WEBSTER D610FR252RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835004335), received between Nov 7, 2022 and Nov 7, 2022 — classified as 2 malfunctions.

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

• MalfunctionNov 7, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER RIGHT (R-AFL) ABLATION PROCEDURE WITH TWO WEBSTER CATHETERS AND IT WAS OBSERVED THAT THERE WAS INTERNAL COMPONENTS EXPOSED ISSUES. IT WAS REPORTED THAT THE WEBSTER (DECANAV) CATHETER HAD A STRANGE KINK ON THE SHAFT OF THE CATHETER ALL THE WAY DISTAL IN BETWEEN THE BIPOLAR ELECTRODE; THE SECTION EVEN ALLOWS FOR THE INTERWORKINGS OF THE CATHETER TO BE SEEN. THE PHYSICIAN REQUESTED TO HAVE THE CATHETER REPLACED. THE REPLACEMENT CATHETER WAS FROM THE SAME LOT NUMBER AND HAD THE SAME ISSUE BETWEEN THE ELECTRODES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE INTERNAL COMPONENTS OF THE CATHETER WERE VISIBLE BUT DID NOT APPEAR TO BE FULLY EXPOSED. NO LIFTED OR SHARP RINGS AS FAR AS THEY COULD TELL. CATHETER WAS NEVER INSERTED INTO A SHEATH; THE DAMAGE WAS RECOGNIZED BEFORE BEING INSERTED INTO THE SHEATH. CATHETER WAS NEVER INSERTED INTO A SHEATH; THE DAMAGE WAS RECOGNIZED BEFORE BEING INSERTED INTO THE SHEATH. TWO DEVICES HAD THIS FAILURE, BUT THEY JUST USED THE SECOND CATHETER. NO VISIBLE DAMAGE ON THE PACKAGING. THE EVENT WAS ASSESSED AS MDR REPORTABLE UNDER BOTH THE WEBSTER CATHETERS FOR IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15749489 ↗
• MalfunctionNov 7, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER RIGHT (R-AFL) ABLATION PROCEDURE WITH TWO WEBSTER CATHETERS AND IT WAS OBSERVED THAT THERE WAS INTERNAL COMPONENTS EXPOSED ISSUES. IT WAS REPORTED THAT THE WEBSTER (DECANAV) CATHETER HAD A STRANGE KINK ON THE SHAFT OF THE CATHETER ALL THE WAY DISTAL IN BETWEEN THE BIPOLAR ELECTRODE; THE SECTION EVEN ALLOWS FOR THE INTERWORKINGS OF THE CATHETER TO BE SEEN. THE PHYSICIAN REQUESTED TO HAVE THE CATHETER REPLACED. THE REPLACEMENT CATHETER WAS FROM THE SAME LOT NUMBER AND HAD THE SAME ISSUE BETWEEN THE ELECTRODES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE INTERNAL COMPONENTS OF THE CATHETER WERE VISIBLE BUT DID NOT APPEAR TO BE FULLY EXPOSED. NO LIFTED OR SHARP RINGS AS FAR AS THEY COULD TELL. CATHETER WAS NEVER INSERTED INTO A SHEATH; THE DAMAGE WAS RECOGNIZED BEFORE BEING INSERTED INTO THE SHEATH. CATHETER WAS NEVER INSERTED INTO A SHEATH; THE DAMAGE WAS RECOGNIZED BEFORE BEING INSERTED INTO THE SHEATH. TWO DEVICES HAD THIS FAILURE, BUT THEY JUST USED THE SECOND CATHETER. NO VISIBLE DAMAGE ON THE PACKAGING. THE EVENT WAS ASSESSED AS MDR REPORTABLE UNDER BOTH THE WEBSTER CATHETERS FOR IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15747393 ↗