BEUDAMED
    FDA Recall Terminated

    Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillinov-Cosgrove LAA Clip (Clip) is an implantable device used for occlusion of the left atrial appendage.

    Recall: Z-1209-2014 · Initiated January 23, 2014

    Recall

    Recall Number
    Z-1209-2014
    Event Number
    67572
    Firm
    Atricure Inc
    FEI Number
    3011706110
    Product Code
    HBT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 23, 2014
    Posted
    March 14, 2014
    Terminated
    May 13, 2014
    Address
    6217 Centre Park Drive West, Chester, OH, 45069

    Description

    Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillinov-Cosgrove LAA Clip (Clip) is an implantable device used for occlusion of the left atrial appendage.

    Reason

    The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.

    Action

    On 1/24/2014 the firm sent Urgent Recall Notification letters to their customers.

    Distribution

    Nationwide Distribution-including the states of AL, CA, CO, CT, DE, FL, KY, MD, MI, MN, MO, NC, NY, OH, OR, PA, TN, UT, VA & WA.

    Quantity

    46 units