BEUDAMED
    FDA Enforcement Class II Ongoing

    GORE CARDIOFORM Septal Occluder, REF: GSX0030A

    Recall: Z-1048-2023 · Reported February 8, 2023

    Enforcement

    Recall Number
    Z-1048-2023
    Event ID
    91380
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    W L Gore & Associates, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 8, 2023
    Initiation Date
    December 14, 2022
    Classification Date
    February 1, 2023
    Address
    3750 W Kiltie Ln, N/A, Flagstaff, AZ, 86005-8712, United States

    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.

    Code Info

    UDI-DI/Serial Numbers: 00733132631032/25556388, 25556389, 25556390, 25556391, 25556392, 25556393, 25556394, 25556398, 25556399, 25556400, 25556401, 25556402, 25556403, 25556406

    Distribution

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

    Quantity

    14