BEUDAMED
    FDA Enforcement Class II Terminated

    MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, REF MIA-9090S-IDE, For Investigational Use Only. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

    Recall: Z-2442-2021 · Reported September 15, 2021

    Enforcement

    Recall Number
    Z-2442-2021
    Event ID
    88408
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mivi Neuroscience Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 15, 2021
    Initiation Date
    July 23, 2021
    Classification Date
    September 9, 2021
    Termination Date
    May 23, 2024
    Address
    6545 City West Pkwy, N/A, Eden Prairie, MN, 55344-3248, United States

    Description

    MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, REF MIA-9090S-IDE, For Investigational Use Only. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

    Reason

    There is potential for nonsterility of product due to a possible defect in the pouch seal.

    Code Info

    Cat #MIA-9095S-IDE - Lots M20120006, exp. 9/10/2021; and M21030007, exp. 9/10/2021. Cat. #MIA-9090S-IDE - Lot M21030006, exp. 12/10/2021, and M21010009, exp. 12/10/2021.

    Distribution

    US Distribution to states of: FL, MA, NJ, NY, and TN; and OUS (Foreign) distribution to countries of: France, Hungary, Slovenia, and Spain.

    Quantity

    68 units