WEBSTER F5QF005CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835007305), received between Sep 16, 2020 and Aug 27, 2021 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2021Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available; Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A WEBSTER CATHETER AND A KNOTTED CATHETER ISSUE OCCURRED. RIGHT VENTRICLE CATHETER WAS KNOTTED IN THE VESSEL. IT WAS TOO SOFT ALTHOUGH IT WAS A NEW CATHETER. PHYSICIAN CHANGED THE CATHETER. THE NEW ONE WAS BETTER. NO PATIENT CONSEQUENCE WAS REPORTED. THERE WAS DIFFICULTY EXPERIENCED WHILE MANEUVERING THE CATHETER. THERE WAS NO DETACHMENT OF ANY COMPONENT. THE LOOP/TIP BECAME UNKNOTTED. THE ISSUE DID NOT RESULT IN EXPOSURE OF ANY INTERNAL CATHETER COMPONENTS OR SHARP EDGES. THE KNOTTED CATHETER ISSUE WAS ASSESSED AS A MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12375986 ↗
• MalfunctionSep 16, 2020Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT A PATIENT UNDERWENT CARDIAC ABLATION PROCEDURE FOR ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA/WOLFF-PARKINSON-WHITE (AVRT/WPW) WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER WHEREIN THE CATHETER FORMED A KNOT. RIGHT VENTRICLE (RV) CATHETER GOT ENTANGLED DURING CATHETER PLACEMENT. THE PHYSICIAN USED A DEFLECTABLE SHEATH TO MANEUVER AND UNTANGLE THE RV CATHETER. THERE WAS NO PATIENT CONSEQUENCE AND THE PROCEDURE CONTINUED NORMALLY. ADDITIONAL INFORMATION RECEIVED INDICATED THERE WERE NO EXPOSED INTERNAL COMPONENTS, SHARP OR LIFTED RINGS. NO COMPONENT DETACHMENT OCCURRED. THERE WAS NO RESISTANCE OR DIFFICULTY DURING INSERTION OR REMOVAL OF THE CATHETER BEFORE AND AFTER ENTANGLEMENT. NO REPORT OF EXTENDED HOSPITALIZATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10544365 ↗