BEUDAMED
    FDA Enforcement Class II Ongoing

    MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as a stent-assisted coiling (SAC) device providing support to the embolic coils used in the treatment of wide-necked aneurysms.

    Recall: Z-1121-2025 · Reported February 19, 2025

    Enforcement

    Recall Number
    Z-1121-2025
    Event ID
    96114
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MICROVENTION INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2025
    Initiation Date
    December 11, 2024
    Classification Date
    February 7, 2025
    Address
    35 Enterprise, Aliso Viejo, CA, 92656, United States

    Description

    MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as a stent-assisted coiling (SAC) device providing support to the embolic coils used in the treatment of wide-necked aneurysms.

    Reason

    Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.

    Code Info

    Lot number: 0000456768

    Distribution

    US: None OUS: China

    Quantity

    11 units