SureFlex Steerable Guiding Sheath TSK85-32-BD-71S (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 00685447005797), received between Mar 7, 2025 and Mar 7, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper Flow or Infusion” (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
- Improper Flow or Infusion1
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.
MalfunctionMar 7, 2025Improper Flow or Infusion; Improper Flow or Infusion
IT HAS BEEN REPORTED THAT A SUREFLEX STEERABLE GUIDING SHEATH WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN MENTIONED THAT THEY WERE UNABLE TO ASPIRATE FLUID THROUGH THE DEVICE AFTER 1 HOUR OF USE INSIDE THE PATIENT. THE SHEATH WAS THEN REMOVED AND REPLACED; PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS (DISPOSED). IT HAS BEEN FURTHER MENTIONED THAT NO OTHER DEVICES WHERE INSIDE THE SHEATH WHEN THE ISSUE WAS NOTED. NO DAMAGE WAS NOTED ON THE DEVICE WHEN IT WAS REMOVED. HOWEVER, A PIECE OF TISSUE WAS FOUND ON THE TIP OF THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21548843 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.