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.
FDA Recall Z-1156-2010 · Posted 2010-03-17
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Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeLPB
Date Initiated2009-09-22
Date Terminated2010-12-27
Product Quantity75 units
Reason for Recall
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US and to Spain, France, Germany, Italy, Russia, Poland, the Netherlands, Israel and Belgium
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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