Medical DeviceMar 12, 2025
Biosense Webster VARIPULSE Bi-Directional Ablation Catheter REF D141201 recall — FDA Z-1205-2025
Due to an observed trend of neurovascular events
Class IFDA: OngoingBiosense Webster, Inc.
Recall history in this database
Classification mix: Class II: 20, Class I: 2.
Medical DeviceMar 20, 2024
Biosense Webster CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM recall — FDA Z-1290-2024
Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
Class IIFDA: OngoingBiosense Webster, Inc.
Medical DeviceApr 12, 2023
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S recall — FDA Z-1319-2023
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
Class IIFDA: OngoingBiosense Webster, Inc.
Medical DeviceApr 12, 2023
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S recall — FDA Z-1320-2023
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
Class IIFDA: OngoingBiosense Webster, Inc.
Medical DeviceSep 14, 2022
Biosense Webster CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501 recall — FDA Z-1677-2022
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.…
Class IIFDA: OngoingBiosense Webster, Inc.
Medical DeviceMar 31, 2021
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF recall — FDA Z-1286-2021
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
Class IIFDA: CompletedBiosense Webster, Inc.
Medical DeviceMar 31, 2021
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF recall — FDA Z-1285-2021
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
Class IIFDA: CompletedBiosense Webster, Inc.
Medical DeviceMar 31, 2021
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF recall — FDA Z-1287-2021
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
Class IIFDA: CompletedBiosense Webster, Inc.
Medical DeviceSep 5, 2018
Biosense Webster WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog recall — FDA Z-2878-2018
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.
Class IFDA: TerminatedBiosense Webster, Inc.
Medical DeviceDec 13, 2017
Biosense Webster SMARTABLATE RF System Generator recall — FDA Z-0210-2018
Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
Class IIFDA: TerminatedBiosense Webster, Inc.
Medical DeviceDec 13, 2017
Biosense Webster PENTARAY NAV High-Density Mapping Catheter recall — FDA Z-0211-2018
Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
Class IIFDA: TerminatedBiosense Webster, Inc.
Medical DeviceDec 13, 2017
Biosense Webster PENTARAY NAV High-Density Mapping Catheter recall — FDA Z-0212-2018
Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
Class IIFDA: TerminatedBiosense Webster, Inc.
Medical DeviceNov 8, 2017
Biosense Webster THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT recall — FDA Z-0058-2018
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.…
Class IIFDA: TerminatedBiosense Webster, Inc.
Medical DeviceNov 8, 2017
Biosense Webster THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S recall — FDA Z-0054-2018
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.…
Class IIFDA: TerminatedBiosense Webster, Inc.
Medical DeviceNov 8, 2017
Biosense Webster THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S) recall — FDA Z-0057-2018
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.…
Class IIFDA: TerminatedBiosense Webster, Inc.
Medical DeviceNov 8, 2017
Biosense Webster THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S recall — FDA Z-0055-2018
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.…
Class IIFDA: TerminatedBiosense Webster, Inc.
Medical DeviceNov 8, 2017
Biosense Webster THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter recall — FDA Z-0056-2018
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.…
Class IIFDA: TerminatedBiosense Webster, Inc.
Medical DeviceSep 21, 2016
Biosense Webster CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and recall — FDA Z-2776-2016
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…
Class IIFDA: TerminatedBiosense Webster, Inc.
Medical DeviceMay 11, 2016
Biosense Webster Pentaray NAV High-Density Mapping Catheter, Catalog No recall — FDA Z-1590-2016
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…
Class IIFDA: TerminatedBiosense Webster, Inc.
Medical DeviceMay 11, 2016
Biosense Webster Pentaray NAV High-Density Mapping ECO Catheter, Catalog No recall — FDA Z-1591-2016
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…
Class IIFDA: TerminatedBiosense Webster, Inc.
Medical DeviceOct 7, 2015
Biosense Webster SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters recall — FDA Z-0003-2016
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…
Class IIFDA: TerminatedBiosense Webster, Inc.
Medical DeviceOct 7, 2015
Biosense Webster Carto 3 EP Navigation System recall — FDA Z-0002-2016
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…
Class IIFDA: TerminatedBiosense Webster, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Biosense Webster, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.