ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
- Company
- Biosense Webster, Inc.
- Recall Initiated
- October 19, 2014
- Posted
- October 27, 2014
- Terminated
- October 6, 2015
- Recall Number
- Z-0139-2015
- Quantity
- 173,329 units total (21,812 units in US)
- Firm Location
- Irwindale, CA
Reason for Recall
The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.
Distribution
Nationwide Distribution
Lot / Code Info
Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603 All Lots manufactured from launch (Dec 2010)
Root Cause
Use error
Action Taken
A customer notification letter dated October 19, 2014, will be sent to all customers who purchased the Biosense Webster's ThermoCool SmartTouch Catheter Family. The letter informs the customers of the additional information for the safe and effective use of the ThermoCool SmartTouch Catheter, which will be included in the updated labeling. The letter informs the customers of the problems identified and the actions to be taken. Customers with questions related to the recall letter are instructed to contact their Biosense Webster sales representative or call (866) 473-7823, Monday through Friday from 7am to 8pm EST.