TorFlex Transseptal Guiding SheathRecalls & reported problems across all models

We found 3 models of TorFlex Transseptal Guiding Sheath by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 16 adverse event reports in the FDA's MAUDE database, received between Sep 1, 2022 and Sep 29, 2026 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (11 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

TorFlex Transseptal Guiding Sheath recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 2 of these models · Recall details · FDA record ↗

Most reported TorFlex Transseptal Guiding Sheath problems

TorFlex Transseptal Guiding Sheath models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TorFlex Transseptal Guiding Sheath TF85-32-63-45

  Introducer, Catheter
  1 recall12 reports
• TorFlex Transseptal Guiding Sheath TF85-32-63-55

  Introducer, Catheter
  1 recall1 report
• TorFlex Transseptal Guiding Sheath TF85-32-63-90

  Introducer, Catheter
  3 reports

Recent TorFlex Transseptal Guiding Sheath adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT BMC TRANSSEPTAL SHEATH WAS SELECTED FOR USE. DURING THE PREPARATION IT WAS MENTIONED THAT THE STOPCOCK BROKE WHEN THE DEVICE WAS DROPPED ON THE TABLE. NO LEAK WAS NOTED NOR ANY DAMAGE WAS NOTED WHEN REMOVED FROM THE PACKAGE. THUS, THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24508285 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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