BEUDAMED
    FDA Recall Terminated

    AutoCAT 2 Series Intra-Aortic Balloon Pumps Catalog No: IAP-0400, IAP-0435, IAP-0500, and IAP-0535, Arrow International, Everett, MA 02149

    Recall: Z-0550-2008 · Initiated November 12, 2007

    Recall

    Recall Number
    Z-0550-2008
    Event Number
    45871
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    DSP
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    November 12, 2007
    Posted
    January 25, 2008
    Terminated
    January 11, 2010
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    AutoCAT 2 Series Intra-Aortic Balloon Pumps Catalog No: IAP-0400, IAP-0435, IAP-0500, and IAP-0535, Arrow International, Everett, MA 02149

    Reason

    Leak may occur in the helium drive system for the IABP

    Action

    Arrow International notified customers by letter dated November, 2007 titled: Urgent Medical Device Field Correction. Customers are instructed to follow the Recommended Action included in the letter while awaiting replacement of the defective component to be performed by service representative.

    Distribution

    Worldwide- USA, including the states of CA, CO, FL, IN, KS, MA, MO, NV, NY, PA, SC, TN, TX, and WA and countries of Canada, Africa, Argentina, Austria, Bangladesh, Belarus, Belgium, Brazil, Canada, Columbia, Czech Rep, UK, Finland, France, Germany, Hungary, India, Indonesia, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Panama, Philippines, Portugal, Russia, Saudi Arabia, Italy, Spain, Sweden, Taiwan, and Turkey.

    Quantity

    225 units