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.
10 linked reportsMalfunction 8Injury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 3.37 |
| 2019-02 | 0 | 4.38 |
| 2019-03 | 0 | 4.15 |
| 2019-04 | 0 | 4.29 |
| 2019-05 | 0 | 3.84 |
| 2019-06 | 0 | 3.72 |
| 2019-07 | 0 | 4.41 |
| 2019-08 | 0 | 3.59 |
| 2019-09 | 0 | 4.32 |
| 2019-10 | 0 | 4.39 |
| 2019-11 | 1 | 3.67 |
| 2019-12 | 0 | 3.62 |
| 2020-01 | 0 | 2.86 |
| 2020-02 | 0 | 3.79 |
| 2020-03 | 0 | 3.74 |
| 2020-04 | 0 | 3.24 |
| 2020-05 | 1 | 2.57 |
| 2020-06 | 0 | 3.29 |
| 2020-07 | 0 | 5.71 |
| 2020-08 | 0 | 3.2 |
| 2020-09 | 0 | 4.62 |
| 2020-10 | 0 | 3.92 |
| 2020-11 | 0 | 3.26 |
| 2020-12 | 0 | 4.62 |
| 2021-01 | 0 | 2.95 |
| 2021-02 | 0 | 3.77 |
| 2021-03 | 1 | 4.07 |
| 2021-04 | 0 | 3.45 |
| 2021-05 | 0 | 3.44 |
| 2021-06 | 0 | 4.59 |
| 2021-07 | 1 | 4.18 |
| 2021-08 | 1 | 2.36 |
| 2021-09 | 0 | 3.25 |
| 2021-10 | 0 | 3.85 |
| 2021-11 | 0 | 3.3 |
| 2021-12 | 0 | 3.93 |
| 2022-01 | 0 | 3.67 |
| 2022-02 | 1 | 3.36 |
| 2022-03 | 0 | 3.33 |
| 2022-04 | 0 | 4.23 |
| 2022-05 | 0 | 3.17 |
| 2022-06 | 0 | 4.79 |
| 2022-07 | 1 | 2.49 |
| 2022-08 | 0 | 2.61 |
| 2022-09 | 0 | 2.91 |
| 2022-10 | 0 | 3.19 |
| 2022-11 | 0 | 3.08 |
| 2022-12 | 0 | 2.51 |
| 2023-01 | 0 | 2.77 |
| 2023-02 | 0 | 2.22 |
| 2023-03 | 0 | 2.52 |
| 2023-04 | 0 | 2.62 |
| 2023-05 | 0 | 2.72 |
| 2023-06 | 0 | 2.82 |
| 2023-07 | 0 | 2.67 |
| 2023-08 | 0 | 2.5 |
| 2023-09 | 0 | 3.04 |
| 2023-10 | 1 | 3.28 |
| 2023-11 | 0 | 2.96 |
| 2023-12 | 0 | 2.85 |
| 2024-01 | 0 | 3.78 |
| 2024-02 | 0 | 4.16 |
| 2024-03 | 0 | 3.61 |
| 2024-04 | 0 | 3.35 |
| 2024-05 | 0 | 3.53 |
| 2024-06 | 0 | 2.79 |
| 2024-07 | 1 | 2.68 |
| 2024-08 | 0 | 3.96 |
| 2024-09 | 0 | 3.45 |
| 2024-10 | 0 | 2.82 |
| 2024-11 | 0 | 4.42 |
| 2024-12 | 0 | 5.21 |
| 2025-01 | 0 | 2.68 |
| 2025-02 | 0 | 3.31 |
| 2025-03 | 0 | 2.8 |
| 2025-04 | 0 | 2.42 |
| 2025-05 | 0 | 5.34 |
| 2025-06 | 0 | 3.09 |
| 2025-07 | 0 | 3.17 |
| 2025-08 | 0 | 2.9 |
| 2025-09 | 0 | 4.47 |
| 2025-10 | 0 | 6.61 |
| 2025-11 | 0 | 4.13 |
| 2025-12 | 0 | 3.64 |
| 2026-01 | 0 | 3.62 |
| 2026-02 | 0 | 3.21 |
| 2026-03 | 0 | 4.48 |
| 2026-04 | 0 | 4.46 |
| 2026-05 | 1 | 8.03 |
| 2026-06 | 0 | 3.67 |
Failure-mode summaryAI-generated
10 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-11 | 1037905-2026-00224 | Malfunction | Available | exact di |
| 2024-07-26 | 1037905-2024-00413 | Malfunction | Available | exact di |
| 2023-10-16 | 1037905-2023-00507 | Malfunction | Available | exact di |
| 2022-07-18 | 1037905-2022-00394 | Malfunction | Available | exact di |
| 2022-02-09 | 1037905-2022-00047 | Malfunction | Available | exact di |
| 2021-08-30 | 1037905-2021-00457 | Injury | Available | exact di |
| 2021-07-14 | 1037905-2021-00309 | Injury | Available | exact di |
| 2021-03-25 | 1037905-2021-00131 | Malfunction | Available | exact di |
| 2020-05-15 | 1037905-2020-00211 | Malfunction | Available | exact di |
| 2019-11-18 | 1037905-2019-00705 | Malfunction | 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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