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BIOSENSE WEBSTER INC

CARTO 3 · Cardiovascular

510(k): 17 Recall: 10 UDI: 16 MAUDE: 10 Class.: 63

510(k) Clearances (17)

CARTO 3 EP Navigation System V8.4

2026-02-20

Substantially Equivalent

CARTO 3 EP Navigation System V9.0 with PIU Plus

2026-01-18

Substantially Equivalent

CARTO 3 EP Navigation System V8.1

2025-08-22

Substantially Equivalent

CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)

2023-09-07

Substantially Equivalent

CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)

2022-08-17

Substantially Equivalent

CARTO 3 EP Navigation System Version 7.2

2021-10-29

Substantially Equivalent

CARTO 3 EP Navigation System, Version 7.1 and Accessories

2019-07-20

Substantially Equivalent

CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module

2018-08-24

Substantially Equivalent

CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module

2018-06-14

Substantially Equivalent

CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT

2018-06-01

Substantially Equivalent

CARTO 3 EP Navigation System, Version 6.0 and Accessories

2017-07-25

Substantially Equivalent

CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2

2014-07-01

Substantially Equivalent

CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2

2011-10-05

Substantially Equivalent

CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD)

2011-01-21

Substantially Equivalent

CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES

2009-12-04

Substantially Equivalent

CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES

2009-10-13

Substantially Equivalent

CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01)

2007-11-19

Substantially Equivalent

Recalls (10)

VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used for TRUPULSE Generator, for the treatment of drug refractory recurrent symptomatic paroxysmal atrial f

2025-01-05

Due to an observed trend of neurovascular events

CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/o

2024-02-16

Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.

Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimulat

2016-04-14

Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to patients with prosthetic valves.

Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stim

2016-04-14

Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.

2015-09-10

Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when used with the SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. New precautions added.

LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06. LASSO NAV DUO LOOP eco Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is

2015-02-25

Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover.

CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAYED IN THE CART0 3 SYSTEM. THESE IMAGES ARE NOT FOR DIAGNOSTIC PURPOSES. WHEN FLUOROSCOPIC CAPTURES ARE

2014-02-12

Biosense Webster has initiated a recall of the CartoUnivu Module within the Carto 3 System (V3.2.2 and V3.2.3) when used with Siemens Axiom Artis VB Fluoroscopy systems in particular procedural configurations only. If the table rotation is not returned to zero point, there is a misalignment between the Carto 3 System map display and the fluoroscopic capture.

20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.

2013-03-05

Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a catheter is connected to an affected to an affected 20-Pole Eco Cable, the catheter will not be recognized by the impacted 54 cable serial numbers within the field.

CARTO 3 Systems, Product Code M-4800-01 The intended use of the CARTO 3 System is catheter-based cardiac electrophysiological (EP) procedures.

2012-02-09

Some CARTO 3 Systems may get radio frequency interference through certain interconnected cable configurations resulting in jumping or disappearing catheter icon and/or error messages during ablation.

CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18; Catalog Number CR3410CT This product provides a signal interface between a Biosense Webster electrophysiology catheter and the appropriate equipment. This cable may be re-used subject to established cleaning and ste

2010-10-05

When connecting this cable to the mapping system, loss of Body Surface ECG signals may occur. This may result in inaccurate locations appearing for catheters displayed 3D on the CARTO monitor.

UDI Registrations (16)

Carto 3

CARTO 3

Carto 3

CARTO 3 System eco Interface Cable

Interface Cable

Carto 3

Reference Patch CARTO 3

Carto 3

CARTO 3

Carto 3

MAUDE Adverse Events (10)

Injury

20200706

Malfunction

20200701

Malfunction

20200618

Malfunction

20200617

Malfunction

20200610

Malfunction

20200605

Malfunction

20200528

Malfunction

20200511

Injury

20200506

Malfunction

20200501

FDA Classification (63)

Cpr Aid Feedback Device (No Software)

Cardiovascular

Dilator, Vessel, For Percutaneous Catheterization

Cardiovascular

Predictive Indicator For Long-Term Cardiovascular Outcomes

Cardiovascular

Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon

Cardiovascular

Pulse Oximeter For Over-The-Counter Use

Cardiovascular

Introducer, Catheter

Cardiovascular

Catheter, Oximeter, Fiber Optic, Reprocessed

Cardiovascular

Transducer, Blood-Pressure, Extravascular

Cardiovascular

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Cardiovascular

Low Patient Acuity Monitoring System

Cardiovascular

Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement

Cardiovascular

Outpatient Cardiac Telemetry

Cardiovascular

Apical Closure Device

Cardiovascular

Filter, Intravascular, Cardiovascular

Cardiovascular

Cardiovascular Surgical Instruments Tray

Cardiovascular

Digital Angiography Tray

Cardiovascular

Pulse-Generator, Pacemaker, External

Cardiovascular

Ultrasonic Body Composition Analyzer

Cardiovascular

Coronary Mechanical Thrombectomy With Aspiration

Cardiovascular

Catheters, Transluminal Coronary Angioplasty, Percutaneous

Cardiovascular

Bag, Polymeric Mesh, Pacemaker

Cardiovascular

Transducer, Heart Sound

Cardiovascular

Central Venous Catheter Tray

Cardiovascular

Septostomy Catheter, Reprocessed

Cardiovascular

Oximeter, Tissue Saturation

Cardiovascular

Catheter, Intravascular, Diagnostic

Cardiovascular

Ballistocardiograph

Cardiovascular

Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures

Cardiovascular

Monitor, St Segment

Cardiovascular

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Cardiovascular

Software Device System For Estimation Of Cardiac Pressures

Cardiovascular

Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass

Cardiovascular

Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

Cardiovascular

Dc-Defibrillator, Low-Energy, (Including Paddles)

Cardiovascular

Peripheral Mechanical Thrombectomy With Aspiration

Cardiovascular

Vectorcardiograph

Cardiovascular

Reprocessed Blood Pressure Cuff

Cardiovascular

Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures

Cardiovascular

Optical Coherence Tomography, Intravascular Catheter

Cardiovascular

Holder, Heart-Valve, Prosthesis

Cardiovascular

Magnet, Test, Pacemaker

Cardiovascular

Marker, Cardiopulmonary Bypass (Vein Marker)

Cardiovascular

Catheter, Thrombus Retriever

Cardiovascular

Percutaneous Catheter, Ultrasound

Cardiovascular

Syringe, Balloon Inflation

Cardiovascular

Catheter, Intravascular Occluding, Temporary

Cardiovascular

Cannula, Catheter

Cardiovascular

Detector And Alarm, Arrhythmia

Cardiovascular

Loss Of Pulse Notification Software

Cardiovascular

Winged Intravenous Catheterization Kit

Cardiovascular

Device, Vascular, For Promoting Embolization

Cardiovascular

Cardiovascular Delivery Catheter System Positioning And Stabilization Device

Cardiovascular

Over-The-Counter Automated External Defibrillator

Cardiovascular

Suction Control, Intracardiac, Cardiopulmonary Bypass

Cardiovascular

Injector, Contrast Medium, Automatic, Reprocessed

Cardiovascular

Clip, Vascular

Cardiovascular

Oximeter, Infrared, Sporting, Aviation

Cardiovascular

Oximeter, Ear

Cardiovascular

Electrocardiograph Software For Over-The-Counter Use

Cardiovascular

Filter, Prebypass, Cardiopulmonary Bypass

Cardiovascular

Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation

Cardiovascular

Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass

Cardiovascular

Computer, Diagnostic, Programmable

Cardiovascular