BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0927-2022 · Initiated March 2, 2022

    Recall

    Recall Number
    Z-0927-2022
    Event Number
    89754
    Firm
    Medtronic Inc
    FEI Number
    3001504994
    Product Code
    NPV
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 2, 2022
    Posted
    April 18, 2022
    Address
    710 Medtronic Pkwy, Mailstop Ls245, Minneapolis, MN, 55432-5603

    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.

    Action

    Beginning 02-MAR-2022 Medtronic initiated communications of an Urgent Medical Device Notice letter via 2-day UPS delivery to consignees who have received affected product according to Medtronic records. Consignees are asked to review the Medtronic Urgent Medical Device Notice notification and follow the Recommended Actions. Implanting physicians associated with related valves to the Harmony DCS were included in notifications, though these valve products are not subject to the recall issue. Additional verbal communication was initiated for a full product recall on March 24. Written communications were mailed on April 5, 2022 stating that Medtronic is recommending an immediate suspension of the Harmony DCS product use and is undertaking a voluntarily recall of the Harmony DCS.

    Distribution

    US Nationwide and the countries of Canada.

    Quantity

    1483 devices