SureFlex Steerable Guiding Sheath TSK85-32-BD-71M (UDI 00685447004615)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00685447004615), received between Dec 5, 2019 and Nov 10, 2020 — classified as 2 injuries.

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.

• 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 SUREFLEX STEERABLE GUIDING SHEATH, EPSTAR FIXED ELECTROPHYSIOLOGY CATHETER, 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 EPSTAR FIXED ELECTROPHYSIOLOGY CATHETER

  Patient problems: Pericardial Effusion

  MAUDE report 10817118 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE IN WHICH THE SUREFLEX STEERABLE GUIDING SHEATH KIT WAS USED, IT WAS SUSPECTED THAT A PERICARDIAL EFFUSION OCCURRED. THE STEERABLE SHEATH WAS USED FOR THE TRANSSEPTAL PORTION OF AN ATRIAL FIBRILLATION PROCEDURE. TRANSSEPTAL ACCESS WAS SUCCESSFULLY ACHIEVED AND THE PHYSICIAN MOVED ON TO THE MAPPING PORTION OF THE PROCEDURE. AFTER MAPPING FOR APPROXIMATELY 10 MINUTES, THE PATIENT'S BLOOD PRESSURE STARTED DROPPING AND THERE WAS THOUGHT TO BE A POSSIBLE PERICARDIAL EFFUSION. A FEW WEEKS AFTER THE PROCEDURE, THE PATIENT WAS REPORTED TO BE DOING WELL AND HAD BEEN DISCHARGED FROM THE HOSPITAL. THERE IS NO EVIDENCE TO SUGGEST THAT A BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS BAYLIS MEDICAL DEVICES WERE REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT.

  Patient problems: Pericardial Effusion

  MAUDE report 9417570 ↗