BEUDAMED
    FDA Enforcement Class III Terminated

    VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.

    Recall: Z-1829-2021 · Reported June 16, 2021

    Enforcement

    Recall Number
    Z-1829-2021
    Event ID
    88024
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    MICROVENTION INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 16, 2021
    Initiation Date
    April 21, 2021
    Classification Date
    June 7, 2021
    Termination Date
    February 16, 2024
    Address
    35 Enterprise, N/A, Aliso Viejo, CA, 92656, United States

    Description

    VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.

    Reason

    Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.

    Code Info

    Catalog Number: VIA-21-154-01 UDI: (01)00842429101650(11)191104(17)221031(10)19110403M Lot Number: 19110403M

    Distribution

    U.S. Nationwide distribution in the states of FL, IA, MI, MN, TN and TX.

    Quantity

    N/A