BEUDAMED
    FDA Recall Open, Classified

    LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.

    Recall: Z-0131-2023 · Initiated August 5, 2022

    Recall

    Recall Number
    Z-0131-2023
    Event Number
    90913
    Firm
    Datascope Corporation
    FEI Number
    1000222374
    Product Code
    DSQ
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    August 5, 2022
    Posted
    October 24, 2022
    Address
    15 Law Dr, Fairfield, NJ, 07004-3206

    Description

    LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.

    Reason

    The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients who are more hemodynamically unstable.

    Action

    On August 5, 2022, the firm notified affected customers via Urgent Field Safety Notice Medical Device Removal letters. Customers were instructed to examine their inventory for the affected product. Customers may return the product for full credit. The firm also informed customers that given current supply chain shortages that they are unable to commit to a timely replacement of affected catheters.

    Distribution

    No US distribution. Foreign distribution to Argentina, Brazil, Canada, Chile, Columbia, Ecuador, Egypt, France, Indonesia, Israel, Italy, Jordan, Kenya, Malaysia, Mexico, Netherlands, Pakistan, Poland, Portugal, South Korea, Russia, Spain, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay.

    Quantity

    4414 OUS