FDAJune 22, 2020device
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 proce...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
biosense webster israelbiosensebiosense webster
UPCs
10846835000870
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAGE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global...2025-12-24
- FDASMV DSI, System, Tomography, Computed, Emission2025-12-10
- FDASMV DSX New Line, System, Tomography, Computed, Emission2025-12-10
- FDASMV BodyTrack, System, Tomography, Computed, Emission2025-12-10
- FDAMAXXUS, System, Tomography, Computed, Emission2025-12-10
- FDAElscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging2025-09-12
- FDAElscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging2025-09-12
- FDAElscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging2025-09-12
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