WEBSTER D728260RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10846835004960), received between Oct 12, 2017 and Apr 21, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION AND A LEFT APPENDAGE OCCLUSION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS AND DRAIN PLACEMENT. EARLY DURING THE CASE, AFTER GOING TRANSSEPTAL, THE PATIENT ENDED UP DEVELOPING A PERICARDIAL EFFUSION. THE FIRST SIGN WAS THE DROP OF BLOOD PRESSURE WHICH THE PHYSICIAN CONFIRMED USING THE ICE (INTRACARDIAC ECHOCARDIOGRAPHY) NUVISION¿ ULTRASOUND CATHETER. THE PATIENT WAS IMMEDIATELY TAPPED AND A DRAIN WAS PUT IN PLACE BY THE ELECTROPHYSIOLOGIST. THE MEDICAL TEAM CONTINUED TO MONITOR THE PATIENT FOR ABOUT 30-45 MINUTES, AND SOME HEPARIN WAS ADMINISTERED TO ENSURE THE EFFUSION WOULD NOT TRIGGER. THE NUVISION¿ ULTRASOUND CATHETER WAS USED TO GUIDE THE WATCHMAN¿ PORTION OF THE CASE, SO THEY DID TAKE THE CATHETER ACROSS THE SEPTUM, AFTER GOING TRANSSEPTAL. THE EFFUSION FORMED AFTER THE CATHETER WAS BROUGHT BACK TO THE RIGHT SIDE, IN A PERIOD OF ABOUT TWO MINUTES AFTER. THE EFFUSION DID NOT COME BACK AND THE PHYSICIAN CONTINUED WITH THE CASE. THEY COMPLETED THE ABLATION AND FOLLOW UP WATCHMAN. THE CASE CONTINUED AND ENDED SUCCESSFULLY

  Patient problems: Cardiac Tamponade

  MAUDE report 21875418 ↗
• InjuryFeb 8, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT IN HER 60'S UNDERWENT A CARDIAC ABLATION PROCEDURE THAT INCLUDED USE OF THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND EXPERIENCED CARDIAC TAMPONADE AND REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED THAT A PERICARDIAL EFFUSION WAS NOTICED A LITTLE BIT AFTER THE ABLATION AND PROCEDURE HAD BEEN COMPLETED. THE CALLER REPORTED THAT THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE AFTER THE PROCEDURE WAS COMPLETED. IT WAS NOTED THAT THE BLOOD PRESSURE HAD BEEN STABLE THROUGHOUT THE PROCEDURE. IT WAS CONFIRMED WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) THAT THERE WAS "A LITTLE BIT OF FLUID" IN THE LEFT VENTRICLE IN THE PERICARDIAL SAC. THE CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS. ABOUT 200 CCS OF BLOOD WERE REMOVED FROM THE PATIENT AND 150 CCS OF BLOOD WERE PUT BACK INTO THE PATIENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME OF THE CALL. THE CALLER REPORTED THAT THE PHYSICIAN BELIEVED THAT THE PERICARDIAL EFFUSION MAY HAVE BEEN CAUSED EARLY IN THE PROCEDURE WITH THE DUO-DECA CATHETER. THE CALLER REPORTED THAT IT WAS CONFIRMED THROUGH IC

  Patient problems: Cardiac Tamponade

  MAUDE report 16329556 ↗
• InjurySep 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A DEF 7F, 20P, DOME, DUO-DECAPOLAR AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT A PERICARDIAL EFFUSION OCCURRED DURING A CARTO PROCEDURE. IT WAS NOTICED AFTER TRANSSEPTAL PUNCTURE. A PERICARDIOCENTESIS WAS PERFORMED. PHYSICIAN ASSUMED THAT PERICARDIAL EFFUSION HAPPENED DURING CATHETER MANEUVER PRIOR TO TRANSSEPTAL PUNCTURE. PATIENT WAS FINE AND RELEASED FROM HOSPITAL WITH NO CONSEQUENCES. THE ADVERSE EVENT OCCURRED ON (B)(6) 2022. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. A SMARTABLATE GENERATOR (G4C-5196) WAS USED IN THE EVENT. PRIOR TO NOTING THE PERICARDIAL EFFUSION, ABLATION WAS NOT PERFORMED. THERE WAS NO EVIDENCE OF A STEAM POP. THE EVENT OCCURRED DURING THE TRANSSEPTAL PHASE. AN IRRIGATED CATHETER WAS USED IN THE EVENT, THE FLOW SETTING WAS 17/30 ML.

  Patient problems: Cardiac Tamponade

  MAUDE report 15415836 ↗
• InjuryJun 13, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 77-YEAR-OLD MALE PATIENT (96KG) UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND A DUO-DECAPOLAR ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. DURING AN AFIB CASE AND WATCHMAN DEVICE IMPLANT, A CARDIAC TAMPONADE WAS NOTICED. THE PATIENT HAD A DROP IN BLOOD PRESSURE WHICH CAUSED THEM TO CHECK FOR ISSUES USING ULTRASOUND. THE CARDIAC TAMPONADE WAS CONFIRMED BY INTRACARDIAC ECHO (ICE). THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 1400CC¿S OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO STEAM POPS OCCURRED BEFORE THE CARDIAC TAMPONADE WAS DISCOVERED AND THERE WAS NO OTHER INDICATION OF ANY ISSUES. THE PHYSICIAN REPORTED TO HAVE THOUGHT THAT THE CS CATHETER MAY HAVE CAUSED A PERFORATION, BUT THIS COULD NOT BE CONFIRMED. THE PATIENT OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED (NO RESIDUAL EFFECTS). THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT IN THE ICU STAY FOR MONITORING. THE GENERATOR USED WAS A SMARTABLATE. AN IRRIG

  Patient problems: Cardiac Tamponade

  MAUDE report 14677032 ↗
• InjuryAug 16, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED BY THE CALLER THAT THE PATIENT SUFFERED A PERICARDIAL EFFUSION IN THE MIDDLE OF THE PROCEDURE- THIS WAS BEFORE ANY ABLATION HAD BEEN PERFORMED. THE PATIENT BECAME HYPOTENSIVE BEFORE THE ABLATION CATHETER (4MM DF CURVE) HAD BEEN INSERTED, AND THEN AN EFFUSION WAS SEEN ON TTE (TRANSTHORACIC) IMAGING. A PERICARDIOCENTESIS WAS PERFORMED, WITH APPROXIMATELY 200 ML OF FLUID REMOVED, WITH A DRAIN LEFT IN PLACE. THE PATIENT WAS STABILIZED, AND THE PROCEDURE WAS CONTINUED AND COMPLETED. THE PATIENT IS CURRENTLY STABLE. THIS ADVERSE EVENT WAS DISCOVERED DURING USE OF BWI PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT: MD SAID IT COULD HAVE BEEN A WIRE OR THE DUODECA CATHETER (60MM SPACING). PATIENT OUTCOME OF THE ADVERSE EVENT WAS UNKNOWN. EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT IS UNKNOWN. A TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. PRIOR TO NOTING THE CT ABLATION WAS NOT PERFORMED. NO EVIDENCE OF STEAM POP. THE EVENT OCCURRED DURING MAPPING PHA

  Patient problems: Cardiac Tamponade

  MAUDE report 12323362 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING TRANSSEPTAL PHASE, PRIOR TO ANY MAPPING OR ABLATION, THE PHYSICIAN NOTICED PERICARDIAL EFFUSION ON INTRACARDIAC ECHO (ICE). THE PATIENT WAS NEVER HEMODYNAMICALLY COMPROMISED. THE EFFUSION WAS MONITORED ON TRANSTHORACIC ECHO (TEE) AND ICE AND SEEMED TO BE GROWING. CARDIAC TAMPONADE WAS CONFIRMED AND PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 275 CC OF FLUID FROM THE PERICARDIAL SPACE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME IS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT OCCURRED WHEN ATTEMPTING TO PLACE THE BWI DUO-DECAPOLAR CATHETER. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BAYLIS TRANSSEPTAL NEEDLE. NO ERROR MESSAGES WERE OBSERVED ON ANY BWI EQUIPMENT DURING THE PROCEDURE. NO EVIDENCE OF STEAM POP. THE CATHETER IRRIGATION WAS SET AT 8-15 ML/MIN AND 2 ML/MIN DURING MAPPING. THE FORCE VISUALIZ

  Patient problems: Cardiac Tamponade

  MAUDE report 8550152 ↗
• InjuryJun 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATYPICAL ATRIAL FLUTTER WITH A WEBSTER CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING PLACEMENT OF THE WEBSTER CATHETER IN THE CORONARY SINUS, THE PHYSICIAN NOTED RESISTANCE FOLLOWED BY RAPID CATHETER ADVANCEMENT. AFTER TRANSSEPTAL PUNCTURE AND LEFT ATRIAL ABLATION, THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER WAS REPOSITIONED TO MORE EFFECTIVELY VISUALIZE THE RIDGE BETWEEN THE LEFT PULMONARY VEINS AND THE LEFT ATRIAL APPENDAGE (LAA). AT THIS POINT, THE RIGHT VENTRICULAR EFFUSION WAS DETECTED. REMAINDER OF PROCEDURE WAS ABORTED. CATHETERS WERE REMOVED FROM THE PATIENT. PERICARDIOCENTESIS YIELDED AN UNSPECIFIED VOLUME OF FLUID. PATIENT REMAINED ASYMPTOMATIC AND STABLE THROUGHOUT THE PROCEDURE. PATIENT WAS TRANSFERRED FOR OBSERVATION. PATIENT REQUIRED EXTENDED HOSPITALIZATION (OVERNIGHT) AS A RESULT OF THE ADVERSE EVENT FOR MONITORING OF THE EFFUSION. PATIENT FULLY RECOVERED. FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE THAT THE PHYSICIAN PUSHED AGAINST THE RESISTANCE OF THE CORONARY SINUS VALVE. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE A

  Patient problems: Cardiac Tamponade

  MAUDE report 7564149 ↗
• MalfunctionOct 12, 2017Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A WEBSTER 20 POLE CATHETER WHERE THE CATHETER BECAME STUCK IN THE FULLY DEFLECTED STATE. DURING THE PROCEDURE, THE CATHETER BECAME STUCK WHILE FULLY DEFLECTED. THE KNOB COULD BE MOVED BY THE PHYSICIAN, BUT THE CATHETER DID NOT MOVE WITH IT. THERE WAS DIFFICULTY REMOVING THE CATHETER, BUT IT WAS ABLE TO BE REMOVED SAFELY FROM THE PATIENT¿S BODY, AND NO PHYSICAL DAMAGE WAS NOTED ON THE CATHETER AFTER REMOVAL. THE CATHETER WAS REPLACED WITH A NEW ONE, AND THE CASE CONTINUED WITHOUT PATIENT CONSEQUENCE. IT WAS NOTED THAT AN UNSPECIFIED DIAGNOSTIC 8.5 FRENCH SHEATH WAS IN USE DURING THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6944871 ↗