VersaCross Access Solution VXSK0024 (REF NA)Recalls & reported problems
Baylis Médicale Cie Inc · 1 x VersaCross Transseptal Sheath (including 1 x J-tip Guidewire); 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use)); 1 x Dispersive Electrode · 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 00685447007456), received between May 13, 2025 and May 13, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance1
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.
MalfunctionMay 13, 2025Failure to Advance; Failure to Advance
IT WAS REPORTED THAT VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. IT WAS MENTIONED THAT WHEN SHEATH AND WIRE INTO THE BODY AND WHEN ATTEMPT WAS MADE FOR TRANSSEPTAL, THE WIRE DID NOT CROSS. UNKNOWN TROUBLESHOOTING WERE MADE. FINALLY, THE WIRE WAS REPLACED AND WAS ABLE TO CROSS. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22012265 ↗
Other Catheter, Septostomy devices
- VersaCross Access Solution VXSK0031Baylis Médicale Cie Inc · Catheter, Septostomy1 recall16 reports
- VersaCross Access Solution VXSK0021Baylis Médicale Cie Inc · Catheter, Septostomy1 recall1 death15 reports
- VersaCross Access Solution VXSK0032Baylis Médicale Cie Inc · Catheter, Septostomy1 recall14 reports
- VersaCross Access Solution VXSK0022Baylis Médicale Cie Inc · Catheter, Septostomy1 recall13 reports
- VersaCross Access Solution VXSK0024Baylis Médicale Cie Inc · Catheter, Septostomy1 recall3 reports
- VersaCross Access Solution VXSK0034Baylis Médicale Cie Inc · Catheter, Septostomy1 recall1 report
- VersaCross Access Solution VXSK0025Baylis Médicale Cie Inc · Catheter, Septostomy1 recall1 report
- NRG Transseptal Needle NRG-E-HF-71-C0Boston Scientific Corporation · Catheter, Septostomy22 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.