TorFlex Transseptal Guiding Sheath TF85-32-63-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00685447005414), received between Jun 1, 2023 and Feb 26, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT A TORFLEX HAS ARRIVED DAMAGED. IT WAS REPORTED THAT THE PACKAGING AND PRODUCT ARRIVED AT THE FACILITY DAMAGED; THE TORFLEX PACKAGING LOOKED AS IF IT HAD BEEN FOLDED AND HAD MULTIPLE CREASES DOWN THE SLEEVE; STERILE PACKAGING WAS NOT COMPROMISED. NO PATIENT INVOLVEMENT WAS REPORTED. IT WAS FURTHER EVALUATED DURING ANALYSIS (12FEB2024) THAT BASED ON PHOTOS PROVIDED, THAT THE PACKAGING IS DAMAGED, AND INTEGRITY OF DEVICES IS IN DOUBT. A VISUAL INSPECTION WAS CONDUCTED BASED ON THE PHOTOS SUBMITTED, AND IT WAS NOTED THAT THE RE-PACK SHIPPER IDENTIFIED DAMAGED AT ONE END AS WELL AS MULTIPLE CREASES IDENTIFIED OVERALL. ALSO, A DAMAGE HAS BEEN IDENTIFIED IN THE CATON, THE INTEGRITY OF THE DEVICE AND STERILE BARRIER SYSTEM IS IN DOUBT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18785547 ↗
• MalfunctionSep 27, 2023Break; Break

  IT WAS REPORTED THAT A BMC TRANSSEPTAL SHEATH WAS SELECTED FOR USE. DURING PREPARATION OF THE PROCEDURE, THE DEVICE WAS OPENED ON STERILE TABLE AND WHEN THE 3-WAY VALVE WAS ADJUSTED, THE HANDLE CAME APART. THE STOPCOCK WAS BEING HANDLED FOR THE FIRST TIME AS IT BROKE OFF AND THERE WAS NO RESISTANCE WITH THE ARM ROTATION. IT WAS THE VALVE ITSELF THAT BROKE OFF, NOT THE LEVER. A FLUSHING WAS PERFORMED BEFORE USE OF THE DEVICE, WITH NO ISSUE WITH IT. NO OTHER ISSUES WERE NOTED. THUS, A NEW INTRODUCER SHEATH WAS SELECTED FOR USE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17826731 ↗
• MalfunctionJun 1, 2023Break; Break

  IT WAS REPORTED THAT A TORFLEX - BMC TRANSSEPTAL SHEATH WAS DEFECTIVE. WHILE PREPARING FOR AN ATRIUM FIBRILLATION ABLATION PROCEDURE, ONCE STAFF OPENED PRODUCT ON STERILE TABLE, IT WAS NOTED THAT THE SHEATH SIDE PORT WAS BROKEN, THE ISSUE WAS NOTED BEFORE THE DEVICE WAS USED IN THE PATIENT. A REPLACEMENT SHEATH WAS PULLED TO PERFORM PROCEDURE. NO OTHER ISSUES WERE NOTED WITH THE PREPARATION OF THE DEVICE. A REPLACEMENT SHEATH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17039602 ↗