ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D
FDA device recall Z-0139-2015 · posted 2014-10-27 · Terminated
Recall details
- Recalling firm
- Biosense Webster, Inc.
- 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.
- 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.
- Root cause
- Use error
- Status
- Terminated
- Product code
- LPB
- Quantity affected
- 173,329 units total (21,812 units in US)
- Distribution
- Nationwide Distribution
- Date initiated
- 2014-10-19
- Date posted
- 2014-10-27
- Date terminated
- 2015-10-06
- Location
- Irwindale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.