BEUDAMED
    FDA Recall Terminated

    Cardiosave Hybrid and rescue IABP

    Recall: Z-1248-2016 · Initiated December 16, 2015

    Recall

    Recall Number
    Z-1248-2016
    Event Number
    72890
    Firm
    Maquet Datascope Corp Cardiac Assist Division
    FEI Number
    3001418283
    Product Code
    DSP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 16, 2015
    Terminated
    June 1, 2018
    Address
    1300 MacArthur Blvd., Mahwah, NJ, 07430-2052

    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.

    Action

    Maquet sent an "Urgent - Medical Device Field Correction Notice and Response form dated December 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are informed of the issues and provided corrective actions. Customers are asked to completed the attached response form in order to return to 1-973-629-1518, or via email to [email protected]. Questions can be directed 1-800-777-4222, option 3, Monday through Friday 8 am-6 pm. EST.

    Distribution

    Worldwide Distribution- Nationwide Distribution including Puerto Rico.

    Quantity

    1243 units US; 1107 units OUS