FDA Enforcement
Class II
Terminated
THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
Recall: Z-0057-2018
·
Reported November 8, 2017
Enforcement
- Recall Number
- Z-0057-2018
- Event ID
- 78129
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Biosense Webster, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 8, 2017
- Initiation Date
- September 6, 2017
- Classification Date
- October 27, 2017
- Termination Date
- November 19, 2019
- Address
- 15715 Arrow Hwy, N/A, Irwindale, CA, 91706-2006, United States
Description
THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
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.
Code Info
17688816M, 17697930M, 17697966M
Distribution
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
Quantity
19 units