SureFlex Steerable Guiding Sheath TSK85-32-BD-71S (REF NA)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00685447006305), received between Jul 18, 2023 and Oct 23, 2024 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionOct 23, 2024Defective Device; Defective Device

  IT WAS REPORTED DURING A PROCEDURE, A SUREFLEX STEERABLE GUIDING SHEATH WAS SELECTED FOR USE. THE DILATOR WAS FOUND TO HAVE A SMALL PIECE HANGING AT THE DISTAL TIP. THE DEFECT WAS FOUND WHEN THE SHEATH WAS BEING FLUSHED. HENCE THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515333 ↗
• MalfunctionJul 18, 2023Defective Device; Material Integrity Problem; Defective Device; Material Integrity Problem

  IT WAS REPORTED THAT A BMC STEERABLE SHEATH - SUREFLEX WAS SELECTED FOR USE DURING A PULMONARY VEIN ISOLATION FOR ATRIAL FIBRILLATION. DURING ISOLATION OF THE RIGHT PULMONARY VEIN, IT WAS FOUND THAT THE SIDE PORT WAS SEPARATED/DETACHED FROM THE HUB HANDLE (SEPARATED IN TWO PIECES). THERE WAS NO SIGN OF TORSION, AND THE ADHESIVE PART HAD COME LOOSE. THUS, A SECOND DEVICE OF THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. NO OTHER ISSUE WAS NOTED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17347067 ↗
• InjuryJul 18, 2023Difficult to Insert; Defective Device; Difficult to Insert; Defective Device

  IT WAS REPORTED THAT DURING A PERCUTANEOUS CATHETER MYOCARDIAL ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB) IN RIGHT INGUINAL AREA, A SUREFLEX STEERABLE GUIDING SHEATH WAS SELECTED FOR USE. WHEN THE SUREFLEX WAS TRIED TO BE INSERTED, THE TIP OF THE SHEATH GOT LIFTED AND THE BLEEDING CONTINUED FROM THE SIDE OF THE SHEATH. THIS OCCURRED JUST BELOW THE RIGHT INGUINAL REGION. IT WAS NOT ADVANCED DEEP IN THE ANATOMY. THERE WAS SLIGHT DIFFICULTY REMOVING THE SHEATH. THE BLEEDING WAS STOPPED WITH A NON-BOSTON SCIENTIFIC DEVICE. A NEW SUREFLEX WAS USED TO PERFORM A NEW PUNCTURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17344138 ↗