Biosense Webster Recalls THERMOCOOL Catheters Due to Magnetic Distortion Alert
Biosense Webster is recalling THERMOCOOL catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (unintended ablation) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Biosense Webster, Inc. is recalling specific lots of THERMOCOOL SMARTTOUCH SF Bi-Directional catheters. The recall involves product codes D-1348-01-S, D-1348-04-S, and D-1348-05-S. A total of 1,962 units were distributed to the 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, and China.
The recall was initiated after the manufacturer received an increased number of complaints regarding the display of 'Alert 402' on the CARTO 3 System when these catheters are connected. Alert 402 indicates a 'Map: magnetic distortion.' This false alert may cause a physician to deliver radiofrequency (RF) energy in an unintended area during an ablation procedure.
Healthcare providers should stop using the affected catheters and contact Biosense Webster for further instructions. Patients who have had procedures using these devices should consult their healthcare provider if they have concerns.
The recalled product
- Product
- THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S
- Manufacturer
- Biosense Webster, Inc.
- Affected units
- 1,962
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Biosense Webster, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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