ThermoCool SmartTouch Navigation Catheters, Catalog No.… recallZ-0139-2015 · Biosense Webster, Inc. · initiated Oct 19, 2014
Class II Terminated All recalls posted in October 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biosense Webster, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.
FDA root cause category: Use error
What the company is doing
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.
Recall details
- Recall number
- Z-0139-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 19, 2014
- Posted by the FDA
- Oct 27, 2014
- Recalling firm
- Biosense Webster, Inc.
- Quantity
- 173,329 units total (21,812 units in US)
- Product code
- LPB
- FDA submissions
- P030031, P040036
- Distribution
- Nationwide Distribution
Product description
ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
Code information (models, lots, serial numbers)
Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603 All Lots manufactured from launch (Dec 2010)
Other devices under the same FDA submission
38 devices cleared under P030031, P040036 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- THERMOCOOL SMARTTOUCH SF D134805Biosense Webster Inc · Cardiac ablation percutaneous catheter1 recall176 deaths4,106 reports
- THERMOCOOL SMARTTOUCH SF D134804Biosense Webster Inc · Cardiac ablation percutaneous catheter44 deaths784 reports
- THERMOCOOL SMARTTOUCH SF D134801Biosense Webster Inc · Cardiac ablation percutaneous catheter15 deaths608 reports
- ThermoCool SmartTouch D132705Biosense Webster Inc · Cardiac ablation percutaneous catheter25 deaths574 reports
- THERMOCOOL SMARTTOUCH SF D134702Biosense Webster Inc · Cardiac ablation percutaneous catheter19 deaths366 reports
- THERMOCOOL SMARTTOUCH SF D134701Biosense Webster Inc · Cardiac ablation percutaneous catheter11 deaths278 reports
- ThermoCool SmartTouch D133602Biosense Webster Inc · Cardiac ablation percutaneous catheter8 deaths225 reports
- ThermoCool SmartTouch D133601Biosense Webster Inc · Cardiac ablation percutaneous catheter10 deaths162 reports
- ThermoCool SmartTouch D132704Biosense Webster Inc · Cardiac ablation percutaneous catheter7 deaths121 reports
- NaviStar ThermoCool NI75TCDHBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter111 reports
- THERMOCOOL SMARTTOUCH SF D134703Biosense Webster Inc · Cardiac ablation percutaneous catheter3 deaths72 reports
- ThermoCool SmartTouch D132701Biosense Webster Inc · Cardiac ablation percutaneous catheter51 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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