Biosense Webster Recalls THERMOCOOL SF NAV Catheters Due to Display Error
Biosense Webster is recalling THERMOCOOL SF NAV catheters because a system alert may cause physicians to ablate in unintended areas.
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 (ablation in an unintended area) during a medical procedure, meeting the criteria for a Severe rating.
Plain-English summary
Biosense Webster, Inc. is recalling 329 units of THERMOCOOL SF NAV Catheters (Model Numbers BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-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 catheter lots are connected.
Alert 402 indicates a "Map: magnetic distortion." This issue 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 instructions on return or replacement. Patients who have had procedures using these devices should contact their healthcare provider if they have concerns.
The recalled product
- Product
- THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
- Manufacturer
- Biosense Webster, Inc.
- Category
- Medical Device — Catheters
- Affected units
- 329
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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