WEBSTER F5ADP282RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10846835000467), received between Nov 4, 2021 and Sep 9, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE WITH A WEBSTER AND THE TIP WAS DAMAGED/BROKEN ISSUE OCCURRED. DEVICE DAMAGED. IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE CATHETER WAS BROKEN (AS THE PHOTOS SHOW) WHEN IT WAS INSERTED INTO THE 6F SHEATH. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 18-AUG-2024. THE TIP WAS DAMAGED/BROKEN. INTERNAL MECHANISM EXPOSED. THERE WAS A CRACK AT THE TIP. THERE WAS NO LIFTED OR DAMAGED ELECTRODES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20173900 ↗
• MalfunctionSep 6, 2024Contamination /Decontamination Problem; Communication or Transmission Problem; Contamination /Decontamination Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND THERE WAS FOREIGN MATTER IN THE CONNECTOR. IT WAS REPORTED THAT DURING THE OPERATION, IT WAS FOUND THAT THERE HAD BEEN FOREIGN MATTER IN THE CONNECTOR PIN HOLES OF THE DEVICE, WHICH MADE IT UNABLE TO CONNECT TO THE CABLE PROPERLY. THERE WAS NO ISSUE WITH MANEUVERING OR WITHDRAWING THE CHARACTER. THE CATHETER PEBAX WAS NOT DAMAGED. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20160994 ↗
• MalfunctionAug 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A WEBSTER CATHETER. DURING THE PROCEDURE, THE CATHETER WAS FOUND WITH A SCRATCH ON THE SHAFT (WITH NO EXPOSED WIRE). A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19964296 ↗
• MalfunctionJul 2, 2024Material Separation; Manufacturing, Packaging or Shipping Problem; Material Separation; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER AND A HOLE WAS FOUND IN THE SHAFT OF THE DEVICE. THE DEVICE WAS DAMAGED. IT WAS REPORTED THAT BEFORE THE OPERATION, AFTER THE PACKAGE WAS OPENED, THE SHAFT OF THE CATHETER WAS FOUND WITH A HOLE (WITH NO EXPOSED WIRE). A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19662670 ↗
• MalfunctionNov 4, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN UNKNOWN ABLATION PROCEDURE WITH A WEBSTER COMPLI. THE STERILE PACKAGE WAS NOT INTACT. INTERIOR PACKAGE DAMAGED. IT WAS REPORTED BY PHYSICIAN THAT THE STERILIZATION PACKAGE WAS BROKEN AND PRODUCT WAS DIRTY. SO THEY DIDN¿T USE THE CATHETER IN/ON PATIENT, REPLACED WITH OTHER NEW ONE. NO PATIENT WAS REPORTED INJURED. OPEN POUCH SEAL IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12750207 ↗