TorFlex Transseptal Guiding Sheath TF85-32-63-45 (UDI 00685447000693)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00685447000693), received between Mar 26, 2019 and Feb 4, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CASE OF PERICARDIAL EFFUSION WAS REPORTED DURING A PROCEDURE WHERE THE VERSACROSS RF WIRE, VERSACROSS TRANSSEPTAL SHEATH, NRG TRANSSEPTAL NEEDLE AND TORFLEX TRANSSEPTAL GUIDING SHEATH WERE USED. THE PATIENT HAD AN EXISTING PERICARDIAL EFFUSION THAT GREW DURING THE PROCEDURE DUE TO A SUSPECTED RIGHT ATRIUM PUNCTURE. THE PROCEDURE WAS ABORTED AND A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT STABILIZED AND WAS KEPT OVERNIGHT. THERE IS NO EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS A BAYLIS MEDICAL DEVICE WAS REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. SEPARATE PROBLEM REPORTS HAVE BEEN SUBMITTED FOR THE VERSACROSS TRANSSEPTAL SHEATH, VERSACROSS RF WIRE AND NRG TRANSSEPTAL NEEDLE.

  Patient problems: Pericardial Effusion

  MAUDE report 11278201 ↗
• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE NRG TRANSSEPTAL NEEDLE, PROTRACK PIGTAIL WIRE AND TORFLEX TRANSSEPTAL GUIDING SHEATH WERE USED IN A PROCEDURE. A PERICARDIAL EFFUSION OCCURRED AT THE END OF THE PROCEDURE. DURING TRANSSEPTAL PUNCTURE WHEN THE PHYSICIAN WAS TENTING THE SEPTUM, RADIOFREQUENCY ENERGY WAS APPLIED AND THE NRG TRANSSEPTAL NEEDLE INADVERTENTLY SLIPPED AND CROSSED THE SEPTUM. PREMATURE VENTRICULAR CONTRACTIONS WERE OBSERVED AND THE PHYSICIAN BROUGHT THE PROTRACK PIGTAIL WIRE IN THROUGH THE TORFLEX TRANSSEPTAL GUIDING SHEATH. THE PHYSICIAN HAD DIFFICULTY GETTING THE PROTRACK PIGTAIL WIRE TO CURL. ONCE BOTH CURLS HAD DEPLOYED ACROSS THE SEPTUM, THE PHYSICIAN BROUGHT THE TORFLEX TRANSSEPTAL GUIDING SHEATH UP. NO EFFUSION WAS NOTED AT THIS TIME. THE PROTRACK PIGTAIL WIRE WAS REMOVED AND THE CURL WAS VISUALLY OBSERVED TO STILL BE INTACT WITH NO ANOMALIES. AT THE END OF THE PROCEDURE, A LARGE EFFUSION WAS NOTED THAT RESULTED IN PERICARDIOCENTESIS WITH 400CC OF BLOOD REMOVED FROM THE HEART. THE CASE WAS NOTED TO BE CHALLENGING. 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 US

  Patient problems: Pericardial Effusion

  MAUDE report 8867691 ↗
• MalfunctionMay 8, 2019Device Damaged by Another Device; Device Damaged by Another Device

  THE TORFLEX TRANSSEPTAL GUIDING SHEATH WAS USED WITH A BIOSENSE WEBSTER ABLATION CATHETER DURING A SUCCESSFUL ABLATION PROCEDURE. AS THE PHYSICIAN REMOVED BOTH THE CATHETER AND THE SHEATH FOLLOWING THE PROCEDURE, A THIN TRANSLUCENT MATERIAL WAS OBSERVED AT THE TIP OF THE SHEATH. THERE IS NO EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS THE BAYLIS MEDICAL DEVICE WAS REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8593729 ↗
• InjuryMar 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE NRG TRANSSEPTAL NEEDLE (NRG NEEDLE) AND TORFLEX TRANSSEPTAL GUIDING SHEATH (TFK) WERE USED FOR TRANSSEPTAL PUNCTURE IN A PROCEDURE. THE PHYSICIAN NOTICED AN EFFUSION ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) FOLLOWING THE FIRST AND DURING THE SECOND TRANSSEPTAL PUNCTURE. THE PHYSICIAN USED AN AGILIS SHEATH AND 98 CM C1 NRG NEEDLE TO PERFORM THE FIRST TRANSSEPTAL PUNCTURE. THE PHYSICIAN WAS ABLE TO PUNCTURE ACROSS THE SEPTUM EASILY IN A SAFE POSITION IN THE MIDDLE OF THE SEPTUM VIA ICE. THE PHYSICIAN THEN PREPARED FOR THE SECOND TRANSSEPTAL USING THE 45 DEGREE TFK AND 71 CM C1 NRG NEEDLE. THE PHYSICIAN HAD SOME DIFFICULTY GETTING INTO THE CORRECT POSITION AND WAS IN A VERY POSTERIOR AND LOW POSITION WITH THE SHEATH AND DILATOR. THE NRG NEEDLE WAS NEVER EXPOSED IN THIS POSITION. THE PHYSICIAN THEN TORQUED THE SHEATH AND NEEDLE INTO A BETTER TENTING POSITION AND APPLIED RF ENERGY FOR 1 SECOND (CONSTANT). BEFORE PUTTING ANYTHING ACROSS THE SEPTUM OTHER THAN THE NRG NEEDLE, THE PHYSICIAN SCANNED ICE AND NOTICED A LARGE EFFUSION DEVELOPING. THE PHYSICIAN MONITORED THE EFFUSION FOR A FEW MINUTES AND DECIDED IN CONSULTATION WITH ANOTHER PHYSICIAN THAT A PERICARDIAL TAP WAS REQUIRED. ONCE

  Patient problems: Pericardial Effusion

  MAUDE report 8454007 ↗