Biosense Webster Recalls CARTO 3 System Software Due to Defect
Biosense Webster is recalling the CARTO 3 System software due to a defect that may cause tag sites to disappear, potentially leading to cardiac perforation.
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 cardiac perforation, which constitutes a significant injury risk under the severity rubric.
Plain-English summary
Biosense Webster (Israel), Ltd. is recalling the CARTO 3 System (Software Version V7.1.80) and the CARTO VISITAG Module. The recall covers all serial numbers of the product, which is used for catheter-based cardiac electrophysiological (EP) procedures to monitor heart electrical activity and catheter location.
The recall is being conducted because a software defect may cause tag sites to disappear during recalculation. This issue could lead to additional ablation sites, prolonging the procedure. In extremely rare circumstances, the defect may result in cardiac perforation.
The affected products were distributed worldwide, including nationwide distribution in the United States and to three U.S. government consignees. The recall also includes distribution to numerous international countries. Users of the system should contact the manufacturer for further instructions regarding the software defect.
The recalled product
- Product
- CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides information about the electrical activity of the heart and about catheter…
- Manufacturer
- Biosense Webster (israel), Ltd.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
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