TorFlex Transseptal Guiding Sheath TF85-32-63-45 (UDI 00685447005391)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00685447005391), received between Sep 1, 2022 and Sep 29, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 10, 2025Class IIOpen, Classified

   Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.

   Z-2106-2025 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50940943 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED THAT DURING THE WATCHMAN PROCEDURE TO TREAT ATRIAL FIBRILLATION TORFLEX TRANSSEPTAL GUIDING SHEATH WAS SELECTED FOR USE. UPON THE DEVICE PREPPING THE STOPCOCK BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A DIFFERENT DEVICE (SAME MODEL, BOSTON SCIENTIFIC PRODUCT). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED. THE PRODUCT IS EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454982 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT TORFLEX TRANSSEPTAL GUIDING SHEATH WAS SELECTED FOR ABLATION. IT WAS MENTIONED THAT DURING THE PREPARATION WHEN THE DEVICE WAS OPENED, THE HUB WAS NOTED TO BE BROKEN IN AN AREA THAT COULD ENTER THE PATIENT. THUS THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS EXPECTED TO BE RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23982157 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT TORFLEX TRANSSEPTAL GUIDING SHEATH WAS SELECTED FOR ABLATION. IT WAS MENTIONED THAT DURING THE PREPARATION WHEN THE DEVICE WAS OPENED, THE HUB WAS NOTED TO BE BROKEN IN AN AREA THAT COULD ENTER THE PATIENT. THUS, THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS EXPECTED TO BE RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23982150 ↗
• MalfunctionJan 5, 2026Break; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE TORFLEX TRANSSEPTAL GUIDING SHEATH WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT DURING PROCEDURE THE PHYSICIAN NOTICED THE STOPCOCK WAS BROKEN AND LEAKING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED. THE PRODUCT IS EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959467 ↗
• MalfunctionDec 29, 2025Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT BMC TRANSSEPTAL SHEATH WAS SELECTED FOR USE. DURING PREPARATION WHEN THE DEVICE WAS UNPACKED THE STOPCOCK ASSEMBLY WAS NOTED TO BE BROKEN. THUS, THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS EXPECTED TO BE RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907825 ↗
• MalfunctionOct 29, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED DURING A FARAPULSE PULMONARY VEIN ISOLATION, A TORFLEX TRANSSEPTAL GUIDING SHEATH WAS SELECTED FOR USE. WHEN THE STAFF MEMBER OPENED THE DEVICE PACKAGING, IT WAS NOTED THE FRONT OF THE PACKAGING TORE ABNORMALLY. THE STAFF QUESTIONED THE INTEGRITY OF THE STERILITY OF THE PRODUCT AND DECIDED TO OPEN A REPLACEMENT KIT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558552 ↗
• MalfunctionOct 11, 2024Break; Break

  IT WAS REPORTED DURING ABLATION PROCEDURE INDICATED FOR AN ATRIAL FIBRILLATION (A FIB) CASE, A TORFLEX TRANSSEPTAL GUIDING SHEATH WAS SELECTED FOR USE. IT WAS NOTED THAT THE STOPCOCK ON THE SHEATH WAS FAULTY OR CAME OFF COMPLETELY DURING PREPARATION. HENCE, THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20428286 ↗
• MalfunctionOct 20, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT DURING THE PREPARATION OF THE TRANSEPTAL PUNCTURE PROCEDURE TO TREAT ATRIAL FIBRILLATION, TORFLEX TRANSSEPTAL GUIDING SHEATH WAS SELECTED FOR USE. THE BROKEN DEVICE WAS NOTED UPON OPENING THE PACKAGE. NO TROUBLESHOOTING STEPS HAVE BEEN MENTIONED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER TORFLEX TRANSSEPTAL GUIDING SHEATH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED. THE PRODUCT IS EXPECTED TO BE RETURNED. NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981299 ↗
• MalfunctionSep 27, 2023Break; Break

  IT WAS REPORTED THAT DURING THE PREPARATION OF AN ABLATION PROCEDURE TO TREAT TACHYCARDIA, A TORFLEX TRANSSEPTAL GUIDING SHEATH WAS SELECTED FOR USE. THE SHEATH WAS OPENED ON STERILE TABLE AND ONCE THE VALVE WAS ADJUSTED, THE HANDLE BROKE OFF. THE STOPCOCK WAS BEING HANDLED FOR THE FIRST TIME WHEN IT BROKE OFF. THERE WAS NO RESISTANCE EXPERIENCED WITH THE ARM ROTATION AND THE VALVE ITSELF BROKE OFF. HENCE TO RESOLVE THE ISSUE, A NEW SHEATH WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17827751 ↗
• MalfunctionJul 13, 2023Break; Break

  IT WAS REPORTED THAT DURING A PULMONARY VEIN ISOLATION PROCEDURE, A TORFLEX SHEATH WAS SELECTED WHICH HAD A BROKEN STOPCOCK. THE STOPCOCK WAS BROKEN WHEN OPENED THE PACKAGE. HENCE A NEW SHEATH WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316214 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CASE OF HEART BLOCK REQUIRING INTERVENTION DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS REPORTED WHERE THE BAYLIS MEDICAL NRG TRANSSEPTAL KIT WAS USED FOR TRANSSEPTAL PUNCTURE. AS REPORTED, THE RIGHT BUNDLE WAS INADVERTENTLY KNOCKED WHILE MANEUVERING THE TRANSSEPTAL SYSTEM, CAUSING THE PATIENT TO GO INTO HEART BLOCK. CARDIOPULMONARY RESUSCITATION AND EXTERNAL PACING WERE PERFORMED. THE PATIENT WAS STABILIZED AND THE LAAC PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS NO REASONABLE EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICES 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. A SEPARATE PROBLEM REPORT HAS BEEN SUBMITTED FOR THE NRG TRANSSEPTAL NEEDLE WITH THE REPORT NUMBER 3019751610-2022-00033.

  Patient problems: Heart Block

  MAUDE report 15341239 ↗