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.
- United StatesArndt00827002441200
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.
4 linked reportsMalfunction 4
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-04 | 1 | — |
| 2019-05 | 1 | — |
| 2026-01 | 1 | — |
| 2026-06 | 1 | — |
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-30 | 1820334-2026-00697 | Malfunction | — | exact di |
| 2026-01-14 | 1820334-2026-00042 | Malfunction | Available | exact di |
| 2019-05-16 | 1820334-2019-01231 | Malfunction | Available | exact di |
| 2019-04-09 | 1820334-2019-00886 | 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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