BEUDAMED
    FDA Enforcement Class II Ongoing

    GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

    Recall: Z-0291-2021 · Reported November 4, 2020

    Enforcement

    Recall Number
    Z-0291-2021
    Event ID
    86421
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    W L Gore & Associates, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 4, 2020
    Initiation Date
    September 9, 2020
    Classification Date
    October 23, 2020
    Address
    3750 W Kiltie Ln, N/A, Flagstaff, AZ, 86005-8712, United States

    Description

    GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

    Reason

    When the delivery catheter was attempted to be removed, there was an observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.

    Code Info

    CATALOG NUMBERS TGM212110X* TGM212115X* TGM212120X* TGM262610X* TGM262615X* TGM262620X* TGM282810X* TGM282815X* TGM282820X* TGM313110X* TGM313115X* TGM313120X* TGM343410X* TGM343415X* TGM343420X* TGM373710X* TGM373715X* TGM373720X* TGM404010X* TGM404015X* TGM404020X* TGM454510X* TGM454515X* TGM454520X* TGM262110X* TGM312610X* TGMR313110X* TGMR313115X* TGMR313120X* TGMR312610X* TGMR373710X* TGMR373715X* TGMR373720X* TGMR404010X* TGMR404015X* TGMR404020X* *X is a placeholder for enumeration code: E=EMEA, Australia, New Zealand; J=Japan All Lot Numbers

    Distribution

    U.S. - Nationwide O.U.S. - Australia, Austria, Belgium, Croatia, Cypress, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Monaco, Netherlands, Norway, New Zealand, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom

    Quantity

    19013 units