Biosense Webster, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0057-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)

Product Classification:

Class II

Date Initiated: September 6, 2017

Date Posted: November 8, 2017

Recall Number: Z-0057-2018

Event ID: 78129

Reason for Recall:

Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.

Status: Terminated

Product Quantity: 19 units

Code Information:

17688816M, 17697930M, 17697966M

Distribution Pattern:

US, Japan, Canada, Australia, New Zealand, Brazil, Croatia, Korea, Austria, Colombia, Italy, Portugal, Argentina, South Africa, Belgium, France, Germany, Ireland, Poland, Netherlands, Sweden, Denmark, Finland, Switzerland, Great Britain, Hungary, Czech Republic, China

Voluntary or Mandated:

Voluntary: Firm initiated