THERMOCOOL SMARTTOUCH SF Uni-Directional recall
THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
Why was THERMOCOOL SMARTTOUCH SF Uni-Directional recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
17682851L 17682730L 17685880L 17685740L 17685692L 17680131L 1768581 lL 17685897L 17685789L 17676998L 17685889L 17685896L 17685792L 17685741L 17685758L 17685846L 17689428L 17689420L 17685881L 17680081L 17689454L 17682788L 17685853L 17685750L 17692068L 17689430L 17680080L 17682787L 17692069L 17689463L 17689421L 17685691L
- Product
- THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
- Recalling firm
- Biosense Webster, Inc.
- Quantity
- 357 units
- 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
- Recall date
- November 8, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)