BEUDAMED
    FDA Recall Open, Classified

    GORE CARDIOFORM Septal Occluder, REF: GSX0030A

    Recall: Z-1048-2023 · Initiated December 14, 2022

    Recall

    Recall Number
    Z-1048-2023
    Event Number
    91380
    Firm
    W L Gore & Associates, Inc.
    FEI Number
    2017233
    Product Code
    MLV
    Status
    Open, Classified
    Root Cause
    Employee error
    Initiated
    December 14, 2022
    Posted
    February 1, 2023
    Address
    3750 W Kiltie Ln, Flagstaff, AZ, 86005-8712

    Description

    GORE CARDIOFORM Septal Occluder, REF: GSX0030A

    Reason

    Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could potentially result could result in occluder embolization, anoxic brain injury, central venous or arterial perforation or rupture.

    Action

    On 12/14/22, recall notices were mailed to customers informing them to take the following actions: 1) Identify and return any unused devices. 2) Complete and return the customer response form to to [email protected] 3) This notice needs to be shared with those who should be aware within your institution or to any organization where potentially affected devices have been transferred. Customers with questions can contact the firm at [email protected]

    Distribution

    US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA.

    Quantity

    14