BEUDAMED
    FDA Recall Open, Classified

    LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TANDEMLIFE KIT - V24, A17

    Recall: Z-2465-2023 · Initiated June 30, 2023

    Recall

    Recall Number
    Z-2465-2023
    Event Number
    92748
    Firm
    Cardiac Assist, Inc
    FEI Number
    3002228812
    Product Code
    KFM
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 30, 2023
    Posted
    August 25, 2023
    Address
    240 Alpha Dr, Pittsburgh, PA, 15238-2906

    Description

    LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TANDEMLIFE KIT - V24, A17

    Reason

    Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,

    Action

    LivaNova - TandemLife made Initial contact by phone/email on June 30,2023 to ensure the affected pumps were quarantined and not used. Other details of the recall, including how the customer is to respond, are included in the customer letter issued July 14, 2023 provided via regular mail and/or email. Letter states reason for recall, health risk and action taken. For questions regarding this Medical Device Removal, please contact your TandemLife representative, or TandemLife Customer Quality at [email protected].

    Distribution

    US Nationwide distribution in the states of IL, FL.

    Quantity

    2 units