WEBSTER F6ADP282RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835007534), received between Feb 14, 2023 and Jul 26, 2023 — classified as 2 malfunctions.

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

• MalfunctionJul 26, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT A AFIB - PAROXYSMAL ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER, HOWEVER, PRIOR TO THE OPERATION, THE TIP OF THE CATHETER WAS FOUND DAMAGED (NO EXPOSED WIRES). A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. DEVICE WAS NOT USED IN PATIENT. THE DAMAGED TIP IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398974 ↗
• MalfunctionFeb 14, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND THE BIOSENSE WEBSTER, INC PRODUCT ANALYSIS LAB OBSERVED ELECTRODES CRUSHED AND NO RESIDUES OF PU (POLYURETHANE) ON THE EDGE. INITIALLY IT WAS REPORTED THAT BEFORE THE PROCEDURE, AFTER UNPACKING THE PACKAGE, IT WAS FOUND THAT THE FIFTH AND THE SIXTH ELECTRODE HAD BEEN THINNER THAN OTHER NORMAL ELECTRODES (PROVIDED A PHOTO). A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO PHYSICAL DAMAGE TO THE OUTER BOX OR PACKAGING. THE DEVICE WAS SECURED PROPERLY IN THE TRAY. THERE WAS NO DAMAGE TO THE DEVICE DUE TO ANY PART OF THE PACKAGING BEING DAMAGED. ALL PACKAGING WILL BE SHIPPED. CATHETER WAS NOT PRE-SHAPED AND WAS NOT USED IN THE PATIENT. THE ISSUE DID NOT RESULT IN EXPOSURE OF ANY INTERNAL COMPONENTS OR ANY LIFTED OR SHARP EDGES. THE EVENT WAS ASSESSED AS NOT MDR REPORTABLE FOR AN ELECTRODE DAMAGED WITHOUT FOREIGN MATERIAL WITHOUT SHARP OR ROUGH EDGES. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16376595 ↗