SureFlex Steerable Guiding Sheath TSK0004 (REF NA)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00685447005643), received between Jan 14, 2025 and Jun 2, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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. How this data works · Data updated Oct 13, 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 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SUREFLEX STEERABLE SHEATH WAS SELECTED FOR PERCUTANEOUS CATHETER MYOCARDIAL ABLATION. DURING THE PROCEDURE, BLOOD LEAKAGE WAS NOTED FROM THE HEMOSTATIC VALVE OF THE SHEATH. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISCARDED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125430 ↗
• MalfunctionJan 14, 2025Mechanical Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A PULMONARY VEIN ISOLATION PROCEDURE, A SUREFLEX STEERABLE GUIDING SHEATH WAS SELECTED FOR USE. THE ABLATION CATHETER WAS NOT DISPLAYED ON THE 3-D DISPLAY. AN ATTEMPT WAS MADE TO REPLACE THE CATHETER BY REMOVING IT FROM THE SHEATH. ASPIRATION WAS PERFORMED FROM THE THREE-WAY LIVE WIRE OF THE SHEATH, AND WHEN IT WAS RELEASED, AIR WAS DRAWN IN FROM THE PORT TOWARD THE TIP OF THE SHEATH. UPON NOTICING THE ABNORMALITY, THE THREE-WAY LIVE WIRE WAS IMMEDIATELY TURNED OFF, AND THE DRAWN-IN AIR WAS ASPIRATED WITH A SYRINGE. THE SHEATH WAS THEN REMOVED FROM THE BODY. AN ECHO SHOWED NO PROBLEMS WITH CARDIAC FUNCTION, AND NO CHANGES WERE CONFIRMED IN THE ELECTROCARDIOGRAM. IN THE PHYSICIAN OPINION, THE SHAFT OF THE SHEATH GOT KINKED CAUSING NEGATIVE PRESSURE INSIDE THE SHEATH WHEN THE ABLATION CATHETER WAS REMOVED, WHICH COULD HAVE CAUSED AIR TO BE DRAWN IN WHEN THE THREE-WAY WIRE WAS RELEASED. LATER, THE PROCEDURE WAS CANCELLED DUE TO ANOTHER REASON. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. THE PROCEDURE WAS NOT CANCELLED DUE TO DEVICE, AS THIS WAS A CASE OF ATRIAL FIBRILLATION REDO AND PULMONARY VEIN ISOLATION HAD BEEN ACHIEVED, THE PROCEDURE WAS DISCONTINU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148325 ↗