Biosense Webster, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0058-2018)

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 SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S

Product Classification:

Class II

Date Initiated: September 6, 2017

Date Posted: November 8, 2017

Recall Number: Z-0058-2018

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: 329 units

Code Information:

17637495L 17638389L 17639706L 17639707L 17639708L 17640039L 17640494L 17640952L 17640040L 17640742L 17640953L 17640041L 17640743L 17640954L 17640490L 17640744L 17643130L 17638118L 17638387L 17638388L

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