VersaCross Access Solution VXSK0033 (REF NA)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00685447011842), received between May 4, 2023 and May 4, 2023 — classified as 2 injuries.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE IN THE LEFT ATRIAL APPENDAGE (LAA) TO TREAT ATRIAL FIBRILLATION (AFIB), A VERSACROSS SHEATH AND RF WIRE WERE SELECTED FOR USE. POST RIGHT GROIN VENOUS ACCESS THE SHEATH AND THE WIRE WERE ADVANCED TO THE SUPERIOR VENA CAVA (SVC). THE PHYSICIAN APPROACHED THE SYSTEM TO THE SEPTUM, BUT IT WOULD GO TO THE INFERIOR VENA CAVA (IVC). SEVERAL ATTEMPTS WERE PERFORMED, AND THE PATIENT EXPERIENCED COMPLETE HEART BLOCK. MEDICATION, CARDIOPULMONARY RESUSCITATION (CPR) AND HEART PACING ALSO HELPED THE PATIENT TO BECOME HEMODYNAMICALLY STABLE. ONCE THE PATIENT BECAME STABLE A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A LARGE EFFUSION AND CARDIAC TAMPONADE WHILE THE SYSTEM WAS IN THE RIGHT ATRIUM (RA). THE PROCEDURE WAS CANCELLED AND PERICARDIOCENTESIS WAS PERFORMED; 300 ML OF FLUID WERE DRAINED FROM THE PERICARDIUM. THE EFFUSION BECAME SMALLER AND THE PATIENT WAS HEMODYNAMICALLY STABLE TO GO TO INTENSIVE CARE UNIT (ICU). IT IS EXPECTED THAT THE PATIENT WILL FULLY RECOVER.

  Patient problems: Cardiac Tamponade; Heart Block; Pericardial Effusion

  MAUDE report 16872642 ↗
• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE IN THE LEFT ATRIAL APPENDAGE (LAA) TO TREAT ATRIAL FIBRILLATION (AFIB), A VERSACROSS SHEATH AND RF WIRE WERE SELECTED FOR USE. POST RIGHT GROIN VENOUS ACCESS THE SHEATH AND THE WIRE WERE ADVANCED TO THE SUPERIOR VENA CAVA (SVC). THE PHYSICIAN APPROACHED THE SYSTEM TO THE SEPTUM, BUT IT WOULD GO TO THE INFERIOR VENA CAVA (IVC). SEVERAL ATTEMPTS WERE PERFORMED, AND THE PATIENT EXPERIENCED COMPLETE HEART BLOCK. MEDICATION, CARDIOPULMONARY RESUSCITATION (CPR) AND HEART PACING ALSO HELPED THE PATIENT TO BECOME HEMODYNAMICALLY STABLE. ONCE THE PATIENT BECAME STABLE A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A LARGE EFFUSION AND CARDIAC TAMPONADE WHILE THE SYSTEM WAS IN THE RIGHT ATRIUM (RA). THE PROCEDURE WAS CANCELLED AND PERICARDIOCENTESIS WAS PERFORMED; 300 ML OF FLUID WERE DRAINED FROM THE PERICARDIUM. THE EFFUSION BECAME SMALLER AND THE PATIENT WAS HEMODYNAMICALLY STABLE TO GO TO INTENSIVE CARE UNIT (ICU). IT IS EXPECTED THAT THE PATIENT WILL FULLY RECOVER.

  Patient problems: Cardiac Tamponade; Heart Block; Pericardial Effusion

  MAUDE report 16870552 ↗