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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00685447006312), received between Mar 29, 2023 and Dec 14, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Flushing Problem” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2023Flushing Problem; Flushing Problem

  IT WAS REPORTED THE PATIENT STROKES OCCURRED. DURING AN ABLATION PROCEDURE, A SUREFLEX STEERABLE GUIDING SHEATH WAS SELECTED FOR USE. THE SHEATH WAS PREPARED AND THEN INTRODUCED INTO THE LEFT ATRIUM. THE SHEATH WAS ASPIRATED TO PREVENT BUBBLES. ONCE THE DEVICE WERE CONNECTED WITH A NON-BOSTON SCIENTIFIC MAPPING CATHETER AND ABLATING DEVICE, ABLATION WAS PERFORMED AND THE CATHETER WAS PULLED OUT FROM THE SHEATH. AT THIS POINT WHEN THE PHYSICIAN TRIED TO ASPIRATE, A RESISTANCE WAS FELT. THE PHYSICIAN IMMEDIATELY STOPPED THE PROCEDURE AND PULLED THE SHEATH OUT. OUTSIDE THE PATIENT BODY, THE SHEATH WAS FLUSHED BUT THERE WAS NO BLOOD COAGULUM. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. THE SHEATH WAS FLUSHED/ASPIRATED WITHOUT ANYTHING IN IT, IT WAS AFTER GETTING THE ABLATION CATHETER OUT OF THE SHEATH IT COULDN'T BE ASPIRATED. NO DAMAGES OR ISSUES NOTED WITH THE STOPCOCK. AFTER GETTING THE SHEATH OUT THERE WERE NOTHING ON THE TIP. THE "LITTLE STROKES" WERE SLOWLY TRANSIENT AND THE PATIENT SEEM TO BE RECOVER.

  Patient problems: Transient Ischemic Attack

  MAUDE report 18325795 ↗
• MalfunctionMar 29, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION (AFIB), A SUREFLEX STEERABLE SHEATH WAS SELECTED FOR USE. DURING THE PROCEDURE A LEAK WAS NOTED IN THE SHEATH. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS. THE PRODUCT WILL BE RETURNED FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16636685 ↗