BEUDAMED
    FDA Recall Terminated

    TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.

    Recall: Z-1763-2022 · Initiated July 21, 2022

    Recall

    Recall Number
    Z-1763-2022
    Event Number
    90755
    Firm
    Cardiac Assist, Inc
    FEI Number
    3002228812
    Product Code
    DWA
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 21, 2022
    Posted
    September 23, 2022
    Terminated
    August 8, 2023
    Address
    240 Alpha Dr, Pittsburgh, PA, 15238-2906

    Description

    TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.

    Reason

    Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.

    Action

    On July 21, 2022, the recalling firm notified impacted customers through mailed letters. Customers were instructed to use Operations Manual revision 15 and to discard all previous revisions of the Operations Manuals.

    Distribution

    US Nationwide distribution.

    Quantity

    723 units (484 currently in field)