Z-0056-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 8, 2017
- Initiation Date
- September 6, 2017
- Termination Date
- November 19, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64 units
Product Description
THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)
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.
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
Code Information
17445775M 17694994M 17697951M 17685286M 17697907M 17697991M 17691864M 17697910M 17697994M