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.
82 linked reportsMalfunction 81Injury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 4 | 7.08 |
| 2019-02 | 0 | 3.45 |
| 2019-03 | 0 | 3.23 |
| 2019-04 | 1 | 3.53 |
| 2019-05 | 1 | 3.07 |
| 2019-06 | 0 | 3.61 |
| 2019-07 | 0 | 2.74 |
| 2019-08 | 1 | 3.03 |
| 2019-09 | 0 | 3.21 |
| 2019-10 | 0 | 3.53 |
| 2019-11 | 0 | 3.04 |
| 2019-12 | 1 | 3.15 |
| 2020-01 | 0 | 3.46 |
| 2020-02 | 5 | 3.59 |
| 2020-03 | 1 | 3.32 |
| 2020-04 | 3 | 3.38 |
| 2020-05 | 1 | 2.77 |
| 2020-06 | 1 | 3.77 |
| 2020-07 | 2 | 3.67 |
| 2020-08 | 0 | 4.8 |
| 2020-09 | 0 | 5.62 |
| 2020-10 | 1 | 5.6 |
| 2020-11 | 1 | 5.07 |
| 2020-12 | 4 | 5.81 |
| 2021-01 | 1 | 4.82 |
| 2021-02 | 2 | 4.61 |
| 2021-03 | 2 | 6.05 |
| 2021-04 | 5 | 5.29 |
| 2021-05 | 0 | 4.67 |
| 2021-06 | 0 | 4.79 |
| 2021-07 | 2 | 4.25 |
| 2021-08 | 1 | 4.26 |
| 2021-09 | 1 | 3.76 |
| 2021-10 | 1 | 4.35 |
| 2021-11 | 1 | 3.58 |
| 2021-12 | 2 | 4.74 |
| 2022-01 | 0 | 4.68 |
| 2022-02 | 1 | 4.66 |
| 2022-03 | 1 | 5.12 |
| 2022-04 | 1 | 5.69 |
| 2022-05 | 2 | 5.08 |
| 2022-06 | 1 | 5.46 |
| 2022-07 | 0 | 5.77 |
| 2022-08 | 0 | 5.72 |
| 2022-09 | 1 | 5.05 |
| 2022-10 | 1 | 5.01 |
| 2022-11 | 2 | 5.22 |
| 2022-12 | 5 | 5.62 |
| 2023-01 | 0 | 5.56 |
| 2023-02 | 0 | 4.73 |
| 2023-03 | 4 | 5.68 |
| 2023-04 | 2 | 5.29 |
| 2023-05 | 3 | 5.59 |
| 2023-06 | 2 | 6.21 |
| 2023-07 | 0 | 5.47 |
| 2023-08 | 2 | 5.94 |
| 2023-09 | 1 | 5.58 |
| 2023-10 | 2 | 5.75 |
| 2023-11 | 0 | 6.37 |
| 2023-12 | 3 | 6.93 |
| 2024-01 | 1 | 5.76 |
| 2024-02 | 1 | 6.29 |
| 2024-03 | 0 | 5.47 |
| 2024-04 | 0 | 6.21 |
| 2024-05 | 0 | 6.22 |
| 2024-06 | 0 | 7.63 |
| 2024-07 | 0 | 5.51 |
| 2024-08 | 0 | 6.04 |
| 2024-09 | 0 | 5.78 |
| 2024-10 | 1 | 6.83 |
| 2024-11 | 0 | 4.76 |
| 2024-12 | 0 | 5.69 |
| 2025-01 | 0 | 5.65 |
| 2025-02 | 0 | 4.71 |
| 2025-03 | 0 | 5.14 |
| 2025-04 | 0 | 4.89 |
| 2025-05 | 0 | 5.07 |
| 2025-06 | 0 | 4.75 |
| 2025-07 | 0 | 4.87 |
| 2025-08 | 0 | 5.09 |
| 2025-09 | 0 | 4.18 |
| 2025-10 | 0 | 4.75 |
| 2025-11 | 0 | 5.1 |
| 2025-12 | 0 | 6.08 |
| 2026-01 | 0 | 5.11 |
| 2026-02 | 0 | 5.21 |
| 2026-03 | 0 | 5.71 |
| 2026-04 | 0 | 6.43 |
| 2026-05 | 0 | 5.5 |
| 2026-06 | 0 | 4.97 |
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 |
|---|---|---|---|---|
| 2024-10-30 | 0002936485-2024-00728 | Malfunction | Available | exact di |
| 2024-02-14 | 0002936485-2024-00129 | Malfunction | Available | exact di |
| 2024-01-17 | 0002936485-2024-00044 | Malfunction | Available | exact di |
| 2023-12-22 | 0002936485-2023-01332 | Malfunction | Available | exact di |
| 2023-12-21 | 0002936485-2023-01325 | Malfunction | Available | exact di |
| 2023-12-13 | 0002936485-2023-01245 | Malfunction | Available | exact di |
| 2023-10-26 | 0002936485-2023-01079 | Malfunction | Available | exact di |
| 2023-10-19 | 0002936485-2023-01062 | Malfunction | Available | exact di |
| 2023-09-13 | 0002936485-2023-00935 | Malfunction | Available | exact di |
| 2023-08-18 | 0002936485-2023-00841 | Malfunction | Available | exact di |
| 2023-08-17 | 0002936485-2023-00827 | Malfunction | Available | exact di |
| 2023-06-21 | 0002936485-2023-00604 | Malfunction | Available | exact di |
| 2023-06-19 | 0002936485-2023-00600 | Malfunction | Available | exact di |
| 2023-05-16 | 0002936485-2023-00461 | Malfunction | Available | exact di |
| 2023-05-10 | 0002936485-2023-00417 | Malfunction | Available | exact di |
Showing 1–15 of 82
Regulatory clearances
- 510(k)K160332Substantially equivalent (SESE) · 2016-05-18clearance family
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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