BEUDAMED
    FDA Enforcement Class II Terminated

    TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.

    Recall: Z-1951-2020 · Reported May 20, 2020

    Enforcement

    Recall Number
    Z-1951-2020
    Event ID
    85322
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardiac Assist, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2020
    Initiation Date
    March 6, 2020
    Classification Date
    May 11, 2020
    Termination Date
    November 20, 2020
    Address
    240 Alpha Dr, N/A, Pittsburgh, PA, 15238-2906, United States

    Description

    TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.

    Reason

    Failure to prime due to an assembly error

    Code Info

    Serial Numbers: 00142569 00142570 00142571 00142572 00142573 00142574 00142575 00142576 00142592 00142593 00142594 00142595 00142597 00142598 00142600 00142601 00142664 00142665 00142666 00142668 00142669 00142670 00142671 00142672 00142673 00142674 00142692 00142693 00142694 00142696 00142697 00142698 00142699 00142926 00142930 00142933 00142936 00142934

    Distribution

    US Nationwide distributions.

    Quantity

    38