BEUDAMED
    FDA Recall Terminated

    lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI

    Recall: Z-0345-2020 · Initiated September 4, 2019

    Recall

    Recall Number
    Z-0345-2020
    Event Number
    84025
    Firm
    Abiomed, Inc.
    FEI Number
    1220648
    Product Code
    OZD
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 4, 2019
    Terminated
    January 21, 2020
    Address
    22 Cherry Hill Dr, Danvers, MA, 01923-2575

    Description

    lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI

    Reason

    This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would have immediately run at P9 for all selected P-levels, rather than a 10 second ramp up period. The pump may have migrated out of position and possibly caused injury. The positioning and suction alarms were also disabled.

    Action

    The affected device was retrieved from the only customer on 9/4/19. An Urgent Medical Device Recall notification letter dated 9/12/19 was sent to that customer as well.

    Distribution

    The product was distributed to GA

    Quantity

    1