Z-1156-2010

CircuCool Fluid Circulation Pump used in the Chilli Cooled Ablation System, Model Number M00480050...

Name: Z-1156-2010 CircuCool Fluid Circulation Pump used in the Chilli Cooled Ablation System, Model Number M00480050...
Creator: Boston Scientific Corp
Published: 2009-09-22
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2009-09-22 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corp began a recall of CircuCool Fluid Circulation Pump used in the Chilli Cooled Ablation System, Model Number M00480050, manufactured by Barnant ThermoFisher Scientific... on 2009-09-22. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1156-2010
Status: Terminated
Initiated: 2009-09-22
Posted: 2010-03-17
Terminated: 2010-12-27
Recalling firm: Boston Scientific Corporation
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.
Product code: LPB Cardiac Ablation Percutaneous Catheter
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 75 units
Distribution: US and to Spain, France, Germany, Italy, Russia, Poland, the Netherlands, Israel and Belgium
Product codes and lots: Serial numbers: A9003399 to A9003418, B08003046 to B08003050, B08004180 to B08004209, D08003578 to D08003597, E09002815 to E09002839, G08002514 to G08002533, and K08005118 to K08005137

Product code LPB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)