SureFlex Steerable Guiding Sheath TSK0005 (REF NA)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00685447006220), received between Apr 14, 2023 and Feb 20, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2024Leak/Splash; Defective Device; Leak/Splash; Defective Device

  IT WAS REPORTED THAT A BMC STEERABLE SHEATH (SUREFLEX) AND NRG RF NEEDLE WERE SELECTED FOR USE DURING AN ABLATION PROCEDURE. THE TIP OF THE NRG RF NEEDLE BROKE WHEN USING THE RF NEEDLE. IT PASSED THROUGH THE FORAMEN OVALE WITHOUT ENERGIZING, SO IT WAS COMPLETED WITHOUT ENERGIZING. ADDITIONALLY, WHEN USING SUREFLEX DURING PRE-MAPPING, THE HEMOSTATIC VALVE SEEMED TO FAIL OR BLOOD BEGAN TO LEAK, THUS THE DEVICE WAS REPLACED. NO PATIENT COMPLICATION WAS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICES ARE NOT EXPECTED TO BE RETURNED FOR ANALYSIS. IT WAS FURTHER INFORMED THAT THE NRG NEEDLE WAS ABLE TO CROSS THE FORAMEN OVALE WITHOUT PERFORMING ENERGIZATION (RADIO FREQUENCY WAS NOT DELIVERED). NO ALERT OR ERROR WAS REPORTED. SINCE THE PROCEDURE WAS ABLE TO BE COMPLETED WITHOUT ENERGIZATION, RF WAS NOT DELIVERED. ADDITIONALLY, THE LEAK WAS IDENTIFIED WHEN USING SUREFLEX DURING PRE-MAPPING, BLOOD BEGAN TO LEAK FROM HEMOSTASTIC VALVE (SLOW DRIP). IT APPEARS THAT THE LEAK WAS COMING FROM THE HEMOSTATIC VALVE. NO FLUID WAS LEAKING FROM THE DISTAL OR PROXIMAL END OF THE HANDLE. BLOOD WAS NOTED LEAKING, WHICH STOPPED USING THE DEVICE (SUREFLEX). NO LEAK AIR WAS REPORTED. NO AIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743723 ↗
• MalfunctionAug 17, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A BMC STEERABLE SHEATH WAS SELECTED FOR USE DURING AN ATRIAL FIBRILLATION (A FIB). DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS BACK FLOW FROM THE HEMOSTATIC VALVE (IT IS SAID THAT BLOOD LEAKED (A FEW DROPS DRIPPING) FROM THE INSERTION SITE DURING REVERSE BLOOD FLOW), THUS ANOTHER OF THE SAME DEVICE WAS USED AND PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISCARDED). NO OTHER ISSUES WERE REPORTED. THE DILATOR WAS WIPED OUT PRIOR TO INTRODUCTION INTO THE VALVE, IT'S PROBABLY MOISTENED BECAUSE IT WAS FLASHED DURING SETUP. NO CLINICAL EVENT OCCURRED DUE TO BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17564825 ↗
• MalfunctionMay 3, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PROCEDURE A SUREFLEX STEERABLE GUIDING SHEATH WAS SELECTED FOR USE. THE JOINT BETWEEN THE SHEATH AND DILATOR PEELED OFF DURING A PUNCTURE ATTEMPT AND PUNCTURE WAS NOT POSSIBLE. THE SHEATH WAS REPLACED WITH ANOTHER OF THE SAME MODEL AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860138 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE ATRIAL SEPTAL PUNCTURE A NRG TRANSSEPTAL NEEDLE AND SUREFLEX STEERABLE GUIDING SHEATH WERE SELECTED FOR USE. IT WAS REPORTED THAT THE ROOF PART OF THE RIGHT ATRIUM WAS DAMAGED, RESULTING IN CARDIAC TAMPONADE. PERICARDIOCENTESIS WAS PERFORMED UNDER ECHO GUIDE, HOWEVER, THE BLEEDING DID NOT STOP. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. IT WAS SUSPECTED THAT THE DAMAGE NOTED IN THE RIGHT ATRIUM WAS DUE TO THE RADIOFREQUENCY TRANSSEPTAL NEEDLE, BUT IT WAS NOT CONFIRMED. WHEN ROUTINE LEFT ATRIAL ANGIOGRAPHY WAS PERFORMED, IT WAS FOUND OUT THAT CARDIAC TAMPONADE OCCURRED DUE TO CONTRAST MEDIA ACCUMULATING IN THE PERICARDIUM AND NOT IN THE LEFT ATRIUM.

  Patient problems: Cardiac Perforation; Cardiac Tamponade

  MAUDE report 16743277 ↗