Recall Z-0139-2015
Biosense Webster, Inc. · initiated October 19, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
Codes / lots: Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603 All Lots manufactured from launch (Dec 2010)
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.
FDA-determined 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.
Details
- Recall number
- Z-0139-2015
- Initiated
- October 19, 2014
- Posted by FDA
- October 27, 2014
- Terminated
- October 6, 2015
- Product code
- LPB – Cardiac Ablation Percutaneous Catheter
- Quantity
- 173,329 units total (21,812 units in US)
- Distribution
- Nationwide Distribution
- Recalling firm
- Biosense Webster, Inc., Irwindale, CA