BEUDAMED
    FDA Enforcement Class II Terminated

    Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

    Recall: Z-1883-2019 · Reported July 3, 2019

    Enforcement

    Recall Number
    Z-1883-2019
    Event ID
    83038
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 3, 2019
    Initiation Date
    May 21, 2019
    Classification Date
    June 26, 2019
    Termination Date
    October 7, 2020
    Address
    710 Medtronic Pkwy Mailstop Ls245, N/A, Minneapolis, MN, 55432-5603, United States

    Description

    Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

    Reason

    Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.

    Code Info

    GTIN: 00643169027077 Serial Numbers: B654768, B694390, B818699, B887929, B896723, B896730, B914146

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of TN, NY, NJ, and countries of France, Italy, Libya, Poland, Spain.

    Quantity

    7 units