Biosense Webster, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0054-2018)

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 SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S

Product Classification:

Class II

Date Initiated: September 6, 2017

Date Posted: November 8, 2017

Recall Number: Z-0054-2018

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: 357 units

Code Information:

17682851L 17682730L 17685880L 17685740L 17685692L 17680131L 1768581 lL 17685897L 17685789L 17676998L 17685889L 17685896L 17685792L 17685741L 17685758L 17685846L 17689428L 17689420L 17685881L 17680081L 17689454L 17682788L 17685853L 17685750L 17692068L 17689430L 17680080L 17682787L 17692069L 17689463L 17689421L 17685691L

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