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.
2 linked reportsInjury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 27 |
| 2019-02 | 0 | 12 |
| 2019-03 | 0 | 24 |
| 2019-04 | 0 | 6 |
| 2019-05 | 0 | 12 |
| 2019-06 | 0 | 9 |
| 2019-07 | 0 | 6.5 |
| 2019-10 | 0 | 9 |
| 2019-11 | 0 | 15.33 |
| 2019-12 | 0 | 3.67 |
| 2020-02 | 0 | 2 |
| 2020-03 | 0 | 1 |
| 2020-04 | 0 | 3 |
| 2020-06 | 0 | 1 |
| 2020-07 | 0 | 3 |
| 2020-09 | 0 | 2 |
| 2020-10 | 0 | 1 |
| 2020-11 | 0 | 1 |
| 2020-12 | 0 | 2 |
| 2021-02 | 0 | 1 |
| 2021-03 | 0 | 6 |
| 2021-04 | 0 | 3 |
| 2021-06 | 0 | 3 |
| 2021-08 | 0 | 3 |
| 2021-09 | 0 | 2 |
| 2021-10 | 0 | 2 |
| 2021-11 | 0 | 3 |
| 2022-01 | 0 | 9 |
| 2022-03 | 0 | 2 |
| 2022-04 | 0 | 3 |
| 2022-05 | 0 | 3 |
| 2022-06 | 0 | 3 |
| 2022-08 | 0 | 1 |
| 2022-09 | 0 | 3 |
| 2022-10 | 0 | 6 |
| 2023-02 | 0 | 1 |
| 2023-03 | 0 | 3.5 |
| 2023-04 | 0 | 2 |
| 2023-08 | 0 | 3 |
| 2023-10 | 0 | 2 |
| 2023-12 | 0 | 3 |
| 2024-02 | 0 | 3 |
| 2024-03 | 0 | 6 |
| 2024-05 | 0 | 3 |
| 2024-07 | 0 | 1.5 |
| 2024-09 | 0 | 1.67 |
| 2024-10 | 0 | 2 |
| 2024-12 | 0 | 2 |
| 2025-01 | 0 | 3 |
| 2025-02 | 0 | 3 |
| 2025-03 | 0 | 3 |
| 2025-10 | 0 | 3 |
| 2025-12 | 0 | 2 |
| 2026-04 | 2 | 2.5 |
| 2026-05 | 0 | 6 |
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-04-13 | 1037905-2026-00174 | Injury | Available | exact di |
| 2026-04-13 | 1037905-2026-00175 | Injury | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-06-04 | VAI | Voluntary action indicated | Cook Incorporated | 6 |
| 2025-06-04 | VAI | Voluntary action indicated | Cook Incorporated | 6 |
| 2024-05-08 | VAI | Voluntary action indicated | Cook Incorporated | 1 |
| 2024-05-08 | VAI | Voluntary action indicated | Cook Incorporated | 1 |
| 2021-09-14 | VAI | Voluntary action indicated | Cook Incorporated | 2 |
| 2021-09-14 | VAI | Voluntary action indicated | Cook Incorporated | 2 |
| 2020-02-07 | VAI | Voluntary action indicated | Cook Incorporated | 4 |
| 2020-02-07 | VAI | Voluntary action indicated | Cook Incorporated | 4 |
| 2018-06-14 | VAI | Voluntary action indicated | Cook Incorporated | 1 |
| 2018-06-14 | VAI | Voluntary action indicated | Cook Incorporated | 1 |
| 2017-05-26 | VAI | Voluntary action indicated | Cook Incorporated | 3 |
| 2017-05-26 | VAI | Voluntary action indicated | Cook Incorporated | 3 |
| 2017-01-26 | VAI | Voluntary action indicated | Cook Incorporated | 11 |
| 2017-01-26 | VAI | Voluntary action indicated | Cook Incorporated | 11 |
| 2016-06-17 | VAI | Voluntary action indicated | Cook Inc | 2 |
| 2016-06-17 | VAI | Voluntary action indicated | Cook Inc | 2 |
| 2016-03-31 | NAI | No action indicated | Cook Inc | 0 |
| 2016-03-31 | NAI | No action indicated | Cook Inc | 0 |
| 2015-03-13 | VAI | Voluntary action indicated | Cook Incorporated | 5 |
| 2015-03-13 | VAI | Voluntary action indicated | Cook Incorporated | 5 |
| 2014-09-16 | WL | Warning Letter | Cook Incorporated | — |
| 2014-09-16 | WL | Warning Letter | Cook Incorporated | — |
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