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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.

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.

5 linked reportsMalfunction 5
11222019-02: 1 reports for this device2019-03: 2 reports for this device2019-08: 1 reports for this device2019-10: 1 reports for this device02030810
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-021—
2019-032—
2019-081—
2019-101—
This device (reports/month)Average device in its product code (reports/device/month)
Failure-mode summaryAI-generated

5 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2019-10-181037905-2019-00615MalfunctionAvailableexact di
2019-08-201037905-2019-00480MalfunctionAvailableexact di
2019-03-041037905-2019-00110MalfunctionAvailableexact di
2019-03-041037905-2019-00102MalfunctionAvailableexact di
2019-02-181037905-2019-00069MalfunctionAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-10-24NAINo action indicatedWilson-Cook Medical Inc.0
2014-12-23VAIVoluntary action indicatedWilson-Cook Medical Inc.2
2012-03-06VAIVoluntary action indicatedWilson-Cook Medical Inc.6
2011-06-24WLWarning LetterWilson-Cook Medical Inc.—
2011-04-19OAIOfficial action indicatedWilson-Cook Medical Inc.8
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