VersaCross Connect LAAC Access Solution VXAK0009 (REF NA)Recalls & reported problems
Baylis Médicale Cie Inc · 1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical 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 00685447012603), received between May 24, 2024 and May 24, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Device-Device Incompatibility1
Patient problems
- Cardiac Perforation1
- Cardiac Tamponade1
- Pericardial Effusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 24, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT HAS BEEN REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE INDICATED FOR A CASE OF NONVALVULAR ATRIAL FIBRILLATION (NVAF). A PERFORATION, PERICARDIAL EFFUSION AND CARDIAC TAMPONADE OCCURRED; PROCEDURE CANCELLED. DURING THE PROCEDURE, THE PHYSICIAN MENTIONED THAT THE PATIENT HAD A LIPOMATOUS SEPTUM WITH LIMITED TRANSSEPTAL CROSSING OPTIONS. THE VERSACROSS DEVICES WERE USED FOR TRANSSEPTAL. THE LOCATION OF THE CROSSING WAS MID-MID AND THE WIRE/SHEATH CROSSED OVER INTO THE LEFT ATRIUM WITH NO COMPLICATIONS. SHORTLY AFTER, IT WAS NOTICED THAT THERE WAS AN INCREASING BUILDUP OF FLUID IN THE TRANSVERSE SINUS. THUS, IT WAS DECIDED TO VIEW THE PERICARDIUM WITH A ABBOTT VIEWFLEX ICE CATHETER, WHICH IS WHEN THEY SAW A LARGE EFFUSION AND TAMPONADE. PERICARDIOCENTESIS AND AN AUTOTRANSFUSION WERE PERFORMED, THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE, REQUIRING INTUBATION. THE PERICARDIOCENTESIS WAS SAID TO BE SUCCESSFUL, ALTHOUGH THE BLEEDING CONTINUED, AND THE EFFUSION DID NOT APPEAR TO BE DECREASING ON ICE. A CARDIOTHORACIC (CT) SURGERY WAS THEN REQUESTED WHERE A STERNOTOMY WAS PERFORMED, AND THE SOURCE OF THE BLEEDIN
Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion
MAUDE report 19393137 ↗
Other Dilator, Vessel, For Percutaneous Catheterization devices
- VersaCross Connect LAAC Access Solution VXAK0007Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization3 deaths108 reports
- TandemLife 5740-2417Cardiacassist, Inc. · Dilator, Vessel, For Percutaneous Catheterization2 recalls0 reports
- TightRail Rotating Dilator Sheath 545-513Spectranetics Corporation · Dilator, Vessel, For Percutaneous Catheterization20 deaths74 reports
- VersaCross Connect LAAC Access Solution VXAK0003Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization2 deaths70 reports
- VersaCross Connect LAAC Access Solution VXAK0007Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization2 deaths54 reports
- AVANTI 504656XCordis Corporation · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall2 reports
- Mini Stick MAX H965457490Angiodynamics, Inc. · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall1 report
- Mini Stick MAX H965457510Angiodynamics, Inc. · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.