BEUDAMED
    FDA Enforcement Class II 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 · Reported November 13, 2019

    Enforcement

    Recall Number
    Z-0345-2020
    Event ID
    84025
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abiomed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    November 13, 2019
    Initiation Date
    September 4, 2019
    Classification Date
    November 7, 2019
    Termination Date
    January 21, 2020
    Address
    22 Cherry Hill Dr, N/A, Danvers, MA, 01923-2575, United States

    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.

    Code Info

    UDI: (01)00813502011371(10)1430951(17)210331(21)192148A; Serial Number: 192148A

    Distribution

    The product was distributed to GA

    Quantity

    1