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Biosense Webster Inc

United States·US-MF-000014219

Last updated September 17, 2026

Information

Country: United States
Address: 31, Technology Drive, Suite 200, Irvine, California, United States
Website: its.jnj.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)729-9010
PRRC Contact: Tucky Wong
EUDAMED SRN: US-MF-000014219
FDA FEI Number: 3022451073
DUNS Number: 020163218

Catalogue (618)

Page 11 of 13

Device	Model / Reference	Registries	Class	Status
VARIPULSE™ Bi-Directional Catheter	D141201	FDA UDI	Class III	Active
NuVision ICE Catheter	FG10593	FDA UDI	Class II	Active
TX eco Cable Dongle Spare Part	M599902SP	FDA UDI	Class III	Active
Webster Compli	F6CQF252RT	FDA UDI	Class II	Unknown
Ismus	D7R20LCSRT	FDA UDI	Class II	Unknown
EZ Steer ThermoCool NAV	BNI75TCDDH	FDA UDI	Class III	Active
Webster Compli	F6CQA005RT	FDA UDI	Class II	Active
CARTO 3 System eco Interface Cable	D134401	EUDAMEDFDA UDI	Class I	Active
Halo Xp Electrophysiology Catheter	36J14R	EUDAMED	Class III	Active
Parahisian Electrophysiology Catheter	36L00Q	EUDAMED	Class III	Active
CARTO 3 System Interface cable	D129707	EUDAMEDFDA UDI	Class I	Active
NUVISION Connector Cable	FG10594	EUDAMEDFDA UDI	Class I	Active
HELIOSTAR Balloon Ablation Catheter	D138904	EUDAMED	Class III	Active
CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module	K173978	FDA 510(k)	Class II	Active
Soundstar Eco Diagnostic Ultrasound Catheter	K112050	FDA 510(k)	Class II	Active
Pentaray Nav Eco High-Density Mapping Catheter	K123837	FDA 510(k)	Class II	Active
Carto3 Ep Navigation System, Version 3.2	K132782	FDA 510(k)	Class II	Active
CARTO™ 3 EP Navigation System V8.4	K252972	FDA 510(k)	Class II	Active
CARTO™ 3 EP Navigation System V9.0 with PIU Plus	K254085	FDA 510(k)	Class II	Active
CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT	K180238	FDA 510(k)	Class II	Active
CARTO 3 EP Navigation System, Version 7.1 and Accessories	K191660	FDA 510(k)	Class II	Active
NUVISION™ NAV Ultrasound Catheter	K223766	FDA 510(k)	Class II	Active
Carto Xp Ep Navigation System, Version 10	K093566	FDA 510(k)	Class II	Active
Soundstar 3d Ultrasound Catheter, Model M-5723-12	K092064	FDA 510(k)	Class II	Active
Flower High-Density Mapping Catheter, 4-4-4 Mm Electrode Spacing), (2-6-2 Mm Electrode Spacing)	K050217	FDA 510(k)	Class II	Active
NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter	K241540	FDA 510(k)	Class II	Active
Noga Xp Cardiac Navigation System With Qwikmap Software	K053194	FDA 510(k)	Class II	Active
Preface Guiding Sheath, Models 2-603m, 2-703m, 2-803m, 2-903m, 2-1003m, 2-1103m	K001139	FDA 510(k)	Class II	Active
Carto Xp Ep Navigation System, Software Verison 8	K042999	FDA 510(k)	Class II	Active
Carto 3 Ep Navigation System, V1.0 And Accessories	K090017	FDA 510(k)	Class II	Active
Carto Xp Ep Navigation System, Version 9	K070240	FDA 510(k)	Class II	Active
Carto Octaray Mapping Catheter with Trueref Technology	K193237	FDA 510(k)	Class II	Active
Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From Line 2	K113213	FDA 510(k)	Class II	Active
Carto 3 Ep Navigation System, Version 2.0 (w/Standard Location Pad), Carto3 Epnavigation System, Version 2.0 W/Rmt Pad)	K103746	FDA 510(k)	Class II	Active
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath	K170997	FDA 510(k)	Class II	Active
Pentaray Nav eco High-Density Mapping Catheter	K201750	FDA 510(k)	Class II	Active
OPTRELL™ Mapping Catheter with TRUEref™ Technology	K230253	FDA 510(k)	Class II	Active
CARTO 3 EP Navigation System Version 7.2	K213264	FDA 510(k)	Class II	Active
Lasso Nav Catheter	K093376	FDA 510(k)	Class II	Active
Soundstar 3d Diagnostic Catheter, Model M-5723-05	K091352	FDA 510(k)	Class II	Active
Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02	K081258	FDA 510(k)	Class II	Active
Webster Cs Catheter With Ez Steer Technology, Webster Cs Catheter With Ez Steer Technology And Auto Id Model: D-1263-04,	K101345	FDA 510(k)	Class II	Active
Modification To Carto Ep Navigation System	K000190	FDA 510(k)	Class II	Active
Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01, Webster Cs Catheter With Ez Steer	K090898	FDA 510(k)	Class II	Active
Biosense Webster Patient Cable And Leadwires	K001390	FDA 510(k)	Class II	Active
CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)	K231207	FDA 510(k)	Class II	Active
Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220	K002333	FDA 510(k)	Class II	Active
Soundstar 3d Ultrasound Catheter, Model M-5723-05	K070242	FDA 510(k)	Class II	Active
OPTRELL Mapping Catheter with TRUEref Technology	K211438	FDA 510(k)	Class II	Active
Coronary Sinus Deflectable Mapping Catheter, 4 Fr, 5 Fr, 6 Fr & 7 Fr	K050877	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

Biosense Webster A Division of Johnson & Johnson Medical NV/SA BE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (60)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 5, 2025	Z-1205-2025	—	open, classified	Due to an observed trend of neurovascular events
Feb 16, 2024	Z-1290-2024	—	open, classified	Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
Feb 21, 2023	Z-1319-2023	—	open, classified	Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch
Feb 21, 2023	Z-1320-2023	—	open, classified	Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch
Jun 29, 2022	Z-1677-2022	—	open, classified	Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside. Devices with a compromised sterile barrier could be a source for infection.
Feb 26, 2021	Z-1286-2021	—	completed	There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism
Feb 26, 2021	Z-1285-2021	—	completed	There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism
Feb 26, 2021	Z-1287-2021	—	completed	There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism
Apr 22, 2020	Z-2371-2020	—	terminated	Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
Apr 22, 2020	Z-2372-2020	—	terminated	Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
May 7, 2018	Z-2878-2018	—	terminated	When attempting to recapture the 32-mm device, the tip of the delivery sheath may fold or buckle, resulting in increased retraction force and difficulty or failure to recapture the device.
Sep 6, 2017	Z-0054-2018	—	terminated	Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.
Sep 6, 2017	Z-0058-2018	—	terminated	Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.
Sep 6, 2017	Z-0056-2018	—	terminated	Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.
Sep 6, 2017	Z-0055-2018	—	terminated	Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.
Sep 6, 2017	Z-0057-2018	—	terminated	Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.
Jun 14, 2017	Z-0210-2018	—	terminated	Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
May 17, 2017	Z-0211-2018	—	terminated	Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
May 17, 2017	Z-0212-2018	—	terminated	Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
Aug 15, 2016	Z-2776-2016	—	terminated	Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical Services, as described in the Instructions for Use (IFU).
Apr 14, 2016	Z-1591-2016	—	terminated	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.
Apr 14, 2016	Z-1590-2016	—	terminated	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.
Sep 10, 2015	Z-0003-2016	—	terminated	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.
Sep 10, 2015	Z-0002-2016	—	terminated	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.
Apr 17, 2015	Z-1525-2015	—	terminated	The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System.
Mar 19, 2015	Z-1691-2015	—	terminated	Biosense Webster is recalling the SMARTABLATE Generator System because Biosense Webster has received two complaints reporting that during an RMT procedure the SMARTABLATE RF Generator inadvertently delivered RF energy.
Feb 25, 2015	Z-1242-2015	—	terminated	Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover.
Oct 19, 2014	Z-0139-2015	—	terminated	The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.
Feb 20, 2014	Z-1176-2014	—	terminated	Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have partial tip separation from the catheter shaft. Biosense Webster is expanding the recall on 5/1/14 to include all lots of the PentaRay Nav Catheter and the PentaRay Nav ECO Catheter because they can lead to an insufficient bond of the distal tip to the catheter shaft.
Feb 12, 2014	Z-1045-2014	—	terminated	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.
Jun 19, 2013	Z-1617-2013	—	terminated	Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated causing them to be recognized and displayed as a 10-Pole LASSO NAV Catheter Eco by the CARTO 3 System.
Mar 5, 2013	Z-1023-2013	—	terminated	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.
Feb 9, 2012	Z-1230-2012	—	terminated	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.
Jul 7, 2011	Z-3178-2011	—	terminated	Biosense Webster has initiated a voluntary field notification to all customers that have a Stockert 70 Radio Frequency Generator, to communicate undetected software anomalies in the form of software release note in order to amend the labeling and thereby enhance the safety of the product.
May 23, 2011	Z-2665-2011	—	terminated	The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes catheters with Auto ID Technology are not being recognized when connected to the CARTO 3 System.
May 23, 2011	Z-2664-2011	—	terminated	The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes catheters with Auto ID Technology are not being recognized when connected to the CARTO 3 System.
May 23, 2011	Z-2667-2011	—	terminated	The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes catheters with Auto ID Technology are not being recognized when connected to the CARTO 3 System.
May 23, 2011	Z-2666-2011	—	terminated	The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes catheters with Auto ID Technology are not being recognized when connected to the CARTO 3 System.
Apr 29, 2011	Z-3037-2011	—	terminated	The recall was expanded because between February and April 2011, Biosense Webster, Inc. notified customers that a voluntary Customer Notification had been Initiated due to the inaccessibility of the electronic version of the Instructions for Use (e-IFU) for the "10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue", Catalog Number D128709, through the J&J Gateway (i.e., e-IFU websi
Apr 29, 2011	Z-3038-2011	—	terminated	The recall was expanded because between February and April 2011, Biosense Webster, Inc. notified customers that a voluntary Customer Notification had been Initiated due to the inaccessibility of the electronic version of the Instructions for Use (e-IFU) for the "10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue", Catalog Number 0128709, through the J&J Gateway (i.e., e-IFU websi
Feb 15, 2011	Z-1839-2011	—	terminated	The recall was initiated because Biosense Webster has confirmed that there is an inaccessibility of electronic version of the instruction for use (e-IFU) for the "10 ft. Interface Cable, 10 Pin-Shielded Tip Pins to 12 Pin-Blue", catalog number D128709, through the J&J Gateway (ie, e-IFU website).
Nov 22, 2010	Z-0983-2012	—	terminated	Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter: 1. If phrenic nerve location is a concern, precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode, such as pacing maneuvers. 2. To minimize risk of atrio-esophageal fist
Nov 22, 2010	Z-0981-2012	—	terminated	Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter: 1. If phrenic nerve location is a concern, precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode, such as pacing maneuvers. 2. To minimize risk of atrio-esophageal fist
Nov 22, 2010	Z-0982-2012	—	terminated	Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter: 1. If phrenic nerve location is a concern, precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode, such as pacing maneuvers. 2. To minimize risk of atrio-esophageal fist
Nov 22, 2010	Z-0980-2012	—	terminated	Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter: 1. If phrenic nerve location is a concern, precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode, such as pacing maneuvers. 2. To minimize risk of atrio-esophageal fist
Nov 22, 2010	Z-0979-2012	—	terminated	Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter: 1. If phrenic nerve location is a concern, precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode, such as pacing maneuvers. 2. To minimize risk of atrio-esophageal fist
Oct 5, 2010	Z-0884-2011	—	terminated	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.
Nov 17, 2009	Z-2369-2012	—	terminated	The recall was initiated because Biosense Webster has become aware of information regarding a potential hazard that may occur during the operation of a Bloom EP Stimulator device in conjunction with RF generators and other electrophysiology (EP) equipment, including the CARTO 3 Electropysiology Mapping System.
Mar 25, 2008	Z-1704-2008	—	terminated	This recall was initiated after the firm received several complaints reporting issues with deflection. The catheter may become caught in the mitral valve, requiring surgical procedures, valve may be torn while trying to dislodge, unable to retract the catheter through the sheath and require surgical intervention to remove, pulling on catheter to remove may lead to large atrial septal tear, and sep
Mar 25, 2008	Z-1703-2008	—	terminated	This recall was initiated after the firm received several complaints reporting issues with deflection. The catheter may become caught in the mitral valve, requiring surgical procedures, valve may be torn while trying to dislodge, unable to retract the catheter through the sheath and require surgical intervention to remove, pulling on catheter to remove may lead to large atrial septal tear, and sep
Dec 15, 2007	Z-1647-2012	—	terminated	The recall was initiated because the catheter unit was shipped with a label expiration date of 9/30/2010, which is 11 months beyond the correct expiration date of 10/31/2009.
Nov 17, 2006	Z-0539-2007	—	terminated	Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath during use in the left atrium.
Nov 17, 2006	Z-0540-2007	—	terminated	Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath during use in the left atrium.
Nov 17, 2006	Z-0537-2007	—	terminated	Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath during use in the left atrium.
Nov 17, 2006	Z-0541-2007	—	terminated	Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath during use in the left atrium.
Nov 17, 2006	Z-0538-2007	—	terminated	Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath during use in the left atrium.
Aug 8, 2005	Z-0057-06	—	terminated	Increased complaints regarding catheters with leaks and flow obstruction.
Aug 16, 2004	Z-1437-04	—	terminated	Potential that product is incorrectly assembled with monel wire attached to the tip dome rather than copper wire.
Jul 16, 2004	Z-1328-04	—	terminated	Generator Failure resulting increase of catheter temperature that could not be controlled by power reduction.
May 21, 2004	Z-1006-04	—	terminated	Mislabeling.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Biosense Webster, Inc. JUAREZ Chihuahua · MX FEI 3003248396