Regulatory presence across jurisdictions
The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
- European UnionArndtB-00827002441095
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.
40 linked reportsMalfunction 38Injury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1 |
| 2019-04 | 0 | 1.5 |
| 2019-05 | 0 | 1.5 |
| 2019-06 | 0 | 2 |
| 2019-07 | 1 | 1 |
| 2019-08 | 0 | 1.4 |
| 2019-10 | 0 | 1.5 |
| 2019-11 | 0 | 2 |
| 2019-12 | 0 | 1 |
| 2020-01 | 0 | 1.17 |
| 2020-04 | 0 | 1 |
| 2020-05 | 0 | 1.5 |
| 2020-06 | 0 | 1 |
| 2020-07 | 0 | 1 |
| 2020-08 | 0 | 1 |
| 2020-11 | 0 | 2 |
| 2020-12 | 1 | 1 |
| 2021-01 | 0 | 1.29 |
| 2021-02 | 0 | 2.17 |
| 2021-03 | 1 | 1.17 |
| 2021-04 | 0 | 1 |
| 2021-05 | 0 | 2.8 |
| 2021-06 | 0 | 2.5 |
| 2021-07 | 0 | 1.5 |
| 2021-08 | 1 | 1.75 |
| 2021-09 | 0 | 4.2 |
| 2021-10 | 0 | 2.5 |
| 2021-11 | 0 | 3.14 |
| 2021-12 | 0 | 2.57 |
| 2022-01 | 0 | 1.5 |
| 2022-02 | 0 | 1.17 |
| 2022-03 | 0 | 2.29 |
| 2022-04 | 0 | 3.5 |
| 2022-05 | 0 | 3.5 |
| 2022-06 | 0 | 1.83 |
| 2022-07 | 0 | 2 |
| 2022-08 | 0 | 3.8 |
| 2022-09 | 0 | 2.13 |
| 2022-10 | 0 | 1.43 |
| 2022-11 | 0 | 1.5 |
| 2022-12 | 0 | 1 |
| 2023-01 | 0 | 2.67 |
| 2023-02 | 0 | 1 |
| 2023-03 | 0 | 5 |
| 2023-04 | 0 | 1.67 |
| 2023-05 | 0 | 2 |
| 2023-06 | 0 | 2 |
| 2023-07 | 0 | 1.2 |
| 2023-08 | 0 | 2.33 |
| 2023-09 | 0 | 1.4 |
| 2023-10 | 0 | 1.22 |
| 2023-11 | 0 | 5.67 |
| 2023-12 | 3 | 2 |
| 2024-01 | 0 | 1.6 |
| 2024-02 | 0 | 1.33 |
| 2024-03 | 0 | 1.25 |
| 2024-04 | 0 | 1.44 |
| 2024-05 | 2 | 1.6 |
| 2024-07 | 0 | 1 |
| 2024-08 | 0 | 2.43 |
| 2024-09 | 0 | 1.22 |
| 2024-10 | 0 | 2.13 |
| 2024-11 | 2 | 1.77 |
| 2024-12 | 0 | 4.75 |
| 2025-01 | 2 | 1.5 |
| 2025-02 | 3 | 1.67 |
| 2025-03 | 6 | 7 |
| 2025-04 | 9 | 5.4 |
| 2025-05 | 0 | 1.4 |
| 2025-06 | 0 | 2.86 |
| 2025-07 | 0 | 3.38 |
| 2025-08 | 0 | 1 |
| 2025-09 | 0 | 1.33 |
| 2025-10 | 0 | 1.67 |
| 2025-11 | 3 | 1.56 |
| 2025-12 | 3 | 2.29 |
| 2026-01 | 0 | 3 |
| 2026-02 | 0 | 5.25 |
| 2026-03 | 0 | 1 |
| 2026-04 | 0 | 1 |
| 2026-05 | 3 | 3 |
| 2026-06 | 0 | 3 |
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 |
|---|---|---|---|---|
| 2026-05-15 | 1820334-2026-00517 | Malfunction | Available | catalog number |
| 2025-12-01 | 1820334-2025-01480 | Malfunction | Available | catalog number |
| 2025-11-17 | 1820334-2025-01419 | Malfunction | Available | catalog number |
| 2025-04-22 | 1820334-2025-00429 | Malfunction | Available | catalog number |
| 2025-04-08 | 1820334-2025-00358 | Malfunction | Available | catalog number |
| 2025-04-08 | 1820334-2025-00360 | Malfunction | Available | catalog number |
| 2025-04-08 | 1820334-2025-00359 | Malfunction | Available | catalog number |
| 2025-03-25 | 1820334-2025-00286 | Malfunction | Available | catalog number |
| 2025-03-25 | 1820334-2025-00287 | Malfunction | Available | catalog number |
| 2025-02-26 | 1820334-2025-00188 | Malfunction | Available | catalog number |
| 2025-01-23 | 1820334-2025-00106 | Malfunction | Available | catalog number |
| 2024-11-15 | 1820334-2024-01493 | Malfunction | Available | catalog number |
| 2024-05-16 | 1820334-2024-00680 | Malfunction | Available | catalog number |
| 2023-12-18 | 1820334-2023-01721 | Malfunction | Available | catalog number |
| 2023-12-15 | 1820334-2023-01703 | Malfunction | Available | catalog number |
Showing the most recent 19 of 40 linked reports.
Showing 1–15 of 19
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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