BEUDAMED
    FDA Recall Terminated

    Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

    Recall: Z-1882-2019 · Initiated May 21, 2019

    Recall

    Recall Number
    Z-1882-2019
    Event Number
    83038
    Firm
    Medtronic Inc
    FEI Number
    3001504994
    Product Code
    DYE
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    May 21, 2019
    Posted
    June 26, 2019
    Terminated
    October 7, 2020
    Address
    710 Medtronic Pkwy, Mailstop Ls245, Minneapolis, MN, 55432-5603

    Description

    Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - 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.

    Action

    The firm initiated the recall by telephone on 05/21/2019 and followed with a letter disseminated on 06/05/2019 which requested that the consignee quarantine any unused affected product and return it to Medtronic.

    Distribution

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

    Quantity

    5 units