CircuCool Fluid Circulation Pump used in the Chilli Cooled Ablation System, Model Number M00480050, manufactured by Barn
FDA device recall Z-1156-2010 · posted 2010-03-17 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LPB
- Quantity affected
- 75 units
- Distribution
- US and to Spain, France, Germany, Italy, Russia, Poland, the Netherlands, Israel and Belgium
- Date initiated
- 2009-09-22
- Date posted
- 2010-03-17
- Date terminated
- 2010-12-27
- Location
- San Jose, CA
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