WEBSTER D708DR002RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10846835000269), received between Mar 27, 2018 and Jan 12, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Issue” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND THE CATHETER KINKED RESULTING IN A BREAKAGE WHICH EXPOSED INTERNAL WIRING. IT WAS REPORTED THAT UPON ADVANCING THE WEBSTER¿ ELECTROPHYSIOLOGY CATHETER, IT DID NOT ADVANCE CORRECTLY INTO THE ZONE ON THE CARTO 3 SYSTEM. WHEN THE CATHETER WAS REMOVED FROM THE BODY THEY NOTICED THE CATHETER LOOP HAD KINKED AND THE INSULATION WAS BROKEN. THE DAMAGE WAS NOT NOTICED BEFORE THE CATHETER BEING INSERTED INTO THE BODY. THE CATHETER WAS REPLACED USING THE SAME SHEATH TO RESOLVE THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE INSULATION WAS BROKEN, AND THERE APPEARED TO BE EXPOSED WIRES. THE DAMAGE DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. THE CATHETER PROLAPSED WITHIN THE VESSEL AND EVENTUALLY DOUBLED BACK SUPERIORLY. THE CATHETER WAS NOT PRE-SHAPED, THE PHYSICIAN ATTEMPTED TO ADVANCE THE CATHETER THE SAME AS SHE ALWAYS DOES BUT THERE WAS DIFFICULTY DURING INSERTION. THE SHEATH USED WAS A FASTCATH 7F SHORT SHEATH (NON-BWI).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13237884 ↗
• MalfunctionMar 27, 2018Material Frayed; Device Issue; Material Frayed; Device Issue

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER LEFT (L-AFL) PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER. IT WAS REPORTED THAT THE CATHETER WAS NOT DEFLECTING PROPERLY DUE TO A DEFECTIVE PULLER WIRE. IT WAS ALSO REPORTED THAT SOME OF THE INSULATION OF THE CATHETER WAS EXPOSED. THE CATHETER WAS REPLACED AND THE DEFLECTION ISSUE REMAINED. THE CATHETER WAS REPLACED AGAIN AND THE ISSUE RESOLVED. NO PATIENT CONSEQUENCE WAS REPORTED. THE RESPONSE RECEIVED CONFIRMED THAT THE PHYSICIAN REPORTED THAT HE RUBBED WITH HIS GLOVED FINGER AN ELECTRODE RING ON BOTH CATHETERS AND FELT SHARP EDGES. THE ISSUE WAS OBSERVED PRIOR TO INSERTION INTO THE BODY UPON REMOVAL FROM STERILE PACKAGE. IT WAS ALSO CONFIRMED THAT THE INSULATION EXPOSED WAS OBSERVED PROXIMAL TO THE DISTAL PAIR OF ELECTRODES. THE CATHETER WAS NOT PRE-SHAPED. THE DEFLECTION ISSUE WAS ASSESSED AS NOT REPORTABLE. SINCE THE CATHETER IS UNABLE TO DEFLECT OR RELAX COMPLETELY, THE USER WILL NOT BE ABLE TO USE THE DEVICE AND WILL HAVE TO REPLACE IT. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS DETERIORATION IN STATE OF HEALTH WAS REMOTE. THE SHARP RING EDGES AND INSULATION EXPOSED ISSUES WERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7374656 ↗
• MalfunctionMar 27, 2018Material Frayed; Device Issue; Material Frayed; Device Issue

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER LEFT (L-AFL) PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER. IT WAS REPORTED THAT THE CATHETER WAS NOT DEFLECTING PROPERLY DUE TO A DEFECTIVE PULLER WIRE. IT WAS ALSO REPORTED THAT SOME OF THE INSULATION OF THE CATHETER WAS EXPOSED. THE CATHETER WAS REPLACED AND THE DEFLECTION ISSUE REMAINED. THE CATHETER WAS REPLACED AGAIN AND THE ISSUE RESOLVED. NO PATIENT CONSEQUENCE WAS REPORTED. THE RESPONSE RECEIVED CONFIRMED THAT THE PHYSICIAN REPORTED THAT HE RUBBED WITH HIS GLOVED FINGER AN ELECTRODE RING ON BOTH CATHETERS AND FELT SHARP EDGES. THE ISSUE WAS OBSERVED PRIOR TO INSERTION INTO THE BODY UPON REMOVAL FROM STERILE PACKAGE. IT WAS ALSO CONFIRMED THAT THE INSULATION EXPOSED WAS OBSERVED PROXIMAL TO THE DISTAL PAIR OF ELECTRODES. THE CATHETER WAS NOT PRE-SHAPED. THE DEFLECTION ISSUE WAS ASSESSED AS NOT REPORTABLE. SINCE THE CATHETER IS UNABLE TO DEFLECT OR RELAX COMPLETELY, THE USER WILL NOT BE ABLE TO USE THE DEVICE AND WILL HAVE TO REPLACE IT. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS DETERIORATION IN STATE OF HEALTH WAS REMOTE. THE SHARP RING EDGES AND INSULATION EXPOSED ISSUES WERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7374588 ↗