WEBSTER F5QA252RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835007213), received between Aug 13, 2021 and Sep 22, 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.

• InjurySep 22, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE (CT) REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT A PERICARDIAL EFFUSION WAS NOTED POST USE OF BIOSENSE WEBSTER PRODUCTS. THE CAUSE IS UNKNOWN; HOWEVER, THE PHYSICIAN'S OPINION ON THE CAUSE IS THAT IT IS PROCEDURE RELATED AND NOT CATHETER RELATED. A PERICARDIAL PUNCTURE WAS PERFORMED TO DRAIN BLOOD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS REPORTED AS ¿IMPROVED, ON THAT DAY, NO FURTHER INFORMATION AT THE MOMENT¿. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION FOR MONITORING. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH AN ABBOTT BRK NEEDLE. PRIOR TO NOTING THE CT, ABLATION WAS PERFORMED. THERE WAS NO EVIDENCE OF A STEAM POP. IT IS UNKNOWN AT WHAT PHASE THE EVENT OCCURRED; HOWEVER, IT WAS DETECTED POST PROCEDURE. AN IRRIGATED CATHETER WAS USED IN THE EVENT AND THE FLOW SETTINGS WERE: 8ML/MIN UP TO 30W, 15ML/MIN ABOVE 30W. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE PUMP WAS SWITCHING FROM LOW TO HIGH FLOW DURING ABLATION. NO ERROR MESSAGES WERE OBSER

  Patient problems: Cardiac Tamponade

  MAUDE report 12513575 ↗
• InjuryAug 13, 2021Break; Material Twisted/Bent; Patient Device Interaction Problem; Break; Material Twisted/Bent; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ELECTROPHYSIOLOGICAL EXAMINATION PROCEDURE WITH A WEBSTER CATHETER. THE CATHETER TIP BROKE AND BECAME KNOTTED AND ULTIMATELY HAD TO BE SURGICALLY REMOVED. THE WEBSTER CATHETER WAS INSERTED INTO THE VENA FEMORALIS FOR A DIAGNOSTIC ELECTROPHYSIOLOGY PROCEDURE. DURING THE PROCEDURE, THE CATHETER TIP BROKE AFTER HAVING VASCULAR WALL CONTACT. THE BROKEN POSITION WAS VISIBLE UNDER FLUOROSCOPY. THE PHYSICIAN TRIED TO RETRIEVE THE CATHETER, BUT DUE TO THE BROKEN TIP IT WAS NOT POSSIBLE TO REMOVE THE CATHETER FROM THE VEIN. TWISTING AND PULLING THE CATHETER RESULTED IN BECOMING KNOTTED AND ULTIMATELY HAVING TO BE SURGICALLY REMOVED. THE VENA FEMORALIS HAD TO BE OPENED COMPLETELY IN THE AREA OF THE GROIN., THIS ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER, INC. (BWI) PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS A BWI PRODUCT MALFUNCTION. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE NECESSARY ADDITIONAL SURGICAL INTERVENTION TO REMOVE THE CATHETER FROM THE VEIN. HEALING TIME AND LENGTH OF STAY IN HOSPITAL WAS EXTENDED. A THERMOCOOL® SMARTTOUCH® SF CATHETER WAS NOT USED. NO ABLATI

  Patient problems: Perforation of Vessels

  MAUDE report 12320939 ↗