Reported Jan 17, 2018 · Terminated
Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product…
Edwards Lifesciences, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 12050 S Lone Peak Pkwy · Draper, UT · 84020-9414
Is this the product you have?
- Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A
- Product UsageThe Edwards Certitude Delivery System is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve (THV), typically during a transapical (TA) or transaortic (TAo) approach to transcatheter aortic valve replacement
- Lot codes and dates
- Lot Numbers
1,808 of 1,808 codes
606776536070335660703356607333696089885960708907607089076069331160677343606780336070890760699067606850576071298260760615607928346077698760813952607820836079643660840392608428076085496560885861609304436067727060678035606780406070335560704423607033556070442360679106606891056071800660718007607928386081395160782088608166136081661460842808608428106087349260842809608858626088586360930444606973336070335760703357606780076073966360733367607333666076082260801453608083136077698860816615
- Lot Numbers
- Amount recalled
- 1730 units
Where it was sold
Why it was recalled
Stop using this product now
A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient.
Using this product could cause serious injury, illness or death — stop using it now.
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