BEUDAMED
    FDA Recall Terminated

    Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm

    Recall: Z-1533-2020 · Initiated February 11, 2020

    Recall

    Recall Number
    Z-1533-2020
    Event Number
    85092
    Firm
    MEDTRONIC ATS MEDICAL, INC.
    FEI Number
    3008592544
    Product Code
    LWQ
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 11, 2020
    Terminated
    March 4, 2022
    Address
    3800 Annapolis Ln N, Plymouth, MN, 55447-5439

    Description

    Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm

    Reason

    Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. The valve itself was correctly labeled as Mitral.

    Action

    On 11-Feb-2020, a Medtronic field representative notified the 1 (one) consignee who had received affected product via telephone. The consignee was asked to quarantine and return the affected product.

    Distribution

    China

    Quantity

    2 devices