BEUDAMED
    FDA Enforcement Class I Terminated

    Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.

    Recall: Z-0986-2019 · Reported April 3, 2019

    Enforcement

    Recall Number
    Z-0986-2019
    Event ID
    82265
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Cardiovascular Us Sales, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    April 3, 2019
    Initiation Date
    February 8, 2019
    Classification Date
    March 28, 2019
    Termination Date
    May 14, 2020
    Address
    45 Barbour Pond Dr, N/A, Wayne, NJ, 07470-2094, United States

    Description

    Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.

    Reason

    Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled incorrectly, leading to the inadequate operation of the Emergency Drive.

    Code Info

    Affected serial numbers: 90420359, 90421204, 90421188, 90421279, 90421228, 90421761, 90420904, 90420231, 90420455, 90421304

    Distribution

    US Nationwide Distribution in the states of California, Florida, Illinois, Kentucky, Michigan, and New York.

    Quantity

    10