BEUDAMED
    FDA Recall Terminated

    Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.

    Recall: Z-1135-2013 · Initiated March 26, 2013

    Recall

    Recall Number
    Z-1135-2013
    Event Number
    64747
    Firm
    Edwards Lifesciences, LLC
    FEI Number
    1713910
    Product Code
    NPT
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    March 26, 2013
    Posted
    April 17, 2013
    Terminated
    September 16, 2013
    Address
    12050 Lone Peak Pkwy, Draper, UT, 84020-9414

    Description

    Edwards Lifesciences Crimpers, Model 9100CR26. 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.

    Action

    Edwards Lifesciences notified customers via letter and instructed them to maintain the device in its protective unit carton until ready for use and to inspect the pouch for holes or tears prior to use as instructed in the product's labeling. If any holes or tears are found, customers are instructed to contact Edwards Customer Service to arrange for return and replacement of damaged product.

    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

    6,117 units