BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0293-2018 · Initiated July 21, 2017

    Recall

    Recall Number
    Z-0293-2018
    Event Number
    78738
    Firm
    Edwards Lifesciences, LLC
    FEI Number
    1713910
    Product Code
    NPT
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    July 21, 2017
    Posted
    January 10, 2018
    Terminated
    September 13, 2019
    Address
    12050 S Lone Peak Pkwy, Draper, UT, 84020-9414

    Description

    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.

    Reason

    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.

    Action

    Recall notification letters were sent to affected consignees via Fed-Ex on 7/21/2017.

    Distribution

    United States: All states with the exception of: Alaska, Hawaii, Idaho, New Mexico, Rhode Island, South Dakota and Wyoming

    Quantity

    1730 units