Model note · EP Mapping System

Biosense Webster CARTO 3 EP Navigation System

Name: Biosense Webster CARTO 3 EP Navigation System
Brand: CARTO

CARTO 3 is a 3D electroanatomical mapping system used in electrophysiology labs to build real-time maps of the heart and show where catheters sit during arrhythmia diagnosis and ablation. It combines magnetic sensor location for the catheter tip with current-based Advanced Catheter Location (ACL) for electrodes along the shaft, which reduces reliance on fluoroscopy for catheter visualisation.

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The model

Maker, model and type.

Maker: Biosense Webster, Inc. (Johnson & Johnson MedTech)
Model: CARTO 3 EP Navigation System
Device type: EP Mapping System
Main document: Open the public document

Key specifications

What the public record says.

Item	Value	Source
Location technologies	Magnetic sensor technology (catheter tip) and Advanced Catheter Location, ACL (shaft electrodes)	Source
Hardware components	Patient Interface Unit (PIU), workstation with GUI, wide-screen monitors, intracardiac in and out ports, power supply, patches connection box and cables, pedals, Location Pad, Signal Processing Unit	Source
External reference patches	Six patches, three on the chest and three on the back	Source
Catalogue numbers	FG-5400-00, FG-5400-00U	Source
Regulatory class	FDA Class II programmable diagnostic computer, 21 CFR 870.1425, product code DQK	Source
Map types	Activation, propagation, potential and chamber geometry maps, plus body surface ECG and intracardiac electrograms	Source
Latest cleared version found	Software V9.0 with improved PIU Plus (K254085, January 2026)	Source

Recalls

Known FDA recalls.

Z-2369-20122009-11-17
Potential hazard when a Bloom EP stimulator was used with RF generators and other equipment on CARTO 3 V1.05.
FDA record
Z-0884-20112010-10-05
System interface cable could lose body surface ECG signals, causing inaccurate catheter locations on the 3D display.
FDA record
Z-1230-20122012-02-09
RF interference through some cable configurations caused jumping or disappearing catheter icons and error messages during ablation.
FDA record
Z-1045-20142014-02-12
CARTOUnivu module (V3.2.2 and V3.2.3) issue with Siemens Axiom Artis VB fluoroscopy systems in certain configurations.
FDA record
Z-0002-20162015-09-10
Ultrasound image disappeared when CARTO 3 needed restarting; affects the CARTOSOUND module.
FDA record
Z-2776-20162016-08-15
Correction to reinstall systems moved and installed in China without Biosense Webster testing and approval.
FDA record
Z-2880-20202020-06-22
VISITAG module software (V7.1.80) could lose tag sites during recalculation, risking extra ablation.
FDA record

Safety

Safety warnings from the record.

A software defect in the VISITAG module (V7.1.80) could make ablation tags disappear during recalculation, leading to extra ablation and, rarely, perforation. Check the installed version against the correction. Source
When the system needed restarting, the image disappeared from the connected ultrasound system in a reported case during pericardial effusion. Plan for imaging continuity if CARTO must be rebooted mid-case. Source
A hazard was identified when a Bloom EP stimulator was used together with RF generators and other equipment on CARTO 3 V1.05; check approved equipment combinations. Source
Catheter location data depend on specialised mapping catheters and reference devices; only use accessories specified for the system. Source

Sources

Where this note comes from.

Not covered: No public operator or service manual was found, so error messages, location accuracy figures, power and environmental specs, and the service troubleshooting procedure are not included; no manufacturer product page for the base system was located.

BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.

EP Mapping System