BEUDAMED
    FDA Recall Terminated

    Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS

    Recall: Z-1259-2015 · Initiated November 8, 2013

    Recall

    Recall Number
    Z-1259-2015
    Event Number
    70603
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    DSP
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 8, 2013
    Posted
    March 10, 2015
    Terminated
    March 16, 2015
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS

    Reason

    Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.

    Action

    Arrow International Inc notified accounts by letter dated 11/8/13 describing the problem and requested users to immediately discontinue use and return product. A Recall Acknowledgement form was to be completed and returned.

    Distribution

    Distribution US nationwide (including AZ, NJ, ME, TX, WA), and Germany.

    Quantity

    166 units