BEUDAMED
    FDA Enforcement Class II Terminated

    TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.

    Recall: Z-1952-2020 · Reported May 20, 2020

    Enforcement

    Recall Number
    Z-1952-2020
    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 - DL3, Product: 5720-3118 - 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: 00142562 00142563 00142564 00142565 00142566 00142567 00142568 00142583 00142585 00142587 00142588 00142589 00142602 00142603 00142604 00142607 00142610 00142611 00142653 00142655 00142684 00142685 00142686 00142687 00142688 00142689 00142690 00142701 00142702 00142703 00142704 00142705 00142706 00142927 00142928 00142953 00142954 00142955 00142956 00142957 00142958 00142959 00142962 00142964 00142966 00142967

    Distribution

    US Nationwide distributions.

    Quantity

    46