BEUDAMED
    FDA Recall Terminated

    8 Fr 30cc Narrow Flex IAB Catheter Kit with Generica Adapters Product Number: IAB-04830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.

    Recall: Z-1210-2009 · Initiated February 2, 2009

    Recall

    Recall Number
    Z-1210-2009
    Event Number
    51080
    Firm
    Arrow International, Inc.
    FEI Number
    3010532612
    Product Code
    DSP
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    February 2, 2009
    Posted
    April 16, 2009
    Terminated
    July 6, 2010
    Address
    9 Plymouth St, Everett, MA, 02149-1814

    Description

    8 Fr 30cc Narrow Flex IAB Catheter Kit with Generica Adapters Product Number: IAB-04830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.

    Reason

    A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume.

    Action

    An "Urgent Medical Device Recall" letter dated February 2, 2009 was issued to consignees via US Certified Mail to notify users of the problem. Users were instructed to check their inventory for the affected products, quarantine, and return the them to Arrow International, Inc. Customers were also instructed to follow the "Mitigation Directions" in circumstances where alternate Intra-Aortic Balloon (IAB) catheters/adaptors or other forms of therapy are not available (until receipt of available product). Canadian accounts were notified on February 9, 2009 by courier and International accounts notified on 6 February 2009 and 10 February 2009 via Registered Post/UPS. Direct questions to your local Sales Representative or the Arrow International Customer Service at 1-800-523-8446 (US) or 1-919-361-4062 (outside US). Press Release issued April 13, 2009 is posted to firm's webiste: http://www.arrowintl.com/iab_recall.asp.

    Distribution

    Worldwide Distribution: USA, Argentina, Australia, Taiwan, Singapore, New Zealand, India, Brazil, Belgium, Korea, Peru, Finland, and Denmark.

    Quantity

    1,572 units