BEUDAMED
    FDA Enforcement Class II Terminated

    Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.

    Recall: Z-0918-2014 · Reported February 12, 2014

    Enforcement

    Recall Number
    Z-0918-2014
    Event ID
    67362
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Edwards Lifesciences, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2014
    Initiation Date
    January 20, 2014
    Classification Date
    February 3, 2014
    Termination Date
    March 24, 2014
    Address
    12050 Lone Peak Pkwy, Draper, UT, 84020-9414, United States

    Description

    Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.

    Reason

    Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they may not open sufficiently when the handle is rotated in the full open position. As a result, user may have difficulty fitting a 26mm Sapien transcatheter heart valve into the crimper orifice when preparing the valve for crimping.

    Code Info

    lot 59617777 and 59658495.

    Distribution

    Nationwide Distribution

    Quantity

    422