Webster CS BD710FJ282RTSRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10846835002430), received between Jul 17, 2018 and Jan 7, 2026 — classified as 1 death, 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K101345); they may or may not involve this specific model.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 7, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A ATRIAL FIBRILLATION (AFIB) IN WHICH THE WEBSTER CS CATHETER HAD AN INNER WIRE EXPOSED OUT OF THE PACKAGING. THE WEBSTER CS CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED USING THE NEW CATHETER. NO PATIENT CONSEQUENCES WERE REPORTED. THE CATHETER DAMAGED CATHETER WAS NEVER PLACED IN THE BODY. THE LOT NUMBER IS NOT AVAILABLE. CRACKED PEEK HOUSING WITH EXPOSED INTERNAL PARTS IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16499993 ↗
• InjuryJun 6, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. DURING THE PROCEDURE, A CARDIAC TAMPONADE WAS NOTICED BEFORE ANY ABLATION HAD OCCURRED. THE PATIENT HAD A DROP IN BLOOD PRESSURE THAT OCCURRED WHEN THEY WERE GETTING READY TO ZERO THE ABLATION CATHETER AND WERE PERFORMING RESPIRATORY TRAINING. THE CARDIAC TAMPONADE WAS CONFIRMED BY AN ECHOCARDIOGRAM. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND JUST OVER 200 CC¿S OF FLUID WERE REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THERE WAS NO INDICATION THROUGHOUT THE CASE OF ANY ISSUES BESIDES THE PATIENT'S DROP IN BLOOD PRESSURE. THE PHYSICIAN BELIEVED THE PERICARDIAL EFFUSION MAY HAVE OCCURRED DUE TO A PERFORATION BY THE WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY. NO ABLATION HAD OCCURRED YET. ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PROCEDURE AND PATIENT CONDITION RELATED. THE PATIENT OUTCOME WAS FULLY RECOVERED. THE GENERATOR THAT WAS INTENDED TO BE USED W

  Patient problems: Cardiac Tamponade

  MAUDE report 14604194 ↗
• MalfunctionJan 28, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER RIGHT (R-AFL) ABLATION PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY AND AN OPEN POUCH SEAL ISSUE OCCURRED. IT WAS REPORTED THAT WHEN OPENING THE CATHETER FOR THE FIRST TIME THE INSIDE WRAPPING WAS OPENED ALREADY AND THE PHYSICIAN DID NOT FEEL LIKE THE CATHETER WAS FULLY STERILE. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE CASE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT. THE PACKAGING WAS OPEN. ALMOST AS IF THERE WAS NO ADHESIVE ON THE OUTER PACKAGING. MEANING IT WAS NOT FULLY SEALED AND THEREFORE, THE PHYSICIAN DID NOT FEEL IT WAS STERILE. THERE WAS NO ISSUE WITH THE WAY IT WAS SEATED IN THE PLASTIC. THE EVENT WAS ASSESSED AS A MDR REPORTABLE OPEN POUCH SEAL ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13388654 ↗
• MalfunctionFeb 5, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION (AFIB) WITH A WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY, AND A FOREIGN MATERIAL ISSUE OCCURRED. IT WAS REPORTED THAT DURING THE ABLATION PROCEDURE, THE DISTAL ELECTRODES OF THE WEBSTER CS CATHETER WERE NOT WORKING, AND THE DISTAL END OF THE CATHETER WAS NOT BEING VISUALIZED ON THE CARTO 3 SYSTEM. IT WAS ALSO NOTED THAT THERE WAS VISIBLE SMALL DEBRIS OF ABOUT 2 MM ON THE DISTAL END OF THE CATHETER WHEN REMOVED FROM THE BODY. NO CHAR OR CLOT WAS OBSERVED. THE PHYSICIAN WIPED OFF THE CATHETER. THERE¿S NO INFORMATION REGARDING HOW THE CASE WAS COMPLETED. IT IS UNKNOWN IF THE DEBRIS WERE PRESENT BEFORE OR AFTER THE CATHETER WAS INTRODUCED INTO THE PATIENT¿S BODY. THE PHYSICIAN DID NOT FEEL ANY RESISTANCE WHILE INTRODUCING OR RETRACTING THE CATHETER FROM THE SHEATH. NO PHYSICAL DAMAGE WAS OBSERVED ON THE DISTAL END OF THE CATHETER. NO PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER DETAILS ARE AVAILABLE. THE OBSERVED FOREIGN MATERIAL HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9674133 ↗
• DeathAug 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE ON WHICH A WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY WAS USED AND SUFFERED CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS) AND DEATH. UPON PROCEDURE COMPLETION BEFORE THE CATHETERS WERE REMOVED, THERE WAS NO EVIDENCE OF PERICARDIAL EFFUSION, THIS WAS CONFIRMED BY ULTRASOUND. 4 HOURS POST-PROCEDURE WHILE THE PATIENT WAS IN THE RECOVERY ROOM, THERE WAS A DROP-IN BLOOD PRESSURE. CARDIAC TAMPONADE WAS CONFIRMED, AND PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIAL SPACE. ULTRASOUND CONFIRMED BLEEDING HAD STOPPED. THE PATIENT WAS STABLE OVERNIGHT; HOWEVER, EXPIRED THE NEXT DAY ((B)(6) 2019). THE PHYSICIAN COULD NOT CONFIRM FOR SURE THAT THE DEATH WAS RELATED TO THE PROCEDURE, CARDIAC TAMPONADE OR OTHER COMORBIDITIES. IT WAS CONFIRMED THAT NO BIOSENSE WEBSTER, INC. REPRESENTATIVE WAS PRESENT FOR THE CASE. THERE¿S NO INFORMATION THAT A THERAPEUTIC BIOSENSE WEBSTER, INC. CATHETER WAS USED DURING THE PROCEDURE. NO BIOSENSE WEBSTER, INC. PRODUCT MALFUNCTIONS WERE REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN CLARIFICATION ON THIS EVENT WITH NO RE

  Patient problems: Cardiac Tamponade; Death

  MAUDE report 8903891 ↗
• InjuryJun 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT ((B)(6)) UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND A WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE MAPPING PHASE THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER WAS POSITIONED TO VISUALIZE THE THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER ABLATION CATHETER IN THE LEFT VENTRICLE (LV), AT THAT TIME, CARDIAC TAMPONADE WAS CONFIRMED BY ECHO. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 237 CC OF FLUID FROM THE PERICARDIAL SPACE. THE PATIENT WAS REPORTED IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. THE PATIENT KEPT OVERNIGHT AND WAS DISCHARGED THE NEXT DAY. PATIENT¿S OUTCOME IS FULLY RECOVERED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED, HE BELIEVED IT OCCURRED EITHER DURING THE TRANSSEPTAL PUNCTURE OR CS CATHETER PLACEMENT. THERE WAS NO EVIDENCE OF STEAM POP NOR CHANGE IN THE IMPEDANCE VALUE THROUGHOUT THE 2 ABLATIONS PERFORMED. THE THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER WAS SET

  Patient problems: Cardiac Tamponade

  MAUDE report 8670280 ↗
• InjuryMar 18, 2019Adverse 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 A LEFT SIDED IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY AND A THERMOCOOL SMART TOUCH SF BIDIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. POST-PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. CARDIAC TAMPONADE WAS CONFIRMED AND PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIAL SPACE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. EXTENDED HOSPITALIZATION WAS NOT REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME WAS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT MIGHT HAVE OCCURRED DUE TO THE WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY (CS) MANIPULATION FOR POST ELECTROPHYSIOLOGY STUDY, AS THE EVENT WAS NOTICED WHEN THE PHYSICIAN TRIED TO REPOSITION THE CS CATHETER. NO ERROR MESSAGES WERE OBSERVED ON ANY BIOSENSE WEBSTER INC. (BWI) EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BRK-1 TRANSSEPTAL NEEDLE. THERE WAS NO EVIDENCE OF STEAM POP DURING TH

  Patient problems: Cardiac Tamponade

  MAUDE report 8430785 ↗
• MalfunctionJul 17, 2018Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY AND A CLOT WAS VISUALIZED ON THE INTRACARDIAC ULTRASOUND. THE CATHETER WAS REMOVED AND THE CASE CONTINUED WITHOUT FURTHER ISSUE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THE SYSTEM DID NOT DISPLAY ANY ERROR MESSAGES AND THE PHYSICIAN DID NOT EXPERIENCE ANY PRODUCT ISSUES DURING THE PROCEDURE. IT WAS ALSO CONFIRMED THAT THE ISSUE DID NOT OCCUR DURING THE ABLATION. HEPARINIZED SALINE ANTICOAGULANT WAS ADMINISTERED TO THE PATIENT. THE PATIENT HAS NOT EXHIBITED ANY NEUROLOGICAL SYMPTOM SINCE THE PROCEDURE WAS COMPLETED. THE CLOT ISSUE HAS BEEN ASSESSED AS A REPORTABLE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7695343 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101345. One submission often covers many models, so check the product and lot details in each record.

• Z-1647-2012 · Dec 15, 2007 · Terminated
  EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter Cardiovascular catheter for use in electrophysiological diagnosis and ablation.