FDA-Device2018-01-17Class I
Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The 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.
Edwards Lifesciences, LLC
Hazard
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.
Sold states
United States: All states with the exception of: Alaska, Hawaii, Idaho, New Mexico, Rhode Island, South Dakota and Wyoming
Affected count
1730 units
Manufactured in
12050 S Lone Peak Pkwy, N/A, Draper, UT, United States
Products
Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0293-2018Don't want to check this manually?
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