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 StatesAcrobat00827002476158
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.
1 linked reportMalfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2026-03 | 1 | — |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-03-31 | 1037905-2026-00154 | Malfunction | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-10-24 | NAI | No action indicated | Wilson-Cook Medical Inc. | 0 |
| 2014-12-23 | VAI | Voluntary action indicated | Wilson-Cook Medical Inc. | 2 |
| 2012-03-06 | VAI | Voluntary action indicated | Wilson-Cook Medical Inc. | 6 |
| 2011-06-24 | WL | Warning Letter | Wilson-Cook Medical Inc. | — |
| 2011-04-19 | OAI | Official action indicated | Wilson-Cook Medical Inc. | 8 |
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