Z-0057-2018 Class II Terminated
FDA device recall Z-0057-2018 was initiated by Biosense Webster, Inc. on September 6, 2017 and is designated Class II. 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 impli… The recall status is terminated (terminated November 19, 2019). Affected quantity: 19 units.
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
- 19 units
Product Description
THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
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
17688816M, 17697930M, 17697966M