BEUDAMED
    FDA Recall Open, Classified

    LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/3.5 mm x 17 mm x 13 mm

    Recall: Z-2200-2026 · Initiated April 6, 2026

    Recall

    Recall Number
    Z-2200-2026
    Event Number
    98755
    Firm
    MICROVENTION INC.
    FEI Number
    3013556777
    Product Code
    QCA
    Status
    Open, Classified
    Root Cause
    Mixed-up of materials/components
    Initiated
    April 6, 2026
    Posted
    May 14, 2026
    Address
    35 Enterprise, Aliso Viejo, CA, 92656

    Description

    LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/3.5 mm x 17 mm x 13 mm

    Reason

    Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events

    Action

    On 4/6/2026, recall notices with TERUMO NEURO listed on notice top, were emailed to customers who were asked to do the following: 1) Stop using and quarantine affected devices. 2) Complete and return the acknowledgement form via email to -Distributors should provide the recall notice to medical facilities or users to whom you have distributed affected products. - Distributors should reconcile the completed forms from all customers and submit to recalling firm via email [email protected] If you have questions about this recall contact firm at [email protected]

    Distribution

    International distribution to the country of China.

    Quantity

    38