WEBSTER CS D135304Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10846835009989), received between Nov 15, 2018 and Jan 16, 2026 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryDec 30, 2024Entrapment of Device; Material Deformation; Material Protrusion/Extrusion; Patient Device Interaction Problem; Entrapment of Device; Material Deformation; Material Protrusion/Extrusion; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND THE DEVICE WAS INSERTED INTO THE SHEATH AND PUSHED UP THE VEIN. THE CATHETER SLIPPED INTO THE HEPATIC VEIN WHERE IT GOT STUCK. IT COULD NOT BE WITHDRAWN AGAIN. THE CATHETER WAS CUT OPEN AND THEN PULLED OUT. AFTER VISUAL INSPECTION, A SMALL BUMP WAS FOUND ON THE CATHETER ELECTRODES, WHICH MAY HAVE LED TO THE SNAGGING. THE PROCEDURE HAD TO BE CANCELLED. THE CATHETER COULD BE COMPLETELY REMOVED. THE PATIENT WAS NOT HARMED. PATIENT WAS TREATED ON THE NEXT DAY WITH ABLATION AND THE PROCEDURE WAS SUCCESSFULLY FINALIZED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 21044486 ↗
• MalfunctionJun 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WHICH INCLUDED A WEBSTER CORONARY SINUS (CS) CATHETER WITH AUTO ID TECHNOLOGY AND AT THE END OF THE CASE, THE SMALL FEMORAL SHEATH BROKE IN 2 PIECES. THE CS CATHETER WAS REMOVED WITH NO ISSUE AS IT CAME OUT FREELY. IT WAS NOTED THAT ON THE CS ITSELF, THERE WAS A SMALL NICK ALONG THE CATHETER (MINISCULE TRIANGLE CUT). THE PHYSICIAN IS NOT 100% SURE IF THE CATHETER BROKE INSIDE THE PATIENT AND BELIEVED THAT IT MAY HAVE HAPPENED WHEN PULLING BACK THROUGH THE BROKEN FEMORAL SHEATH. PART FROM SHEATH WAS REMOVED WITH NO PROBLEM POST PROCEDURE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19472509 ↗
• MalfunctionNov 10, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION PROCEDURE WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND A DEFLECTION ISSUE OCCURRED WHICH MADE THE REMOVAL FROM THE PATIENT DIFFICULT. THE CATHETER DID NOT RESPOND WELL TO DEFLECTION AND THE MOVEMENTS CREATED WERE NOT THOSE DESIRED. THE DEVICE WAS VERY "SOFT" AS SOON AS IT WAS INTRODUCED INTO THE FEMORAL DESILET AND ROLLED UP ON ITSELF MAKING ITS USE IMPOSSIBLE AND ITS REMOVAL FROM THE PATIENT DIFFICULT (REFUSING TO UNROLL THE DOCTOR RISKED DAMAGING THE FEMORAL VEIN). THE DOCTOR MANAGED TO REMOVE THE DEVICE WITHOUT DAMAGING THE VEIN AND USED ANOTHER DEVICE TO CONTINUE THE PROCEDURE. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18116929 ↗
• MalfunctionJun 22, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND THE DEFLECTION BECAME STUCK. THE WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY CATHETER WAS NOT STEERABLE ANYMORE. THE CURVE WENT SMALLER AND THE PHYSICIAN COULD NOT STEER THE CATHETER BACK TO ORIGINAL POSITION. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THERE WAS NO SURGERY DELAY AND NO FRAGMENTS WERE GENERATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17181194 ↗
• MalfunctionNov 8, 2022Entrapment of Device; Material Twisted/Bent; Entrapment of Device; Material Twisted/Bent

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN AFIB ¿ PAROXYSMAL ABLATION PROCEDURE WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY. THE CATHETER PROBE BECAME WRAPPED AROUND THE GUIDEWIRE. THE EVENT OCCURRED DURING THE PROCEDURE, BEFORE THE TRANSEPTAL. AFTER POSITIONING THE DECAPOLAR PROBE (WEBSTER CS CATHETER) IN THE HEART, THE DOCTOR NOTICED THAT THE PROBE HAS WRAPPED AROUND THE GUIDEWIRE USED FOR THE TRANSEPTAL. THE DOCTOR HAD TO REMOVE THE GUIDEWIRE TO UNROLL THE DECAPOLAR PROBE. NO CONSEQUENCES FOR THE PATIENT. THEY HAD TO CHANGE THE DECAPOLAR PROBE WITH A NEW SIMILAR ONE, BECAUSE THE SHAFT OF THE PROBE WAS TWISTED BECAUSE OF THIS EVENT. SURGERY WAS DELAYED FOR 5 MINS DUE TO THE REPORTED EVENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENTS¿ CONSEQUENCES. THE PROBE GOT TANGLED IN THE TRANSEPTAL GUIDE, ALMOST TIED A KNOT. THE PROCEDURE WAS NOT STOPPED THE TECHNICAL SURGERY WAS NOT CHANGED. THE DAMAGE DID NOT RESULT IN WIRES BEING EXPOSED OR IN ANY LIFTED OR SHARP RINGS. THERE WAS NO RESISTANCE DURING INSERTION, BUT THERE WAS RESISTANCE WHEN THE DOCTOR WAS TRYING TO REMOVE THE CATHETER FROM THE PATIENT BECAUSE IT WAS WRAPPED AROUND THE GUIDEWIRE USED FOR THE TRANSEPT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15754114 ↗
• MalfunctionAug 2, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND A BROKEN TIP ISSUE OCCURRED. IT WAS REPORTED THAT THE PULLER WIRE OR SOME SORT OF INTERNAL COMPONENT WAS PROTRUDING OUT OF THE TIP OF THE CATHETER. THE FELLOW HAD PARTIALLY INSERTED IT WHEN THE CONSULTANT ASKED FOR IT TO BE PULLED BACK SO HE COULD SEE THE TIP. THERE WAS NO DIFFICULTY EXPERIENCED WHILE MANEUVERING THE CATHETER, IT WAS BARELY INSERTED. THE DAMAGE DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. THE CATHETER WAS SWAPPED FOR A NEW CATHETER. THERE WAS NO PATIENT CONSEQUENCE, AND THE PROCEDURE WAS NOT EXTENDED GREATER THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15143597 ↗
• MalfunctionDec 27, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT ¿ LEFT) ABLATION PROCEDURE WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND THE CATHETER BREAKAGE OCCURRED. IT WAS REPORTED THAT DURING USE OF THE WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY, THE CATHETER BROKE WHEN THE PHYSICIAN INTRODUCED IT INTO CORONARY SINUS AND THE CATHETER COULD NOT BE SEEN AFTER THIS DAMAGE. THE PROCEDURE WAS DELAYED 2 MINUTES AND A NEW CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. ADDITIONAL EXAMS HAVE BEEN DONE (SCANNER) AND WAITING FOR RESULTS. ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATING THE DAMAGE RESULTED IN WIRES AND/OR BRAID BEING EXPOSED; THE PHYSICIAN SAW WIRES. IT IS UNKNOWN IF THE DAMAGE RESULTED IN ANY LIFTED OR SHARP RINGS. THE PHYSICIAN DID NOT NOTICE ANY RESISTANCE OR DIFFICULTY DURING INSERTION OR REMOVAL OF THE DEVICE. THERE WAS NO LOSS OF MATERIAL. NO PART WAS DETACHED JUST CATHETER BREAK UP WITHOUT LOSS OF MATERIAL. THE PHYSICIAN DIDN¿T USE A SHEATH FOR THIS CATHETER. A COMPUTED TOMOGRAPHY (CT) SCAN HAS BEEN DONE BUT IT WAS NORMAL. PHYSICIAN¿S OPINION ON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13091167 ↗
• InjuryDec 31, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT (FEMALE, (B)(6)) UNDERWENT CARDIAC ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT WHILE PERFORMING A TRANSSEPTAL PUNCTURE, THE PATIENT COUGHED DEEPLY. THE CALLER RESET VISUALIZATION, AND THE PROCEDURE WAS CONTINUED. THE PHYSICIAN CONTINUED WITH TRANSEPTAL ACCESS. THE CALLER TOLD THE PHYSICIAN THAT THEY WERE HAVING TROUBLE SEEING THE TRANSSEPTAL SHEATH, AND WAS ADVISING ON THE STRUCTURES THAT WERE SEEN ON INTRACARDIAC ECHO (ICE). CALLER DID NOT ADVISE THE PHYSICIAN OF WHERE TO PERFORM THE TRANSSEPTAL PUNCTURE. THE CALLER NOTED A DROP IN BLOOD PRESSURE, AND ALERTED THE STAFF. THE PHYSICIAN THEN NOTED A LARGE EFFUSION ON ICE. ABLATION PROCEDURE WAS ABORTED. THE PATIENT WAS TRANSPORTED TO THE OPERATION ROOM FOR A PERICARDIAL WINDOW. PATIENT IS IN STABLE CONDITION AT THIS TIME. SL1 SHEATH USED FOR TS ACCESS, WITH A BRK 71CM NEEDLE. BIOSENSE PRODUCTS THAT WERE IN USE WERE SOUNDSTAR AND CS CATHETERS IN THE BODY, PENTARAY OPENED BUT NOT INSERTED. THE PHYSICIAN STATED THAT THE DEEP COUGH MAY HAVE CAUSED THE EVENT. NO ABLATIO

  Patient problems: Cardiac Tamponade

  MAUDE report 11103328 ↗
• MalfunctionNov 17, 2020Material Puncture/Hole; Tear, Rip or Hole in Device Packaging; Material Puncture/Hole; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT CARDIAC ABLATION FOR ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY WHERE PUNCTURED POUCH OCCURRED. IT WAS REPORTED THAT THE WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY CLEAR PLASTIC PACKAGING WAS PUNCTURED NEAR THE HANDLE OF THE CATHETER. THERE WAS NO CONFIRMATION WHETHER THE PUNCTURE WENT ALL THE WAY THROUGH THE PACKAGING. THE CATHETER WAS NOT USED AND WAS REPLACED. THE PROCEDURE CONTINUED. THERE WAS NO REPORT OF PATIENT CONSEQUENCE. AN IMAGE WAS RECEIVED BY BWI, WHICH SHOWS A POTENTIAL PERFORATION OF THE STERILE POUCH. A PUNCTURED POUCH IS AN MDR-REPORTABLE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10852487 ↗
• InjuryMar 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER, WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND LASSO® NAV ECO VARIABLE CATHETER WITH CRYO TECHNOLOGY AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THE PHYSICIAN HAD PROBLEMS TO ACHIEVE THE VEINS, HE ONLY COULD ISOLATE THE RIGHT SUPERIOR PULMONARY VEIN (RSPV), HE APPLIED CRYO EVERYWHERE WITH THE INTENTION TO ISOLATE THE OTHER VEINS. IN FRONT OF THIS DIFFICULTY, HE DECIDED TO USE A LASSO® NAV ECO VARIABLE CATHETER AND THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER. A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY WAS ALSO IN USE DURING CRYO APPLICATIONS. DURING MAPPING WITH CARTO AND BIOSENSE WEBSTER, INC. (BWI) CATHETERS, THE PATIENT BECAME HYPOTENSIVE. CARDIAC TAMPONADE WAS CONFIRMED. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE THE BLOOD ACCUMULATED AROUND THE HEART, BLOOD INFUSION WAS ALSO PROVIDED. THE PATIENT STAYED OVERNIGHT FOR MONITORING PURPOSES. PATIENT¿S OUTCOME IS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT MIGHT HAPPEN

  Patient problems: Cardiac Tamponade

  MAUDE report 8460840 ↗
• MalfunctionNov 15, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT)/(WPW) PROCEDURE WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND FOREIGN MATERIAL WAS FOUND ON THE TIP OF THE CATHETER. THE PHYSICIAN PERFORMED AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA PROCEDURE POST IN THE RIGHT ATRIUM. AT THE END OF THE PROCEDURE, THE PHYSICIAN TOOK OUT THE CATHETERS AND NOTED THAT SOMETHING WAS ATTACHED TO THE TIP PROXIMAL PART OF THE DISTAL ELECTRODE OF THE WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY. THE PHYSICIAN TRIED TO PULL THE UNKNOWN MATERIAL BACK; HOWEVER, IT STAYED ATTACHED. THE PHYSICIAN¿S OPINION WAS THAT THIS UNKNOWN MATERIAL ATTACHED AT THE PROXIMAL PART OF THE DISTAL ELECTRODE WAS A WIRE FROM THE CATHETER ITSELF. THE CATHETER WAS THEN BEING HANDED OVER TO THE BIOSENSE WEBSTER FIELD REPRESENTATIVE AND THIS UNKNOWN MATERIAL FELL OFF OF THE CATHETER. THERE WAS NO PATIENT CONSEQUENCE REPORTED. AFTER REVIEWING THE INFORMATION,THE PICTURE PROVIDED OF THE CATHETER AND THE UNKNOWN MATERIAL, THIS UNKNOWN MATERIAL WAS ASSESSED AS FOREIGN MATERIAL AND HAS BEEN ASSESSED AS A REPORTABLE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8076065 ↗