Z-0139-2015Class II

ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601...

Name: Z-0139-2015 ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601...
Creator: Biosense Webster, Inc.
Published: 2014-10-19
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2014-10-19 / Terminated / root cause: labeling and UDI

FDA source

Biosense Webster, Inc. began a recall of ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603 on 2014-10-19. FDA classified it as Class II and gives the reason as "The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0139-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-19
Posted: 2014-10-27
Terminated: 2015-10-06
Recalling firm: Biosense Webster Inc
Product: ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
Product code: LPB Cardiac Ablation Percutaneous Catheter
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.
Root cause tag: labeling and UDI
FDA root cause: Use error
Action: 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.
Quantity in commerce: 173,329 units total (21,812 units in US)
Distribution: Nationwide Distribution
Product codes and lots: Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603 All Lots manufactured from launch (Dec 2010)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0139-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0139-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-27

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)