WEBSTER F6QA005CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835007886), received between Nov 12, 2021 and Nov 12, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• InjuryNov 12, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ELECTROPHYSIOLOGY (EP) STUDY WITH TWO (2) WEBSTER¿ ELECTROPHYSIOLOGY CATHETER & TWO (2) WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID AND THE PATIENT EXPERIENCED ATRIOVENTRICULAR (AV) HEART BLOCK REQUIRING PERMANENT PACEMAKER IMPLANTATION. DURING AN EP STUDY, THE PATIENT PRESENTED AV BLOCK OF 1 MINUTE. BACK-UP PACING WITH A CATHETER PLACED IN THE RIGHT VENTRICLE (RV) WAS POSSIBLE. AFTER A WAITING PERIOD UNDER PACING, THE PHYSICIAN TESTED IF THE AV CONDUCTION WAS BACK, BUT IT WAS NOT COMPLETELY. SO CONTINUOUS PACING FROM THE RV CATHETER WAS NECESSARY. THE PATIENT UNDERWENT THEN A CORONAROGRAPHY AND A PACING SONDE (TEMPORARY PACEMAKER) WAS IMPLANTED TO ENSURE BACK-UP PACING IN CASE OF AV BLOCK. THERE IS NO FURTHER INFORMATION ABOUT IF PROLONGED HOSPITALIZATION WAS REQUIRED. THE PHYSICIAN OPINION IS THAT IT IS NOT A COMPLICATION DUE TO THE PROCEDURE, BUT A PRE-EXISTING PATIENT-RELATED PROBLEM. NO ABLATION OR ABLATION CATHETER WAS IN USE AT ANY TIME. BASED ON THE INFORMATION INITIALLY PROVIDED, THIS EVENT WAS ASSESSED AS NOT MDR REPORTABLE BASED ON PHYSICIAN¿S OPINION INDICATING THIS WAS A PATIENT RELATED PRE-EXISTING CONDITION

  Patient problems: Heart Block

  MAUDE report 12806609 ↗
• InjuryNov 12, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ELECTROPHYSIOLOGY (EP) STUDY WITH TWO (2) WEBSTER¿ ELECTROPHYSIOLOGY CATHETER & TWO (2) WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID AND THE PATIENT EXPERIENCED ATRIOVENTRICULAR (AV) HEART BLOCK REQUIRING PERMANENT PACEMAKER IMPLANTATION. DURING AN EP STUDY, THE PATIENT PRESENTED AV BLOCK OF 1 MINUTE. BACK-UP PACING WITH A CATHETER PLACED IN THE RIGHT VENTRICLE (RV) WAS POSSIBLE. AFTER A WAITING PERIOD UNDER PACING, THE PHYSICIAN TESTED IF THE AV CONDUCTION WAS BACK, BUT IT WAS NOT COMPLETELY. SO CONTINUOUS PACING FROM THE RV CATHETER WAS NECESSARY. THE PATIENT UNDERWENT THEN A CORONAROGRAPHY AND A PACING SONDE (TEMPORARY PACEMAKER) WAS IMPLANTED TO ENSURE BACK-UP PACING IN CASE OF AV BLOCK. THERE IS NO FURTHER INFORMATION ABOUT IF PROLONGED HOSPITALIZATION WAS REQUIRED. THE PHYSICIAN OPINION IS THAT IT IS NOT A COMPLICATION DUE TO THE PROCEDURE, BUT A PRE-EXISTING PATIENT-RELATED PROBLEM. NO ABLATION OR ABLATION CATHETER WAS IN USE AT ANY TIME. BASED ON THE INFORMATION INITIALLY PROVIDED, THIS EVENT WAS ASSESSED AS NOT MDR REPORTABLE BASED ON PHYSICIAN¿S OPINION INDICATING THIS WAS A PATIENT RELATED PRE-EXISTING CONDITION.

  Patient problems: Heart Block

  MAUDE report 12806522 ↗