BEUDAMED
    FDA Enforcement Class II Terminated

    TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.

    Recall: Z-1950-2020 · Reported May 20, 2020

    Enforcement

    Recall Number
    Z-1950-2020
    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: TandemHeart Kit - TS62/A17, Product: 5710-6217 - 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: S/N 00142612 00142614 00142657 00142658 00142659 00142660 00142661 00142663 00142937 00142938 00142941 00142942 00142970 00142971 00142972

    Distribution

    US Nationwide distributions.

    Quantity

    15