BEUDAMED
    FDA Enforcement Class II Ongoing

    Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:

    Recall: Z-0077-2022 · Reported October 20, 2021

    Enforcement

    Recall Number
    Z-0077-2022
    Event ID
    88721
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    W L Gore & Associates, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 20, 2021
    Initiation Date
    September 7, 2021
    Classification Date
    October 8, 2021
    Address
    3750 W Kiltie Ln, N/A, Flagstaff, AZ, 86005-8712, United States

    Description

    Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:

    Reason

    Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.

    Code Info

    Serial Numbers: 22753580

    Distribution

    International distribution to the countries of Italy & Lebanon.

    Quantity

    2 units