Recall Z-1156-2010 ยท LPB Cardiac Ablation Percutaneous Catheter
Boston Scientific Corp
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 ventric
| Date | Mar 17, 2010 (initiated Sep 22, 2009) |
| Status | Terminated |
| 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. |
| Root cause | 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 | 75 units |
| Distribution | US and to Spain, France, Germany, Italy, Russia, Poland, the Netherlands, Israel and Belgium |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.