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.
This recall has been terminated (originally issued March 17, 2010).
- Company
- Boston Scientific Corp
- Recall Initiated
- September 22, 2009
- Posted
- March 17, 2010
- Terminated
- December 27, 2010
- Recall Number
- Z-1156-2010
- Quantity
- 75 units
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
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.
Distribution
US and to Spain, France, Germany, Italy, Russia, Poland, the Netherlands, Israel and Belgium
Lot / Code Info
Serial numbers: A9003399 to A9003418, B08003046 to B08003050, B08004180 to B08004209, D08003578 to D08003597, E09002815 to E09002839, G08002514 to G08002533, and K08005118 to K08005137
Root Cause
Nonconforming Material/Component
Action Taken
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.