BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1533-2020 · Reported April 1, 2020

    Enforcement

    Recall Number
    Z-1533-2020
    Event ID
    85092
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MEDTRONIC ATS MEDICAL, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 1, 2020
    Initiation Date
    February 11, 2020
    Classification Date
    March 20, 2020
    Termination Date
    March 4, 2022
    Address
    3800 Annapolis Ln N, N/A, Plymouth, MN, 55447-5439, United States

    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.

    Code Info

    UDI 00643169297913, Serial Numbers: 935603, 935732

    Distribution

    China

    Quantity

    2 devices