BEUDAMED
    FDA Enforcement Class I Terminated

    Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C

    Recall: Z-2432-2021 · Reported September 22, 2021

    Enforcement

    Recall Number
    Z-2432-2021
    Event ID
    88372
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cordis Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 22, 2021
    Initiation Date
    July 21, 2021
    Classification Date
    September 15, 2021
    Termination Date
    September 9, 2024
    Address
    14201 NW 60th Ave, N/A, Miami Lakes, FL, 33014-2802, United States

    Description

    Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C

    Reason

    Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or dislodgement.

    Code Info

    all codes

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.

    Quantity

    26025 units