Biosense Webster, Inc. — Federal Records

FDA Device Recall: CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM B 2024-03-20

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

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FDA Device Recall: Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D- 2023-04-12

Class II — 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

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FDA Recall: Biosense Webster, Inc. — Class II 20210331

There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleedin | Product: Biosense Webster, CARTO VIZIGO, Bi-Dir...

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FDA Device Recall: Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, 2021-03-31

Class II — 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

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FDA Device Recall: Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, 2021-03-31

Class II — 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

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FDA Device Recall: Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, 2021-03-31

Class II — 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

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FDA Device Recall: PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE 2020-06-24

Class II — Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.

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FDA Recall: Biosense Webster, Inc. — Class I 20180905

When attempting to recapture the 32-mm device, the tip of the delivery sheath may fold or buckle, resulting in increased retraction force and difficul | Product: WaveCrest Left Atrial Appendage (LAA),...

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FDA Device Recall: WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers 2018-09-05

Class I — 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.

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FDA Device Recall: SMARTABLATE RF System Generator 2017-12-13

Class II — Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.

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FDA Device Recall: PENTARAY NAV High-Density Mapping Catheter. 2017-12-13

Class II — Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.

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FDA Device Recall: THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D- 2017-11-08

Class II — 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. Aler...

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FDA Device Recall: THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, 2017-11-08

Class II — 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. Aler...

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FDA Device Recall: CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG5400 2016-09-21

Class II — 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 ...

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FDA Device Recall: Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D12820 2016-05-11

Class II — 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 w...

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FDA Device Recall: Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D1 2016-05-11

Class II — 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 w...

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FDA Recall: Biosense Webster, Inc. — Class II 20151007

Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing perica | Product: SOUNDSTAR eco 8F and 10F Diagnostic Ul...

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FDA Device Recall: SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and 2015-10-07

Class II — 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...

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FDA Device Recall: SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M49 2015-06-03

Class II — 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 inadv...

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FDA Device Recall: LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D 2015-03-11

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

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FDA Recall: Biosense Webster, Inc. — Class II 20140319

Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have partial tip separation from the catheter shaft. Biosen | Product: PENTARAY NAV High-Density Mapping Cath...

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FDA Device Recall: ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D13270 2014-11-05

Class II — The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.

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FDA Device Recall: PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalo 2014-03-19

Class II — 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...

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FDA Device Recall: CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. 2014-02-26

Class II — 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 proce...

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FDA Recall: Biosense Webster, Inc. — Class II 20130710

Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated causing them to be recognized and displaye | Product: 20-Pole LASSO Nav Catheter Eco, Catalo...

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FDA Device Recall: 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate 2013-07-10

Class II — 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 b...

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FDA Device Recall: 20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable 2013-04-03

Class II — 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 re...

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FDA Recall: Biosense Webster, Inc. — Class II 20120919

The recall was initiated because Biosense Webster has become aware of information regarding a potential hazard that may occur during the operation of | Product: CARTO 3 V1.05(FG-5400-00). The CART...

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FDA Device Recall: CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter- 2012-09-19

Class II — 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 conjunc...

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