VersaCross Steerable Access Solution VSTK0022Recalls & reported problems
Baylis Médicale Cie Inc · 1 x VersaCross Steerable Sheath (including 1 x Dilator and 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00685447012139), received between Feb 7, 2024 and Feb 7, 2024 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cardiac Perforation1
- Cardiac Tamponade1
- Low Blood Pressure/ Hypotension1
- Pericardial Effusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A VERSCROSS RF WIRE WAS SELECTED FOR USE. A PERICARDIAL EFFUSION AND CARDIAC TAMPONADE WERE REPORTED. THE PROCEDURE WAS CANCELLED. DURING A PULSE FIELD ABLATION (PFA) PROCEDURE TO TREAT PERSISTENT ATRIAL FIBRILLATION, A VERSACROSS RF WIRE WAS SELECTED FOR USE ALONG WITH A FARADRIVE STEERABLE SHEATH CLEAR WERE SELECTED FOR USE. AIR INGRESS OCCURRED DURING ASPIRATION THAT COULD NOT BE CLEARED, AND A HEMOSTATIC VALVE LEAK WAS SUSPECTED. THE SHEATH WAS REPLACED WITH ANOTHER OF THE SAME MODEL, BUT DURING THE EXCHANGE A PERICARDIAL EFFUSION OCCURRED. THIS OCCURRED ABOUT 30 MINUTES POST CAVOTRICUSPID ISTHMUS (CTI) ABLATION. THE PERICARDIAL EFFUSION WAS TREATED VIA PERICARDIOCENTESIS. THE PROCEDURE COULD NOT BE COMPLETED DUE TO THE COMPLICATION AND WAS CANCELLED. THE PATIENT IS EXPECTED TO RECOVER FULLY. THE DEVICE (FARADRIVE) IS EXPECTED TO BE RETURNED FOR ANALYSIS. IT WAS FURTHER NOTED ON 08JAN2024 THAT THE PERICARDIAL PUNCTURE HAPPENED DURING THE TRANSEPTAL PUNCTURE OF THE SEVERELY ANEURYSMAL SEPTUM AND WAS NOTICED TO HAVE PROGRESSED TO TAMPONADE DURING FARADRIVE SHEATH INSERTION WHILE IT WAS STILL WITHIN THE RIGHT ATRIUM (RA). A VERSACROSS WIRE WAS USED AND WAS IN
Patient problems: Cardiac Perforation; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion
MAUDE report 18664374 ↗
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.