BEUDAMED
    FDA Enforcement Class II Terminated

    AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.

    Recall: Z-0377-2017 · Reported November 16, 2016

    Enforcement

    Recall Number
    Z-0377-2017
    Event ID
    75178
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AtriCure, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 16, 2016
    Initiation Date
    September 22, 2016
    Classification Date
    November 9, 2016
    Termination Date
    February 15, 2018
    Address
    7555 Innovation Way, Mason, OH, 45040-9695, United States

    Description

    AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.

    Reason

    There is a potential for a component failure of the device which could necessitate medical intervention.

    Code Info

    Model Numbers: PRO235, PRO240, PRO245 and PRO250 Lot Numbers: 65622 to 66773

    Distribution

    Nationwide Distribution to the follwoing states: AL, AR, AZ, CA, CT, FL, GA, IL, KS, MD, MI, MN, MO, MS, NC, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT & WI. Product was also shipped to the following countries: Poland and Switzerland

    Quantity

    298