Webster CSRecalls & reported problems across all models

We found 6 models of Webster CS by Biosense Webster Inc in the FDA's device registry (GUDID). Together they are named in 89 adverse event reports in the FDA's MAUDE database, received between Jan 8, 2018 and Sep 18, 2026 — classified as 6 deaths, 39 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (27 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Webster CS problems

Webster CS models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Webster CS BD710DF282CT

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  21 reports
• Webster CS BD710FJ282CT

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  3 deaths17 reports
• Webster CS BD710DF282RTS

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  16 reports
• WEBSTER CS D135304

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  13 reports
• Webster CS BD710FJ282RTS

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  1 death11 reports
• WEBSTER CS D135303

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  2 deaths11 reports

Recent Webster CS adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Adverse Event Without Identified Device or Use Problem

  EZ Steer deca catheter failed related to PIN malfunction./Catheter removed and exchanged with Inquiry deca catheter. No Pt Harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818203 ↗
• InjuryJan 27, 2026Patient Device Interaction Problem

  DURING A PERSISTENT ATRIAL FIBRILLATION (PAF) ABLATION WHILE USING A WEBSTER CS (CORONARY SINUS) CATHETER, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION TREATED CONFIRMED WITH ICE (INTRACARDIAC ECHOCARDIOGRAPHY) CATHETER AND TREATED WITH PERICARDIOCENTESIS AND REMOVAL OF 19ML OF FLUID. PRIOR TO GAINING TRANSSEPTAL ACCESS, THE PATIENT'S BLOOD PRESSURE BEGAN TO DECREASE. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE THE PATIENT WAS KEPT FOR A COUPLE OF DAYS FOR MONITORING THE EFFUSION, AND A TEE (TRANSESOPHAGEAL ECHOCARDIOGRAM) BEING PERFORMED. THE OUTCOME OF THE ADVERSE EVENT FULLY RECOVERED (NO RESIDUAL EFFECTS). THE WEBSTER CS CATHETER IS NOT AVAILABLE FOR RETURN. FARAPULSE SYSTEM WAS PLANNED FOR USE, BUT NO PFA (PULSE FIELD ABLATION) ABLATION WAS PERFORMED. THE FOLLOWING BWI DEVICES WERE ALSO IN USE SOUNDSTAR CATHETER (NOT AVAILABLE FOR RETURN), CARTO 3 SYSTEM. THE WEBSTER CS CATHETER AND THE SOUNDSTAR CATHETER WERE BOTH BRAND NEW. THE INFORMATION RECEIVED INDICATED THAT THIS ADVERSE EVENT WAS DISCOVERED AFTER THE WEBSTER WAS USED ON THE PATIENT. THE PHYSICIAN WAS UNSURE OF WHAT CAUSED THE EVENT. NO TRANSSEPTAL PUNCTURE WAS PERFORMED, BUT VERSACROSS CONNECT LAAC ACCESS SOL

  Patient problems: Cardiac Tamponade

  MAUDE report 24191085 ↗
• InjuryJan 16, 2026Patient Device Interaction Problem

  A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE WITH WEBSTER CS AND A PENTARAY NAV AND THE PATIENT EXPERIENCED BLOOD PRESSURE DROP AND TAMPONADE WHICH WERE TREATED WITH PERICARDIOCENTESIS AND HEPARIN REVERSAL WITH PROTAMINE. DURING THE PVI ABLATION PROCEDURE, THE PHYSICIANS HAD TO BE INFORMED REPEATEDLY THAT THEY WERE HAVING HIGH CONTACT FORCE (UP TO 60 G) AND THAT THE IMPEDANCE WAS RISING DURING ABLATION. WHILE ABLATING THE RIGHT PULMONARY VEINS, THE PATIENT¿S BLOOD PRESSURE STARTED DROPPING. AFTER REPEATING THE MEASUREMENT, AN ECHO WAS PERFORMED, DURING WHICH A TAMPONADE WAS CONFIRMED. THE PHYSICIAN THEN PERFORMED PERICARDIOCENTESIS AND ONLY ASPIRATED VENOUS BLOOD. AFTER THAT, THE BLOOD PRESSURE STABILIZED. SINCE THEY HAD GIVEN A TOTAL OF 7,000UNITS OF HEPARIN AFTER THE TRANSSEPTAL PUNCTURE, THEY DECIDED TO ANTAGONIZE THE HEPARIN WITH 4,000UNITS OF PROTAMINE. AS THE PATIENT WAS STABLE, THE PHYSICIAN DECIDED TO CONTINUE ISOLATING THE LEFT PULMONARY VEINS. AS SOON AS THEY WERE DONE WITH THE PVI AND REMOVED ALL CATHETERS FROM THE LEFT ATRIUM, THEY GAVE AN ADDITIONAL 3,000 UNITS OF PROTAMINE TO ANTAGONIZE ALL THE HEPARIN. THE PHYSICIAN THINKS THAT AS THEY ONLY

  Patient problems: Cardiac Tamponade

  MAUDE report 24092964 ↗
• MalfunctionJan 7, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) PROCEDURE WITH A WEBSTER CS CATHETER. FOREIGN MATERIAL WAS VISUALIZED WITHIN THE STERILE PACKAGING OF THE CATHETER. THE CATHETER WAS REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE ISSUE WAS NOTICED PRIOR TO USE. IT WAS A SMALL BROWN OR BLACK FLECK OF POSSIBLY PLASTIC OR SOME OTHER MATERIAL. THE MATERIAL OBSERVED WAS LOOSE. THEY DECIDED NOT TO USE THE DEVICE AND IT REMAINED UNOPENED WITH THE MATERIAL STILL INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23998931 ↗
• MalfunctionDec 29, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A WEBSTER CS CATHETER. THERE WERE "FLOATING BLACK PARTICLES" WITHIN THE PACKAGING TOWARDS THE HANDLE OF THE CATHETER. THEY DID NOT USE THE CATHETER FOR THE PROCEDURE AND REPLACED IT WITH A NEW ONE. THERE WAS NO PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918749 ↗
• MalfunctionDec 29, 2025Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT UPON RECEIPT OF THE NEW WEBSTER CS CATHETER PRODUCT, IT WAS NOTICED THAT THE PRODUCT PACKAGING WAS DAMAGED. THE CALLER REPORTED THAT THE PRODUCT BOX WAS OPENED AT THE TOP, AND THE BOX ITSELF APPEARS "SQUISHED AND TORN." THE CALLER REPORTED THAT UPON INSPECTION, IT WAS CONFIRMED THAT THERE IS A RIP IN THE STERILE POUCH SEAL OF THE WEBSTER CS CATHETER AS WELL. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905728 ↗
• MalfunctionNov 26, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A WEBSTER CS CATHETER AND THE CURVE OF THE CATHETER WAS STUCK/JAMMED IN A DEFLECTED POSITION. WHEN THE CATHETER BEND WAS RELEASED, IT DID NOT STRAIGHTEN, GIVING THE IMPRESSION THAT THE AREA WHERE THE CATHETER DEFLECTED HAD BEEN FRACTURED. THE CURVE WAS DEFORMED INSTEAD OF STRAIGHT. THE KNOB/PISTON WAS UNABLE TO BE MOVED UP OR DOWN. NO PHYSICAL DAMAGES WERE NOTED ON THE RING, ELECTRODE, OR DISTAL END OF THE CATHETER. NO FURTHER DETAILS WERE PROVIDED REGARDING TROUBLESHOOTING OF THE ISSUE OR COMPLETION OF THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659556 ↗
• MalfunctionNov 26, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER CS AND BEFORE OPENING THE CATHETER FOR THE PROCEDURE, THERE WAS APPROXIMATELY 8MM LENGTH, WITH A DIAMETER OF A THREAD, INSIDE THE PLASTIC TRAY OF THE UNOPENED PACKAGE. THEY OPENED ANOTHER CATHETER AND THE CASE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23654226 ↗
• InjuryOct 31, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A WEBSTER CORONARY SINUS (CS) CATHETER, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS AND REMOVAL OF 200CCS OF BLOOD. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU) FOR 24 HOURS OBSERVATION. IT WAS REPORTED THAT AFTER MAPPING IN THE RIGHT ATRIUM AND RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) AND GOING RETROGRADE INTO THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT), THEY HAD NOTICED THE PATIENT HAD A PERICARDIAL EFFUSION. NO ABLATION HAD OCCURRED. THEY NOTICED ON THE VIVID IQ ULTRASOUND MACHINE DURING INTRACARDIAC ECHOCARDIOGRAPHY (ICE) MANIPULATION. PERICARDIOCENTESIS WAS PERFORMED AND EXTRACTED 200CC'S OF BLOOD. THE PATIENT HAD DISPLAYED NO SYMPTOMS. THE PATIENT STATUS IS CURRENTLY STABLE AND WILL BE HELD OVERNIGHT IN THE ICU FOR 24-HOUR OBSERVATION AND THE PERICARDIAL EFFUSION IS CLEARED. THE THERMOCOOL SMARTTOUCH SF CATHETER, WEBSTER CS CATHETER, AND REPROCESSED STERILMED SOUNDSTAR® CATHETER WERE THE ONLY BIOSENSE WEBSTER INC. (BWI) PRODUCTS IN THE BODY AT THE TIME OF THE EVENT. THE REPORTER STATED THE ONLY CATHETER AVAILABLE FOR RETURN IS THE REPROCESSED STERILMED SOUNDSTA

  Patient problems: Cardiac Tamponade

  MAUDE report 23438555 ↗
• MalfunctionSep 3, 2025Signal Artifact/Noise; Break; Signal Artifact/Noise; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A WEBSTER CS CATHETER AND OBSERVED AN INSULATION BREAK AT THE TIP OF THE CATHETER AND METAL WIRES WERE EXPOSED. THE DISTAL TWO ELECTRODES OF THE CATHETER APPEARED BLACK ON THE CARTO 3 SYSTEM AND THERE WAS NOISE FROM THOSE ELECTRODES ON BOTH THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM. THE CATHETER WAS REMOVED FROM THE BODY AND THEY NOTICED THAT THERE WAS AN INSULATION BREAK AT THE TIP OF THE CATHETER AND METAL WIRES WERE EXPOSED. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE CATHETER WAS BRAND NEW FROM BIOSENSE WEBSTER, INC. BOX PACKAGING. THE DISTAL TWO ELECTRODES OF THE CATHETER APPEARED BLACK ON THE CARTO 3 SYSTEM AND THERE WAS NOISE FROM THOSE ELECTRODES WAS ASSESSED AS NON MDR. THE RISK TO THE PATIENT WAS LOW. THE INSULATION BREAK AT THE TIP OF THE CATHETER AND METAL WIRES WERE EXPOSED ISSUE WAS ASSESSED AS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22955321 ↗
• MalfunctionAug 12, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE WITH A WEBSTER CS CATHETER AND FOREIGN MATERIAL WAS OBSERVED. UNUSUAL PINK COLORED FOREIGN BODY WAS FOUND ON ONE OF THE ELECTRODES OF THE WEBSTER CS CATHETER, POTENTIALLY COMPROMISING THE CATHETER STERILITY AND QUESTIONING THE ORIGIN OF THIS FOREIGN BODY. THE WEBSTER CS WAS NOT INTRODUCED TO THE PATIENT AND IMMEDIATELY REMOVED OFF THE TABLE TO BE REPORTED FOR INVESTIGATION. THE PROCEDURE WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCE. THE FOREIGN BODY WAS NO LONGER FOUND AFTER THE DECONTAMINATION OF THE CATHETER BUT IT IS IMPORTANT TO REPORT IN ORDER TO DOCUMENT AND ENSURE THAT NO FRAGMENTS ARE INTRODUCED TO THE PATIENTS' BLOODSTREAM. NO FRAGMENTS WERE GENERATED. ADDITIONAL INFORMATION WAS RECEIVED. THE CATHETER WAS NOT USED ON THE PATIENT. THE ISSUE WAS NOTICED BEFORE USE. THE CALLER ASKED TO IMMEDIATELY REMOVE IT FROM THE STERILE ZONE AS WAS NOT SURE AT THAT POINT WHETHER THE CATHETER WAS OKAY TO BE USED OR NOT. ALSO DID NOT WANT TO INTRODUCE ANY FOREIGN MATERIAL OF ANY SORT TO THE PATIENT¿S BLOOD, ESPECIALLY WITH DOUBTS ABOUT THE CATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783498 ↗
• InjuryJul 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A WEBSTER CS CATHETER AND AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND PRIOR TO ABLATION ENERGY DELIVERY, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION THAT REQUIRED DRAINAGE AND PROLONGED HOSPITALIZATION. DURING MAPPING PHASE, PRIOR TO ABLATION ENERGY DELIVERY, THE PATIENT HAD A PERICARDIAL EFFUSION. THIS WAS NOTED AFTER THEY WENT TRANSSEPTAL WITH THE VERSACREST WIRE. THE OPTRELL CATHETER WAS IN THE LEFT ATRIUM FOR MAPPING TO CONFIRM WHERE THEY WERE AND NOTICED SOME PERICARDIAL FLUID IN THE RIGHT VENTRICLE. THE PERICARDIAL FLUID WAS CONFIRMED ON ICE AND X-RAY. AT THIS POINT, THE PHYSICIAN ABORTED THE PROCEDURE AND PROVIDED MEDICAL INTERVENTION BY DRAINING THE PERICARDIAL FLUID FROM AROUND THE HEART BY DOING PERICARDIOCENTESIS. AFTER THE PERICARDIAL FLUID WAS DRAINED, THE PATIENT REMAINED STABLE WHICH WAS ALSO THE LAST KNOWN STATUS. THE CASE WAS ABORTED WHILE MAPPING IN THE LEFT ATRIUM. THE OUTCOME OF THE ADVERSE EVENT WAS THAT THE PATIENT FULLY RECOVERED (NO RESIDUAL EFFECTS). THE PATIENT REQUIRED EXTENDED HOSPITALIZATION, BECAUSE OF OVERNIGHT INSTEAD OF BEING DISCHARGED SAME DAY. O

  Patient problems: Cardiac Tamponade

  MAUDE report 22401297 ↗
• MalfunctionJun 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PERSISTENT ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A HOLE ON THE PEBAX WITH INTERNAL PARTS EXPOSED AND ROCKER ARM DETACHED. DURING THE PROCEDURE, WHEN GOING ON ABLATION USING Q MODE, THE "HI" FORCE READING WAS DISPLAYED ON THE CARTO 3 SYSTEM. THE MEDICAL TEAM TRIED TO REZERO TWICE WITHOUT RESOLUTION. THE CABLE WAS REPLACED WITH NO RESOLUTION. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310566 ↗
• MalfunctionJun 23, 2025Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A WEBSTER® CS BI-DIRECTIONAL CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB REVEALED FOREIGN MATERIAL IN THE DOME AREA. DURING THE PROCEDURE, THERE WAS NOISE DISPLAYED ON THE DISTAL BIPOLAR SIGNALS FOR THE WEBSTER® CS BI-DIRECTIONAL CATHETER, ON THE CARTO¿ 3 AND RECORDING SYSTEM. THE CABLE WAS REPLACED WITHOUT RESOLUTION. THE WEBSTER® CS BI-DIRECTIONAL CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310431 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND THE CATHETER HAD A BROKEN TIP/SHAFT. THE DEVICE WAS DISCOVERED TO BE BROKEN BEFORE USAGE IN THE PATIENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21997857 ↗

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