BEUDAMED
    FDA Recall Open, Classified

    MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32

    Recall: Z-1462-2023 · Initiated April 4, 2023

    Recall

    Recall Number
    Z-1462-2023
    Event Number
    92021
    Firm
    Datascope Corp.
    FEI Number
    3001418283
    Product Code
    DSP
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    April 4, 2023
    Posted
    April 26, 2023
    Address
    1300 Macarthur Blvd, Mahwah, NJ, 07430-2052

    Description

    MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32

    Reason

    The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle.

    Action

    An URGENT FIELD SAFETY NOTICE MEDICAL DEVICE CORRECTION was sent to customers beginning 4/4/23. Actions to be taken by the Customer now: Our records indicate that that you have received one or more CARDIOSAVE hybrid IABPs having the serial numbers that are affected by this recall. 1. Inspect the IABP to determine if it has a Type J power plug (refer to Image 1 below). If present, the IABP should not be used until the cord reel has been replaced. 2. Schedule a service appointment with your Datascope Corp./Getinge Service Representative for the cord reel correction from a Type J connector to Type N (refer to Image 2 below). 3. Please ensure that all Cardiosave Intra-Aortic Balloon Pump users at your hospital / facility are aware of this notice. 4. Please forward this information to all current and potential Cardiosave Hybrid IABP users within your hospital/facility. 5. If you are a distributor who has shipped any affected products to customers, please forward this letter to their attention for appropriate action. Actions to be taken: Please examine your inventory to determine you have a Cardiosave Hybrid IABP. Whether you have an affected cord or not, please complete and sign the attached RESPONSE FORM (Page 4) to acknowledge that you have received this notification. Actions to be taken by Getinge: Getinge will update the affected Cardiosave Hybrid IABPs that contain a Type J connector with a Type N connector to correct and address this issue. This voluntary correction notification only affects the products listed on page 1; no other products are affected by this voluntary correction. We apologize for any inconvenience this Medical Device Correction may cause. If you have any questions, please contact your Datascope/Getinge representative or call the Datascope Corp./Getinge Representative or office.

    Distribution

    International distribution in the country of Brazil.

    Quantity

    54 units