Biosense Webster Recalls THERMOCOOL Catheters Due to System Alert Error
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 involves a risk-of-harm product where injury has not yet been reported, as the false alert may lead to unintended ablation but no specific injuries are cited in the source text.
Plain-English summary
Biosense Webster, Inc. is recalling 357 units of THERMOCOOL SMARTTOUCH SF Uni-Directional catheters (Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S). The recall is due to an increased number of complaints regarding the display of Alert 402 on the CARTO 3 System when these specific catheters are connected.
Alert 402 indicates a "Map: magnetic distortion." This false alert may lead a physician to ablate in an unintended area when delivering RF energy. The affected units were distributed in 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.
Healthcare providers should stop using the affected lots and contact Biosense Webster for further instructions. Consumers are not directly affected as these are professional medical devices.
The recalled product
- Product
- THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
- Manufacturer
- Biosense Webster, Inc.
- Affected units
- 357
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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