WEBSTER F5QA005CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10846835007183), received between Aug 30, 2018 and Mar 28, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN UNKNOWN ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID. THE CATHETER SHAFT WAS DETACHED FROM THE BODY. NO PATIENT CONSEQUENCES WERE REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. CATHETER SHAFT BROKEN WHILE INSIDE PATIENT IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13927290 ↗
• MalfunctionAug 26, 2019Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE BEFORE THE TRANSSEPTAL WAS PERFORMED THE WEBSTER CATHETER FORMED A KNOT. THE CUSTOMER PROVIDED IMAGES CONFIRMING THE REPORT. ONCE THE KNOT FORMED IT WAS VERY HARD TO MANEUVER THE DEVICE. THE KNOTTED CATHETER WAS REMOVED BY USING A LARGER SHEATH (ST. JUDE SLO 10F). THE PROCEDURE WAS CANCELLED. THE PHYSICIAN DID NOT CONSIDER PROCEDURE CANCELLATION MAY HAVE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY TO THE PATIENT. THE PATIENT REMAINED IN OBSERVATION FOR 1 ADDITIONAL DAY. NO PATIENT CONSEQUENCE WAS REPORTED. THE KNOTTED CATHETER WAS ASSESSED AS A REPORTABLE MALFUNCTION. THE PROCEDURE CANCELLATION CANCELATION WAS ASSESSED AS NOT REPORTABLE AS THERE WAS NO RISK TO THE PATIENT AS A RESULT OF THE CANCELLATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8932791 ↗
• MalfunctionAug 30, 2018Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A WEBSTER CATHETER. IT WAS DESCRIBED THAT THE WEBSTER CATHETER WAS VISUALIZED UPSIDE DOWN ON THE CARTO 3 SYSTEM. THE CATHETER CABLE WAS CHANGED, BUT THE ISSUE DID NOT RESOLVE. THE WEBSTER CATHETER WAS CHANGED AND THE ISSUE RESOLVED. THE PROCEDURE WAS CONTINUED AND SUBSEQUENTLY COMPLETED. THE VISUALIZATION ISSUE WAS ASSESSED AS NOT REPORTABLE. THE USER WILL HAVE TO REPLACE THE CATHETER IN ORDER TO COMPLETE THE CASE. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH WAS REMOTE. THE BIOSENSE WEBSTER FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. IT WAS DISCOVERED ON (B)(6) 2018 THAT ELECTRODE RING #2 WAS SHARP AT APPROXIMATELY 1.1 CM FROM THE DISTAL TIP. THE SHARP ELECTRODE WAS ASSESSED AS A REPORTABLE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7831563 ↗