BEUDAMED
    FDA Recall Terminated

    Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.

    Recall: Z-0535-2018 · Initiated January 3, 2018

    Recall

    Recall Number
    Z-0535-2018
    Event Number
    78977
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    January 3, 2018
    Posted
    January 30, 2018
    Terminated
    October 5, 2020
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.

    Reason

    Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.

    Action

    In response to an Urgent Safety Alert issued by Terumo Cardiovascular Systems (CVS) Medtronic initiated their safety alert verbally to their direct consignees on 10/23/2017, providing them with a copy of the Terumo Safety Alert dated 06/27/2017. The firm followed this action with a letter on 1/3/18 in which they stated that the action by Terumo CVS was changed to a recall, and , in response, Medtronic was following up as a recall and requested the products be returned.

    Distribution

    DE, IA, CA and Japan

    Quantity

    2914 units