VersaCross Steerable Sheath VST85-35-BD-71S-D1Recalls & reported problems
Baylis Médicale Cie Inc · 1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire; 1 x VersaCross Transseptal Dilator · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00685447005780), received between Apr 1, 2022 and Mar 19, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Deformation1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2024Material Integrity Problem; Material Integrity Problem
IT HAS BEEN REPORTED THAT A VERSACROSS STEERABLE SHEATH WAS SELECTED FOR USE FOR AN ATRIAL FIBRILLATION (A FIB) ABLATION PROCEDURE. POST PROCEDURE, WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE DILATOR WAS NOTED TO BE DAMAGED. A PIECE OF PLASTIC OR PART OF THE INNER LUMEN CAME OUT OF THE DILATOR. PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS REPORTED. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS AS IT WAS DISPOSED OF AT THE FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18938346 ↗MalfunctionApr 1, 2022Material Deformation; Material Deformation
A 20- MINUTE PROCEDURAL DELAY WAS REPORTED DURING A PROCEDURE DUE TO THE KINKING OF THE VERSACROSS STEERABLE SHEATH WHILE TRYING TO INSERT THE CATHETER INTO THE PATIENT'S GROIN. THE PROCEDURE WAS ABLE TO CONTINUE AFTER A NEW VERSACROSS STEERABLE SHEATH WAS OPENED AND USED. WHILE THERE WAS NO PATIENT INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE RESULTING PROCEDURAL DELAY THAT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13982730 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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