Biosense Webster Recalls THERMOCOOL SMARTTOUCH Navigation Catheters
Biosense Webster is recalling 64 THERMOCOOL SMARTTOUCH 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of significant injury (unintended ablation) due to a device malfunction, meeting the criteria for a Severe rating.
Plain-English summary
Biosense Webster, Inc. is recalling 64 units of the THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (models D-132704-S and D-132705-S). The recall was initiated after the company received 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." The presence of this 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 catheters and contact Biosense Webster for further instructions. The specific lot codes associated with this recall are 17445775M, 17694994M, 17697951M, 17685286M, 17697907M, 17697991M, 17691864M, 17697910M, and 17697994M.
The recalled product
- Product
- THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)
- Manufacturer
- Biosense Webster, Inc.
- Affected units
- 64
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.
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