BEUDAMED
    FDA Enforcement Class II Ongoing

    Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489

    Recall: Z-2340-2021 · Reported September 1, 2021

    Enforcement

    Recall Number
    Z-2340-2021
    Event ID
    88331
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    W. L. Gore & Associates Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 1, 2021
    Initiation Date
    July 12, 2021
    Classification Date
    August 25, 2021
    Address
    32360 N North Valley Pkwy, N/A, Phoenix, AZ, 85085-4228, United States

    Description

    Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489

    Reason

    Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or an inability to inflate.

    Code Info

    Serial Numbers between 22982051 - 23516741

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of AUS, CAN, CHE, DEU, DNK, ESP, FIN, FRA, GBR, GRC, HRV, HUN, IRL, ISR, ITA, JPN, MEX, NLD, NOR, POL, PRT, SMR, SWE.

    Quantity

    3,364 units