BEUDAMED
    FDA Enforcement Class II Terminated

    GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)

    Recall: Z-0996-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-0996-2020
    Event ID
    84533
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    W. L. Gore & Associates Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2020
    Initiation Date
    January 6, 2020
    Classification Date
    February 4, 2020
    Termination Date
    August 9, 2022
    Address
    32360 N North Valley Pkwy, N/A, Phoenix, AZ, 85085-4228, United States

    Description

    GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)

    Reason

    Firm has received reports of leading end catheter component separations.

    Code Info

    -Catalog numbers PLC*, PLA*, PLL*, RLT23*, RLT26*, RLT28*, RLT31*, RLT35*, HGB*, and CEB* *= size -not specific to any particular lot or serial numbers. For full details of affected products see 806 Attachment 1 - Catalog Numbers and Sizes.

    Distribution

    US: OUS: Australia; Austria; Canada; China; Taiwan; United Arab Emirates; Argentina; Brazil; Switzerland; Chile; Colombia; Costa Rica; Czechia; Spain; Greece; Croatia; Hungary; Ireland; Israel; Italy; United Kingdom; Lebanon; Mexico; New Zealand; Panama; Poland; Saudi Arabia; Slovenia; Germany; Netherlands; Norway; Finland; France; Sweden; Monaco;

    Quantity

    23212 units