BEUDAMED
    FDA Recall Open, Classified

    CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.

    Recall: Z-3136-2024 · Initiated August 8, 2024

    Recall

    Recall Number
    Z-3136-2024
    Event Number
    95168
    Firm
    Datascope Corp.
    FEI Number
    3001418283
    Product Code
    DSP
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    August 8, 2024
    Posted
    September 20, 2024
    Address
    1300 Macarthur Blvd, Mahwah, NJ, 07430-2052

    Description

    CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.

    Reason

    Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.

    Action

    Consignees were mailed an URGENT FIELD SAFETY NOTICE dated 8/5/2024. This notification informs consignees of the deployment of previously installed software to mitigate previously identified issues in Cardiosave Hybrid and/or Cardiosave Rescue Intra-Aortic Balloon Pump devices. Consignees are asked to examine their inventory immediately to identify if they have any Cardiosave Hybrid and/or Rescue IABP devices, and to identify what software version is currently installed in devices. Devices with software revision D.00 or D.01 have been corrected. If consignee units have a software version lower than D.00 or D.01 (e.g.: B.XX or C.XX) the device still requires the software update and has not yet been corrected. If consignee units do not have the corrected software revision installed, they are to continue

    Distribution

    International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA , AUSTRIA, AUSTRALIA, BELGIUM, BULGARIA, BAHRAIN, BRAZIL, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, GERMANY, DENMARK, ECUADOR, EGYPT, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, INDONESIA, IRELAND, INDIA, IRAQ, IRAN, ITALY, JORDAN, JAPAN, SOUTH KOREA, KUWAIT, LEBANON, LITHUANIA, LIBYA, MOROCCO, MYANMAR, MEXICO, MALAYSIA, NETHERLANDS, NORWAY, NEW ZEALAND, OMAN, PHILIPPINES, POLAND, PALESTINE, PORTUGAL, SERBIA, RUSSIAN FEDERATION, SAUDI ARABIA, SWEDEN, SINGAPORE, SLOVAKIA, THAILAND, TURKEY, TAIWAN, UNITED KINGDOM, VIETNAM, YEMEN.

    Quantity

    5,475 units