TorFlex Transseptal Guiding Sheath TF85-32-63-55 (UDI 00685447000709)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00685447000709), received between Nov 14, 2024 and Jun 23, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION PROCEDURE, A TORFLEX TRANSSEPTAL GUIDING SHEATH WAS SELECTED FOR USE. IT WAS NOTED THAT THERE WAS A STICKY PAPER ON OUTSIDE OF SHEATH. THE PROCEDURE SUCCESSFULLY COMPLETED USING ORIGINAL METHOD AND/OR DEVICE. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309678 ↗
• InjuryNov 14, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PATIENT BECAME HYPOTENSIVE AND EXPERIENCED A PERICARDIAL EFFUSION, LEADING TO CANCELLATION OF THE PROCEDURE. DURING A PULMONARY VEIN ISOLATION CRYOABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION, A NRG TRANSSEPTAL NEEDLE AND TORFLEX GUIDING SHEATH WERE SELECTED FOR USE. WHILE GAINING ACCESS AND CONSCIOUS SEDATION (LOCAL ANESTHESIA), THE PATIENT'S BLOOD PRESSURE DROPPED, WITH A SYSTOLIC READING OF 80MMHG. THE PROCEDURE WAS CONTINUED. UPON THE INTRODUCTION OF ICE INTO THE HEART, THE PHYSICIAN PERFORMED A BASELINE ASSESSMENT OF THE PERICARDIUM AND NOTED NO EFFUSIONS AT BASELINE. A CORONARY SINUS CATHETER AS WELL AS THIS POLARX WERE INTRODUCED. AN ELECTROPHYSIOLOGY STUDY WAS PERFORMED PRIOR TO TRANSEPTAL AND WAS NON RESULTANT. TRANSEPTAL WAS COMPLETED UNDER INTRACARDIAC ECHO WITH NRG NEEDLE AND TORFLEX SHEATH. THE PHYSICIAN SUCCESSFULLY CROSSED, AND HEPARIN WAS ADMINISTERED. THE LEFT SUPERIOR PULMONARY VEIN WAS WIRED, AND THE SHEATH WAS EXCHANGED FOR THE POLAR SHEATH. WHEN INTRODUCING THE POLAR SHEATH, PRESSURE WAS NEEDED, AND IT DID 'JUMP' WHEN CROSSING THE FOSSA OVALIS. THE POLARXFIT BALLOON WAS PREPPED AND INSERTED INTO THE LEFT ATRIUM. DURING MANIPULATION O

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 20683995 ↗