BEUDAMED
    FDA Enforcement Class I Ongoing

    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, 0998-00-0800-55

    Recall: Z-1145-2023 · Reported March 15, 2023

    Enforcement

    Recall Number
    Z-1145-2023
    Event ID
    91602
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Datascope Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 15, 2023
    Initiation Date
    February 7, 2023
    Classification Date
    March 9, 2023
    Address
    1300 Macarthur Blvd, Mahwah, NJ, 07430-2052, United States

    Description

    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, 0998-00-0800-55

    Reason

    An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the communication between the display head and base unit.

    Code Info

    All serial numbers. Model 0998-00-0800-31, UDI-DI 10607567109053; Model 0998-00-0800-32, UDI-DI 10607567111117; Model 0998-00-0800-33, UDI-DI 10607567109008; Model 0998-00-0800-34, UDI-DI 10607567111940; Model 0998-00-0800-35, UDI-DI 10607567109107; Model 0998-00-0800-45, UDI-DI 10607567108421; Model 0998-00-0800-52, UDI-DI 10607567108438; Model 0998-00-0800-53, UDI-DI 10607567108391; Model 0998-00-0800-55, UDI-DI 10607567108414; Model 0998-00-0800-65, UDI-DI 10607567113432

    Distribution

    Worldwide Distribution: US (nationwide) and OUS (Foreign) ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, BRUNEI , BULGARIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GHANA, HONG KONG, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KUWAIT, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MEXICO, MOROCCO, MYANMAR, NETHERLANDS, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PHILIPPINES, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TURKEY, TURKMENISTAN, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM, AND YEMEN.

    Quantity

    4062 Total