967359-2025-99208 | Malfunction | Available | exact di |
| 2025-05-21 | 3015967359-2025-01030 | Malfunction | Available | exact di |
| 2025-05-21 | 3015967359-2025-01031 | Malfunction | Available | exact di |
| 2025-04-21 | 3015967359-2025-00846 | Malfunction | Available | exact di |
| 2025-04-02 | 3015967359-2025-00592 | Malfunction | Available | exact di |
| 2025-01-30 | 3015967359-2025-00372 | Malfunction | Available | exact di |
| 2025-01-30 | 3015967359-2025-00371 | Malfunction | Available | exact di |
| 2025-01-21 | 3015967359-2025-00162 | Malfunction | Available | exact di |
| 2025-01-21 | 3015967359-2025-00064 | Malfunction | Available | exact di |
| 2025-01-21 | 3015967359-2025-00237 | Malfunction | Available | exact di |
| 2025-01-06 | 3015967359-2025-00014 | Malfunction | Available | exact di |
| 2024-11-20 | 3015967359-2024-02346 | Malfunction | Available | exact di |
| 2024-11-07 | 3015967359-2024-02318 | Malfunction | Available | exact di |
Showing the most recent 200 of 1,010 linked reports.
Showing 1–15 of 200
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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