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Biosense Webster, Inc. recalls THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
Recalled November 8, 2017 · FDA recall Z-0057-2018 · Biosense Webster
Hazard
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. · FDA Class II
Units
19 units
Sold at
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
Description
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.
Product
THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
Manufacturer(s)
Biosense Webster, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →