Nov

2017

Cl II THERMOCOOL SMARTTOUCH Bi-Directional

Company:Biosense Webster, Inc.
Date of Enforcement Report 11/8/2017
Class lI:

PRODUCT

THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S
Recall Number Z-0055-2018

REASON
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..

RECALLING FIRM/MANUFACTURER
Biosense Webster, Inc., Irwindale CA. on 9/16/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1962 units

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II THERMOCOOL SMARTTOUCH Bi-Directional

Amy Sellers

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