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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.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2024-08-07Z-3261-2024Class IIOpen, ClassifiedProducts expire prior to the expiration date printed on the product labelingDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, South Africa, United Kingdom.120 unitscode info di
Regulatory clearances
  • 510(k)K142887Substantially equivalent (SESE) · 2015-10-01clearance family

Predicate lineage

K062697

Cited as predicate by: K130547, K133011, K133306, K140306, K142887

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2015-09-25VAIVoluntary action indicatedCook Biotech, Inc.3
2015-09-25VAIVoluntary action indicatedCook Biotech, Inc.3
2013-07-16VAIVoluntary action indicatedCook Biotech, Inc.1
2013-07-16VAIVoluntary action indicatedCook Biotech, Inc.1
2010-10-05NAINo action indicatedCook Biotech, Inc.0
2010-10-05NAINo action indicatedCook Biotech, Inc.0
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