Biosense Webster, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0139-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.

Product Classification:

Class II

Date Initiated: October 19, 2014

Date Posted: November 5, 2014

Recall Number: Z-0139-2015

Event ID: 69532

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.

Status: Terminated

Product Quantity: 173,329 units total (21,812 units in US)

Code Information:

Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603 All Lots manufactured from launch (Dec 2010)

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated