VersaCross Access Solution VXSK0003Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00685447017066), received between Jun 5, 2025 and Jun 5, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (2 reports).

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.

• InjuryJun 5, 2025Display or Visual Feedback Problem; Positioning Problem; Display or Visual Feedback Problem; Positioning Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION (PE) AND CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A PULMONARY VEIN ISOLATION PULSE FIELD ABLATION PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA. A PRE-PROCEDURE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) CONFIRMED THERE WAS NO CLOT IN THE APPENDAGE AND THERE WAS NO MENTION OF A BASELINE EFFUSION. THE PHYSICIAN OBTAINED GROIN ACCESS AND INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WAS PLACED. THE ATRIUM WAS EXTREMELY DILATED AND THE PHYSICIAN STRUGGLED TO GET THE TIP OF THE SHEATH ON FOSSA. THE DILATOR WAS WITHDRAWN OUT OF THE BODY, MORE CURVE WAS ADDED AND PLACED IT BACK INTO THE BODY THROUGH THE SHEATH THAT WAS IN THE BODY. WITH THE EXTRA CURVE PLACED ON THE DILATOR, THE PHYSICIAN WAS ABLE TO GET THE SHEATH TO REACH THE FOSSA. ONCE DROPPED ONTO THE FOSSA, THE RADIO FREQUENCY (RF) WAS APPLIED FOR TRANSSEPTAL PUNCTURE (TSP). THE TSP APPEARED TO VERY SUPERIOR AND THERE WAS NO CLEAR TENTING ON ICE. A BUBBLE STUDY WAS PERFORMED AND THERE WERE BUBBLES IN THE LEFT ATRIUM (LA) AND IT WAS CONFIRMED THE VERSACROSS SHEATH IN THE LA. AN ARTERIOGRAM CONTRAST SHOT WAS PERFORMED. AT

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 22149117 ↗
• InjuryJun 5, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION (PE) AND CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A PULMONARY VEIN ISOLATION PULSE FIELD ABLATION PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA. A PRE-PROCEDURE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) CONFIRMED THERE WAS NO CLOT IN THE APPENDAGE AND THERE WAS NO MENTION OF A BASELINE EFFUSION. THE PHYSICIAN OBTAINED GROIN ACCESS AND INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WAS PLACED. THE ATRIUM WAS EXTREMELY DILATED AND THE PHYSICIAN STRUGGLED TO GET THE TIP OF THE SHEATH ON FOSSA. THE DILATOR WAS WITHDRAWN OUT OF THE BODY, MORE CURVE WAS ADDED AND PLACED IT BACK INTO THE BODY THROUGH THE SHEATH THAT WAS IN THE BODY. WITH THE EXTRA CURVE PLACED ON THE DILATOR, THE PHYSICIAN WAS ABLE TO GET THE SHEATH TO REACH THE FOSSA. ONCE DROPPED ONTO THE FOSSA, THE RADIO FREQUENCY (RF) WAS APPLIED FOR TRANSSEPTAL PUNCTURE (TSP). THE TSP APPEARED TO VERY SUPERIOR AND THERE WAS NO CLEAR TENTING ON ICE. A BUBBLE STUDY WAS PERFORMED AND THERE WERE BUBBLES IN THE LEFT ATRIUM (LA) AND IT WAS CONFIRMED THE VERSACROSS SHEATH IN THE LA. AN ARTERIOGRAM CONTRAST SHOT WAS PERFORMED. AT

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 22149041 ↗