EPstar Fixed Electrophysiology Catheter DCF-2-8-55-130Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00685447003748), received between Nov 10, 2020 and Dec 11, 2024 — classified as 1 death, 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• DeathDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT DEATH OCCURRED. DURING A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE, AN EPSTAR CATHETER WAS SELECTED FOR USE. THE PATIENT WAS HAVING INFREQUENT PVC. ISUPREL WAS GIVEN TO INCREASE THE FREQUENCY TO MAP WITH A NON-BOSTON SCIENTIFIC MAPPING SYSTEM. THE SYSTEM WAS MAPPED WITH NON-BOSTON SCIENTIFIC CATHETERS. THE PHYSICIAN WAS NOT HAPPY WITH THE ENDOCARDIAL LOCATIONS IN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT AND RIGHT VENTRICULAR OUTFLOW TRACT (RVOT), HENCE DECIDED TO USE THE CATHETER THROUGH A NON-BOSTON SCIENTIFIC LAMP SHEATH TO CANULATE THE CORONARY SINUS (CS) WITH SOME CHALLENGING ANATOMY. THE PHYSICIAN THEN PROCEEDED TO EXCHANGE THE CATHETER FOR A 4FR SHEATH. THE PHYSICIAN THEN PUT THE 2FR EPSTAR CATHETER THROUGH THE SHEATH TO MAP THE SEPTAL BRANCHES. THE PHYSICIAN CANNULATED SEVERAL BRANCHES BUT NONE OF INTEREST TO THE PVC FOCUS. THE EPSTAR WAS REMOVED. THE PHYSICIAN PROCEEDED TO TRY AND MANIPULATE THE LAMP SHEATH TO AIM AT DIFFERENT BRANCHES OF THE ANTERIOR INTER VENTRICULAR VEINS. THE LAMP SHEATH CAME OUT. THE PHYSICIAN THEN REMOVED THE 4FR SHEATH. THEY PROCEEDED TO LOOK AT THE RVOT FOR PVCS AGAIN TO SEE IF ENDOCARDIAL ABLATION IS POSSI

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 20907030 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE USING THE EPSTAR FIXED ELECTROPHYSIOLOGY CATHETER, SUREFLEX STEERABLE GUIDING SHEET, TERUMO GUIDE CATHETER AND DECA CATHETER, THE PROCEDURE WAS ABORTED DUE TO PERICARDIAL EFFUSION REQUIRING INTERVENTION. THE PATIENT WAS STABILIZED AND EVENTUALLY DISCHARGED. THERE IS NO EVIDENCE TO SUGGEST THE BAYLIS MEDICAL DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED COMPLICATIONS. HOWEVER, AS BAYLIS DEVICES WERE AMONG THE SEVERAL DEVICES USED IN THE PROCEDURES, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. A SEPARATE MEDICAL DEVICE PROBLEM REPORT HAS BEEN SUBMITTED FOR THE SUREFLEX STEERABLE GUIDING SHEATH.

  Patient problems: Pericardial Effusion

  MAUDE report 10817140 ↗