RegWardenFDA facility compliance records
Company

BIOSENSE WEBSTER, INC.

23 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2009: 1 recalls; 2013: 2 recalls; 2014: 3 recalls; 2015: 4 recalls; 2016: 2 recalls; 2017: 3 recalls; 2018: 1 recalls; 2020: 2 recalls; 2021: 1 recalls; 2022: 1 recalls; 2023: 1 recalls; 2024: 1 recalls; 2025: 1 recalls1’09’10’11’122’133’144’152’163’171’18’192’201’211’221’231’241’25’26
  • Recalls (23)

Registered facilities (4)

Recalls & enforcement

20251 record
20241 record
  • Class IIOngoing2024-02-16
    Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
20231 record
  • Class IIOngoing2023-02-21
    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
20221 record
  • Class IIOngoing2022-06-29
    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.
20211 record
  • Class IICompleted2021-02-26
    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
20202 records
  • Class IITerminated2020-06-22
    Software defect may result in disapperance of tag sites during recalculation and lead to additional ablation sites. This may lead to prolongation of the procedure and, in extremely rare circumstances, cardiac perforation.
  • Class IITerminated2020-04-22
    Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
20181 record
  • Class ITerminated2018-05-07
    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.
20173 records
  • Class IITerminated2017-09-06
    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…
  • Class IITerminated2017-06-14
    Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
  • Class IITerminated2017-05-17
    Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
20162 records
  • Class IITerminated2016-08-15
    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).
  • Class IITerminated2016-04-14
    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.
20154 records
  • Class IITerminated2015-09-10
    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 Dia…
  • Class IITerminated2015-04-17
    The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System.
  • Class IITerminated2015-03-19
    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.
  • Class IITerminated2015-02-25
    Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover.
20143 records
  • Class IITerminated2014-10-19
    The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.
  • Class IITerminated2014-02-20
    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 be…
  • Class IITerminated2014-02-12
    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…
20132 records
  • Class IITerminated2013-06-19
    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.
  • Class IITerminated2013-03-05
    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.
20091 record
  • Class IITerminated2009-11-17
    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 E…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “BIOSENSE WEBSTER, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9044811-biosense-webster-inc/

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