Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CARTO 3 System (Software Version V7.1.80) Recalled by Biosense Webster (israel), Ltd. Due to Software defect may result in disapperance of tag...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Biosense Webster (israel), Ltd. directly.
Affected Products
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 location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure, Product Number: -5400-00, UDI: 10846835000870
Quantity: N/A
Why Was This Recalled?
Software defect may result in disapperance of tag sites during recalculation and lead to additional ablation sites. This may lead to prolongation of the procedure and, in extremely rare circumstances, cardiac perforation.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Biosense Webster (israel), Ltd.
Biosense Webster (israel), Ltd. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report