BEUDAMED
    FDA Enforcement Class II Terminated

    Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.

    Recall: Z-2052-2020 · Reported May 27, 2020

    Enforcement

    Recall Number
    Z-2052-2020
    Event ID
    85434
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    W L Gore & Associates, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    May 27, 2020
    Initiation Date
    December 17, 2019
    Classification Date
    May 20, 2020
    Termination Date
    April 28, 2021
    Address
    1500 N 4th St, N/A, Flagstaff, AZ, 86004-5866, United States

    Description

    Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.

    Reason

    The incorrect label was placed on both the primary and secondary package.

    Code Info

    Part number of the device is TGM343420J Serial numbers: 21225065 21225066 21225067 21225068 21225069 21225070 21225071 21225072 21225073 21225074 21225075 21225076 21225077 21225078 21225079 21225080 21225081 21225082 21225083 21225084

    Distribution

    International the country of Japan.

    Quantity

    15 stents