NA RD135303Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888551039499), received between Nov 2, 2023 and Mar 13, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PULSE FIELD ABLATION ATRIAL FIBRILLATION PROCEDURE WITH A REPROCESSED WEBSTER CS (CORONARY SINUS) CATHETER, AND THE PATIENT EXPERIENCED PERFORATION TREATED WITH PERICARDIOCENTESIS. A PERICARDIAL EFFUSION WAS DIAGNOSED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE) POST-TRANSSEPTAL ACCESS. PERICARDIOCENTESIS WAS PERFORMED BY THE PHYSICIAN REMOVING 130 ML OF FLUID. THE CASE WAS ABORTED. THE PATIENT WAS STABLE AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR OBSERVATION TO MONITOR THE DRAIN OVERNIGHT. THERE WAS NO ABLATION PRIOR TO THE ADVERSE EVENT. THE CATHETERS INSIDE THE PATIENT WHEN THE PERICARDIAL EFFUSION WAS DISCOVERED WERE WEBSTER CS CATHETER AND REPROCESSED 8FR GE SOUNDSTAR CATHETER. THE OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS CS PERFORATION, OPERATOR ERROR, AND PROCEDURE.

  Patient problems: Cardiac Perforation

  MAUDE report 24591956 ↗
• MalfunctionSep 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE AND AFTER VISUALLY INSPECTING THE REPROCESSED EP CATHETER WEBSTER CS UNI-DIRECTIONAL DECAPOLAR OUT OF THE PACKAGE, THE TIP ELECTRODE WAS NOTICED TO BE COMING OFF AND WAS ONLY HELD ON BY THE INTERNAL WIRE. THERE WAS NO DAMAGE TO THE PACKAGING. PACKAGING BOX WAS ONLY OPENED IMMEDIATELY PRIOR TO CASE DURING SETUP. THE CATHETER WAS REPLACED, AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23077041 ↗
• MalfunctionDec 27, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT SIDED ATRIAL FLUTTER ABLATION PROCEDURE WITH A REPROCESSED WEBSTER CS CATHETER AND WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE, THERE WAS A CURVE ON THE TIP OF THE CATHETER. THE REPROCESSED WEBSTER CS CATHETER WAS REPLACED, AND THE ISSUE RESOLVED. THERE WAS NO LIFTED OR SHARP RINGS AND/OR BRAID EXPOSED. IN ADDITION, THERE WAS NO PHYSICAL DAMAGE OBSERVED ON THE PACKAGE. CATHETER WAS NOT INSERTED INTO BODY. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. THIS EVENT WAS ORIGINALLY NOT MDR REPORTABLE. HOWEVER, THE DEVICE WAS RETURNED TO STERILMED FOR FURTHER EVALUATION AND A SHARP CUT WAS NOTED ON THE CATHETER TIP 4CM FROM THE DISTAL END. THE CUT WAS NOT NOTED BY THE PHYSICIAN, HE JUST NOTICED A CURVE. THIS CUT IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18399888 ↗
• InjuryNov 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WPW (WOLFF-PARKINSON-WHITE) ABLATION PROCEDURE USING A REPROCESSED WEBSTER CS CATHETER. THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. WHILE PERFORMING A WPW PROCEDURE AT THE END OF THE CASE, IT WAS NOTICED THAT THE PATIENT'S BLOOD PRESSURE WAS LOW. THE PHYSICIAN DISCOVERED AND CONFIRMED A PERICARDIAL EFFUSION USING INTRACARDIAC ECHOCARDIOGRAM AND THE ULTRASOUND CATHETER. THE CARDIOVASCULAR SURGEON WAS CALLED IN AND THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND THEY REMOVED 500 CC'S OF FLUID. THE PATIENT WAS STABLE. THE PHYSICIAN BELIEVED THAT THE PLACEMENT OF THE REPROCESSED CS CATHETER WAS INCORRECT AND COULD HAVE CAUSED THE EFFUSION. THE PHYSICIAN HAD CHANGED THE PLACEMENT OF THE CATHETER AFTER THEIR LAST ABLATION BURN FOR A BETTER SIGNAL AND COULD HAVE CAUSED THE PERFORATION FROM THE PLACEMENT. PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT OVERNIGHT. TRANSSEPTAL PUNCTURE WAS PERFORMED. ABLATION WAS PERFORMED PRIOR TO NOTING THE PERICARDIAL EFFUSION. THE EVENT OCCURRED POST TRANSSEPTAL, POST LAST ABLATION OF LEFT PATHWAY WPW. NO CARDIOVASCULAR SURGERY WAS PERF

  Patient problems: Cardiac Tamponade

  MAUDE report 18059557 ↗