BEUDAMED
    FDA Recall 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 · Initiated December 17, 2019

    Recall

    Recall Number
    Z-2052-2020
    Event Number
    85434
    Firm
    W L Gore & Associates, Inc.
    FEI Number
    2017233
    Product Code
    MIH
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    December 17, 2019
    Posted
    May 20, 2020
    Terminated
    April 28, 2021
    Address
    1500 N 4th St, Flagstaff, AZ, 86004-5866

    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.

    Action

    On 12/17/2019, the firm's field representatives hand delivered an URGENT MEDICAL DEVICE RECALL Notification to customers informing them of a label issue with their stents. Two (2) of the 20 units in their work order are labeled with the incorrect part number and size on both the package and carton labels. Customers are instructed to: return the affected products for replacement and If customers have any questions or concern to contact Field Sales Associates for assistance at Telephone number: 03-6746-2560, FAX number: 03-6746-2561

    Distribution

    International the country of Japan.

    Quantity

    15 stents