SureFlex Steerable Guiding Sheath TSK0005 (REF NA)Recalls & reported problems
Baylis Médicale Cie Inc · SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00685447005650), received between Jan 9, 2025 and Jan 9, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A SUREFLEX STEERABLE GUIDING SHEATH WAS SELECTED FOR USE DURING AN ABLATION PROCEDURE. DURING THE PROCEDURE, APPEARANCE OF AIR HAS OCCURRED, WHILE INSERTING THE NON-BOSTON SCIENTIFIC CATHETER (BEEAT). THE AIR WAS OBSERVED TO BE IN THE SYRINGE. NO AIR WAS OBSERVED WITHIN THE SHEATH WHEN THE DILATOR WAS REMOVED FROM IT. THE SUCTION WAS CONFIRMED. WHEN THE SHEATH AND CATHETER WERE INSERTED, SUCTION WAS PERFORMED FROM THE SIDE PORT, THE AIR WAS ABLE TO BE REMOVED, SO A REPLACEMENT OF THE SHEATH WAS PERFORMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21118435 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.