BEUDAMED
    FDA Recall Terminated

    Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB

    Recall: Z-2429-2021 · Initiated July 21, 2021

    Recall

    Recall Number
    Z-2429-2021
    Event Number
    88372
    Firm
    Cordis Corporation
    FEI Number
    1016427
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 21, 2021
    Posted
    September 15, 2021
    Terminated
    September 9, 2024
    Address
    14201 NW 60th Ave, Miami Lakes, FL, 33014-2802

    Description

    Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB

    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.

    Action

    The firm disseminated an Urgent Medical Device Field Correction notice beginning on 07/21/2021. The letter described the problem and provided recommendations for clinical use found in the instructions for use.

    Distribution

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

    Quantity

    1610 units