BEUDAMED
    FDA Enforcement Class I Ongoing

    Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.

    Recall: Z-0927-2022 · Reported April 27, 2022

    Enforcement

    Recall Number
    Z-0927-2022
    Event ID
    89754
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 27, 2022
    Initiation Date
    March 2, 2022
    Classification Date
    April 18, 2022
    Address
    710 Medtronic Pkwy Mailstop Ls245, Minneapolis, MN, 55432-5603, United States

    Description

    Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.

    Reason

    There is potential for the capsule bond to break during the procedure.

    Code Info

    HARMONY-DCS (GTIN: 00763000341367); Lot Numbers: 0010519040, 0010565921, 0010578123, 0010578126, 0010583884, 0010631963, 0010631969, 0010631971, 0010717000, 0010717001, 0010717002, 0010723188, 0010723189, 0010723190, 0010727345, 0010804938, 0010826589, (the following lots were added 4/22/2022) 0010826591, 0010826592, and 0010826593

    Distribution

    US Nationwide and the countries of Canada.

    Quantity

    1483 devices