WEBSTER D606DR002RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835004212), received between Mar 16, 2022 and Mar 16, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2022Material Protrusion/Extrusion; Separation Problem; Material Protrusion/Extrusion; Separation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND ISSUES WITH INTERNAL COMPONENTS EXPOSED AS WELL AS A MISSING ELECTRODE OCCURRED. WHEN THE WEBSTER CATHETER WAS TAKEN OUT OF THE PACKAGE, THEY NOTICED THAT A THIRD ELECTRODE WAS MISSING, EXPOSING THE WIRE UNDERNEATH. IT WAS NOT THE ANCHOR WINDOW BUT A WIRE PROTRUDING FROM THE CATHETER ITSELF UPON OPENING. THE CATHETER WAS NOT USED IN THE PATIENT AND NOT INSERTED INTO A DILATOR OR THE SHEATH. THE DAMAGE WAS NOTED UPON OPENING OF THE PACKAGE AND WAS NOT USED IN THE FIELD. THERE WAS NO PHYSICAL DAMAGE TO THE PACKAGING AND THE DEVICE WAS PROPERLY SECURED IN THE TRAY. THE CATHETER WAS REPLACED, AND THE ISSUE RESOLVED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE ISSUES OF INTERNAL COMPONENTS EXPOSED AND THE MISSING ELECTRODE WERE ASSESSED AS A MDR REPORTABLE PRODUCT MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13786326 ↗