BEUDAMED
    FDA Enforcement Class II Ongoing

    Cardiosave Rescue. Model Number: 0998-00-0800-83.

    Recall: Z-1232-2023 · Reported March 15, 2023

    Enforcement

    Recall Number
    Z-1232-2023
    Event ID
    91642
    Classification
    Class II
    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 6, 2023
    Address
    1300 Macarthur Blvd, Mahwah, NJ, 07430-2052, United States

    Description

    Cardiosave Rescue. Model Number: 0998-00-0800-83.

    Reason

    Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.

    Code Info

    Model Number: 0998-00-0800-83. UDI-DI: 10607567108407. All serial numbers.

    Distribution

    Nationwide US distribution. Worldwide international distribution.

    Quantity

    47 units (44 US, 3 OUS)