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.
78 linked reportsMalfunction 61Injury 17
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.03 |
| 2019-02 | 0 | 1.58 |
| 2019-03 | 0 | 1.76 |
| 2019-04 | 0 | 2.29 |
| 2019-05 | 0 | 1.73 |
| 2019-06 | 0 | 1.74 |
| 2019-07 | 0 | 1.89 |
| 2019-08 | 0 | 1.84 |
| 2019-09 | 2 | 1.72 |
| 2019-10 | 0 | 1.63 |
| 2019-11 | 0 | 1.91 |
| 2019-12 | 0 | 2.26 |
| 2020-01 | 0 | 2.4 |
| 2020-02 | 3 | 1.49 |
| 2020-03 | 0 | 1.77 |
| 2020-04 | 3 | 1.93 |
| 2020-05 | 3 | 1.84 |
| 2020-06 | 0 | 2.03 |
| 2020-07 | 0 | 2.34 |
| 2020-08 | 3 | 2.44 |
| 2020-09 | 0 | 2.67 |
| 2020-10 | 0 | 2.1 |
| 2020-11 | 0 | 2.64 |
| 2020-12 | 0 | 2.38 |
| 2021-01 | 0 | 1.83 |
| 2021-02 | 0 | 2.18 |
| 2021-03 | 0 | 2.38 |
| 2021-04 | 3 | 2.74 |
| 2021-05 | 0 | 2.49 |
| 2021-06 | 0 | 2.14 |
| 2021-07 | 3 | 2.27 |
| 2021-08 | 0 | 2.01 |
| 2021-09 | 0 | 2.23 |
| 2021-10 | 0 | 2.05 |
| 2021-11 | 0 | 2.22 |
| 2021-12 | 3 | 2.29 |
| 2022-01 | 0 | 2.93 |
| 2022-02 | 0 | 2.15 |
| 2022-03 | 0 | 1.91 |
| 2022-04 | 9 | 2.05 |
| 2022-05 | 0 | 2.2 |
| 2022-06 | 0 | 2.26 |
| 2022-07 | 3 | 2.21 |
| 2022-08 | 0 | 2.42 |
| 2022-09 | 3 | 2.69 |
| 2022-10 | 0 | 2.96 |
| 2022-11 | 0 | 2.98 |
| 2022-12 | 0 | 4.53 |
| 2023-01 | 0 | 2.64 |
| 2023-02 | 0 | 2.76 |
| 2023-03 | 0 | 3.04 |
| 2023-04 | 3 | 2.92 |
| 2023-05 | 0 | 3.6 |
| 2023-06 | 3 | 2.93 |
| 2023-07 | 0 | 2.24 |
| 2023-08 | 2 | 2.22 |
| 2023-09 | 0 | 2.02 |
| 2023-10 | 0 | 2.26 |
| 2023-11 | 6 | 1.96 |
| 2023-12 | 0 | 2.59 |
| 2024-01 | 2 | 2.6 |
| 2024-02 | 4 | 1.91 |
| 2024-03 | 0 | 2.2 |
| 2024-04 | 2 | 2.19 |
| 2024-05 | 1 | 2.32 |
| 2024-06 | 0 | 2.56 |
| 2024-07 | 0 | 2.46 |
| 2024-08 | 0 | 2.16 |
| 2024-09 | 2 | 2 |
| 2024-10 | 2 | 2.25 |
| 2024-11 | 0 | 1.94 |
| 2024-12 | 2 | 2.77 |
| 2025-01 | 2 | 2.05 |
| 2025-02 | 3 | 2.22 |
| 2025-03 | 0 | 2.34 |
| 2025-04 | 0 | 2.32 |
| 2025-05 | 0 | 2.52 |
| 2025-06 | 0 | 1.87 |
| 2025-07 | 2 | 2.18 |
| 2025-08 | 0 | 2.28 |
| 2025-09 | 0 | 1.98 |
| 2025-10 | 0 | 2.35 |
| 2025-11 | 2 | 2.02 |
| 2025-12 | 0 | 2.6 |
| 2026-01 | 0 | 1.98 |
| 2026-02 | 0 | 2.19 |
| 2026-03 | 2 | 2.81 |
| 2026-04 | 0 | 2.22 |
| 2026-05 | 0 | 2.44 |
| 2026-06 | 0 | 2.2 |
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 |
|---|---|---|---|---|
| 2026-03-25 | 0008031020-2026-00480 | Malfunction | Available | catalog number |
| 2025-11-10 | 0008031020-2025-02052 | Malfunction | Available | catalog number |
| 2025-07-01 | 0008031020-2025-01038 | Injury | Available | catalog number |
| 2025-02-21 | 0008031020-2025-00353 | Malfunction | Available | catalog number |
| 2025-02-21 | 0008031020-2025-00348 | Malfunction | Available | catalog number |
| 2025-01-09 | 0008031020-2025-00042 | Malfunction | Available | catalog number |
| 2024-12-04 | 0008031020-2024-00636 | Malfunction | Available | catalog number |
| 2024-10-21 | 0008031020-2024-00605 | Malfunction | Available | catalog number |
| 2024-09-25 | 0008031020-2024-00499 | Malfunction | Available | catalog number |
| 2024-05-01 | 0008031020-2024-00189 | Malfunction | Available | catalog number |
| 2024-04-08 | 0008031020-2024-00153 | Malfunction | Available | catalog number |
| 2024-02-20 | 0008031020-2024-00109 | Malfunction | Available | catalog number |
| 2024-02-06 | 0008031020-2024-00062 | Malfunction | Available | catalog number |
| 2024-01-02 | 0008031020-2024-00001 | Malfunction | Available | catalog number |
| 2023-11-28 | 0008031020-2023-00409 | Injury | Available | catalog number |
Showing the most recent 33 of 78 linked reports.
Showing 1–15 of 33
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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