WEBSTER F6QA252RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835007909), received between Sep 28, 2017 and Sep 12, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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.

• MalfunctionSep 12, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER. THE CATHETER SHAFT BROKE. DURING AN AVNRT PROCEDURE, WHILE ADVANCING THE MAPPING CATHETER TO THE PATIENT'S HEART, THE CATHETER SHAFT BROKE AND COULD NOT BE SITUATED IN THE PATIENT'S HEART. A SIMILAR CATHETER WAS OPEN AND THE PROCEDURE CONTINUE AND ENDED SUCCESSFULLY. NO PATIENT CONSEQUENCES. THE DAMAGE DID NOT RESULT IN WIRES BEING EXPOSED OR ANY LIFTED OR SHARP RINGS. THERE WAS NO RESISTANCE OR DIFFICULTY DURING INSERTION OR REMOVAL OF THE CATHETER. THE CATHETER WAS NOT PRE-SHAPED. THE SHEATH WAS A 6F. THE CATHETER SHAFT BREAKING WHILE INSIDE OF THE PATIENT IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457990 ↗
• InjurySep 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR VENTRICULAR TACHYCARDIA WITH A WEBSTER QUADRAPOLAR CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING MAPPING PHASE, A PERICARDIAL EFFUSION WAS DETECTED. PERICARDIOCENTESIS YIELDED AN UNSPECIFIED AMOUNT OF FLUID. REMAINDER OF PROCEDURE WAS ABORTED. PATIENT REQUIRED A FEW DAYS OF HOSPITALIZATION FOR OBSERVATION AS A RESULT OF THE ADVERSE EVENT. PATIENT OUTCOME IS IMPROVED. FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE PATIENT MOVEMENT WHILE SEDATED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO PROCEDURE AND PATIENT CONDITION. IT WAS NOTED THAT THE PHYSICIAN CONCLUDED THAT THE RVA (RIGHT VENTRICULAR APEX) WEBSTER QUADRAPOLAR CATHETER MOST LIKELY PERFORATED THE WALL AS A RESULT OF THE PATIENT¿S MOVEMENT. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK XS SERIES TRANSSEPTAL NEEDLE. SHEATHS IN USE INCLUDED A ST JUDE MEDICAL AGILIS STEERABLE INTRODUCER AND A ST. JUDE MEDICAL SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER. GENERATOR WAS SET ON POWER CONTROL MODE AT 35 WATTS WITH A TEMPERATURE CUT-OFF OF 40 DEGREES CEL

  Patient problems: Cardiac Tamponade

  MAUDE report 6901820 ↗