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U.S. Department of Health and Human Services

Class 2 Device Recall CircuCool Fluid Circulation Pump

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  Class 2 Device Recall CircuCool Fluid Circulation Pump see related information
Date Initiated by Firm September 22, 2009
Date Posted March 17, 2010
Recall Status1 Terminated 3 on December 27, 2010
Recall Number Z-1156-2010
Recall Event ID 53463
PMA Number P980003 
Product Classification Cardiac ablation percutaneous catheter - Product Code LPB
Product 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.
Code Information Serial numbers:  A9003399 to A9003418, B08003046 to B08003050, B08004180 to B08004209, D08003578 to D08003597, E09002815 to E09002839, G08002514 to G08002533, and K08005118 to K08005137
Recalling Firm/
Manufacturer		 Boston Scientific Corp
150 Baytech Dr
San Jose CA 95134-2302
For Additional Information Contact
408-935-3400
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
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.
Quantity in Commerce 75 units
Distribution US and to Spain, France, Germany, Italy, Russia, Poland, the Netherlands, Israel and Belgium
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LPB and Original Applicant = Boston Scientific Corp.
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