BEUDAMED
    FDA Enforcement Class II 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 · Reported March 26, 2014

    Enforcement

    Recall Number
    Z-1209-2014
    Event ID
    67572
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Atricure Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 26, 2014
    Initiation Date
    January 23, 2014
    Classification Date
    March 14, 2014
    Termination Date
    May 13, 2014
    Address
    6217 Centre Park Drive, West Chester, OH, 45069, United States

    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.

    Code Info

    Lot Number MFR-0424-1

    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