VersaCross Access Solution VXSK0011 (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)) · 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 00685447011620), received between Aug 15, 2024 and Aug 15, 2024 — 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.
MalfunctionAug 15, 2024Failure to Advance; Failure to Advance
IT HAS BEEN REPORTED THAT A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE. DURING THE PROCEDURE, THE TRANSSEPTAL PUNCTURE WAS NOT SUCCESSFUL USING RF APPLICATION. THE DEVICE WAS REPLACED (DIFFERENT DEVICE, SAME MODEL), AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE 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 19991046 ↗
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.