BEUDAMED
    FDA Enforcement Class II Ongoing

    WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.

    Recall: Z-0170-2023 · Reported November 9, 2022

    Enforcement

    Recall Number
    Z-0170-2023
    Event ID
    90966
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MICROVENTION INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 9, 2022
    Initiation Date
    September 21, 2022
    Classification Date
    November 2, 2022
    Address
    35 Enterprise, N/A, Aliso Viejo, CA, 92656, United States

    Description

    WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.

    Reason

    Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully inserted into the controller, which may result in the inability of the controller to properly detach the implant device, which could cause delays and excessive manipulation that may cause the implant to move and damage vessels

    Code Info

    REF/UDI/Lots: WDC-2/00842429103128/0000095683, 0000096284, 0000205967, 0000206629, 0000215962, 0000216862, 0000224074, 0000241662, 0000242343, 0000242345; Distributed in China: WDC/00842429113684/0000078840, 0000086571, 0000088347, 0000088349, 0000136477, 0000181460, 0000191147; Distribution in Japan: MV-WDC2/04987892122231/0000142172; 0000166445; 0000210109; 0000245337

    Distribution

    Worldwide - US Nationwide distribution in the states of MN, PA, NY, MI, FL, VA, TX, OH, CA, NE, MN, NC, LA, IL, TN, IN, UT, KS and the countries of Japan, China, Argentina, Australia, South Korea, Italy, UK.

    Quantity

    2018