BEUDAMED
    FDA Recall Terminated

    TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.

    Recall: Z-1949-2020 · Initiated March 6, 2020

    Recall

    Recall Number
    Z-1949-2020
    Event Number
    85322
    Firm
    Cardiac Assist, Inc
    FEI Number
    3002228812
    Product Code
    KFM
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 6, 2020
    Terminated
    November 20, 2020
    Address
    240 Alpha Dr, Pittsburgh, PA, 15238-2906

    Description

    TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - 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

    Action

    LivaNova dba Tandem Life notified consignees via 1st class mail (certified return receipt) on March 06th, 2020, states reason for recall, health risk, and action to take: Check your inventory for the presence of potentially affected TandemHeart pump contained within your ordered kit as per Table 1 provided in Attachment 1; - Ensure any affected kit containing the potentially affected TandemHeart pump still in inventory gets quarantined before they can be returned. 2. Please fill and return Response Form by email to [email protected] confirm appropriate corrective actions have been executed. Please return the Response Form even if each potentially affected device listed in Attachment 1 has already been used. 3. Potentially affected product still in your inventory will be replaced once the Response Form has been returned to LivaNova. Leverage your TandemLife representativeto aid in the collection of the affected quarantined kit containing the potentially affected TandemHeart pump. Questions regarding this Medical Device Removal, please contact your TandemLife representative, or TandemLife Customer Quality at [email protected].

    Distribution

    US Nationwide distributions.

    Quantity

    5