BEUDAMED
    FDA Recall Terminated

    CircuCool Fluid Circulation Pump used in the Chilli Cooled Ablation System, Model Number M00480050, manufactured by Barnant ThermoFisher Scientific, Barrington, IL. Distributed by Boston Scientific Corporation, San Jose, CA. The Chilli Cooled Ablation System is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli and radiofrequency ablation of mappable ventricular tachycardias attributable to ischemic heart disease or cardiomyopathy in patients who have failed drug therapy.

    Recall: Z-1156-2010 · Initiated September 22, 2009

    Recall

    Recall Number
    Z-1156-2010
    Event Number
    53463
    Firm
    Boston Scientific Corp
    FEI Number
    3001236349
    Product Code
    LPB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 22, 2009
    Posted
    March 17, 2010
    Terminated
    December 27, 2010
    Address
    150 Baytech Dr, San Jose, CA, 95134-2302

    Description

    CircuCool Fluid Circulation Pump used in the Chilli Cooled Ablation System, Model Number M00480050, manufactured by Barnant ThermoFisher Scientific, Barrington, IL. Distributed by Boston Scientific Corporation, San Jose, CA. The Chilli Cooled Ablation System is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli and radiofrequency ablation of mappable ventricular tachycardias attributable to ischemic heart disease or cardiomyopathy in patients who have failed drug therapy.

    Reason

    Product failure-- Product may cease operation as a result of potential speed control board failure when the device is shut off, and may not turn back on. A component on the circuit board fails unexpectedly because of a power surge, causing a diode to burn out.

    Action

    The firm has issued notification letters via Federal express with reply verification tracking forms. A follow up letter and telephone survey as needed will be sent to follow up with non-responders. The firm is asking its consignees to return any recalled product. If there are any questions, please call 1.408.935.4952.

    Distribution

    US and to Spain, France, Germany, Italy, Russia, Poland, the Netherlands, Israel and Belgium

    Quantity

    75 units