Biosense Webster, Inc. recalls
22 recalls in our records from 2012 to 2025: 22 FDA medical devices.
Recalls with full detail pages
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Biosense Webster, Inc. medical device recall: VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field…
Due to an observed trend of neurovascular events
Earlier and other recalls
These link to the official agency notice.
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Biosense Webster, Inc. medical device recall: CARTO VIZIGO Bi-Directional Guiding Sheath Official notice ↗
Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
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Biosense Webster, Inc. medical device recall: Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath Official notice ↗
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…
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Biosense Webster, Inc. medical device recall: CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath Official notice ↗
Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of…
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Biosense Webster, Inc. medical device recall: Biosense Webster Official notice ↗
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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Biosense Webster medical device recall: PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only… Official notice ↗
Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
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Biosense Webster, Inc. medical device recall: WaveCrest Left Atrial Appendage Official notice ↗
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…
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Biosense Webster, Inc. medical device recall: SMARTABLATE RF System Generator Official notice ↗
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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Biosense Webster, Inc. medical device recall: PENTARAY NAV High-Density Mapping Catheter Official notice ↗
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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Biosense Webster, Inc. medical device recall: THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S Official notice ↗
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…
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Biosense Webster, Inc. medical device recall: CARTO 3 EP Navigation System and Accessories Official notice ↗
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…
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Biosense Webster, Inc. medical device recall: Pentaray NAV High-Density Mapping Catheter Official notice ↗
Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter…
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Biosense Webster, Inc. medical device recall: Carto 3 EP Navigation System. Electro physiology system which views… Official notice ↗
Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion.…
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Biosense Webster, Inc. medical device recall: SMARTABLATE RF Generator System Official notice ↗
Biosense Webster is recalling the SMARTABLATE Generator System because Biosense Webster has received two complaints reporting that during an RMT procedure the…
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Biosense Webster, Inc. medical device recall: WEBSTER HIS Catheter Official notice ↗
The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System.
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Biosense Webster, Inc. medical device recall: LASSO NAV Duo Loop eco Catheters Official notice ↗
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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Biosense Webster, Inc. medical device recall: ThermoCool SmartTouch Navigation Catheters Official notice ↗
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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Biosense Webster, Inc. medical device recall: PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO… Official notice ↗
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…
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Biosense Webster, Inc. medical device recall: CartoUnivu Module Official notice ↗
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…
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Biosense Webster, Inc. medical device recall: 20-Pole LASSO Nav Catheter Eco Official notice ↗
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…
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Biosense Webster, Inc. medical device recall: 20-Pole Eco Cable Official notice ↗
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…
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Biosense Webster, Inc. medical device recall: CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for… Official notice ↗
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…
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.