BEUDAMED
    FDA Recall Terminated

    GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignant strictures in the biliary tree.

    Recall: Z-1593-2021 · Initiated April 5, 2021

    Recall

    Recall Number
    Z-1593-2021
    Event Number
    87699
    Firm
    W.L. Gore & Associates, Inc.
    FEI Number
    3003910212
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    April 5, 2021
    Terminated
    January 16, 2024
    Address
    301 Airport Rd, Elkton, MD, 21921-4130

    Description

    GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignant strictures in the biliary tree.

    Reason

    The Gore post market surveillance team received a complaint that a GORE VIABIL Biliary Endoprosthesis appeared shorter than the labeled length.

    Action

    On 04/08/2021, Gore issued an Urgent Medical Device Removal notice to customer via letter notifying them that a Gore Viabil Biliary Endoprosthesis 10 mm x 10 cm device appeared shorter than the labeled length.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, HI, IL, KS, MD, MN, NE, NY, OK, RI, TX, VA and the countries of Portugal, Italy.

    Quantity

    61 devices