BEUDAMED
    FDA Enforcement Class II Terminated

    Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.

    Recall: Z-1134-2013 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1134-2013
    Event ID
    64747
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Edwards Lifesciences, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2013
    Initiation Date
    March 26, 2013
    Classification Date
    April 17, 2013
    Termination Date
    September 16, 2013
    Address
    12050 Lone Peak Pkwy, N/A, Draper, UT, 84020-9414, United States

    Description

    Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.

    Reason

    Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers.

    Code Info

    Models 9100CR23, all lot numbers.

    Distribution

    Nationwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.

    Quantity

    5,472 units