BEUDAMED
    FDA Enforcement Class II Terminated

    Cardiosave Hybrid and rescue IABP

    Recall: Z-1248-2016 · Reported April 6, 2016

    Enforcement

    Recall Number
    Z-1248-2016
    Event ID
    72890
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Datascope Corp - Cardiac Assist Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 6, 2016
    Initiation Date
    December 16, 2015
    Classification Date
    March 25, 2016
    Termination Date
    June 1, 2018
    Address
    1300 MacArthur Blvd., N/A, Mahwah, NJ, 07430-2052, United States

    Description

    Cardiosave Hybrid and rescue IABP

    Reason

    Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.

    Code Info

    Cardiosave Hybrid IABP 0998-00-0800-53,0998-UC-0800-53, Cardiosave Rescue IABP 0998-00-0800-83 & 0998-UC-0800-83

    Distribution

    Worldwide Distribution- Nationwide Distribution including Puerto Rico.

    Quantity

    1243 units US; 1107 units OUS