BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated December 11, 2024

    Recall

    Recall Number
    Z-1121-2025
    Event Number
    96114
    Firm
    MICROVENTION INC.
    FEI Number
    3013556777
    Product Code
    QCA
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 11, 2024
    Posted
    February 7, 2025
    Address
    35 Enterprise, Aliso Viejo, CA, 92656

    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.

    Action

    On December 11, 2024, MicroVention Europe SARL aka Terumo Neuro issued a "Urgent Medical Device Recall" Notification to affected consignees via mail. Terumo Neuro asked consignees to take the following actions: 1. Review Inventory; 2. Inform and Forward Recall Notice; 3. Return Product; 4. Please complete and return the "Customer Acknowledgment Form"; 4. Contact Quality Department ; 5. Replacement or Credit of Returned Devices

    Distribution

    US: None OUS: China

    Quantity

    11 units