VersaCross Connect Access Solution for POLARSHEATH VXAK0031Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00685447019008), received between Nov 6, 2023 and Aug 25, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) OCCURRED POST PROCEDURE. DURING A CRYOABLATION PROCEDURE, A VERSACROSS CONNECT FOR POLARSHEATH WAS SELECTED FOR USE. THE TRANSEPTAL WAS PERFORMED UNEVENTFUL AND WAS FULLY VISUALIZED UNDER INTRACARDIAC ECHOCARDIOGRAPHY (ICE). FOLLOWING THE SUCCESSFUL ISOLATION OF ALL 4 PULMONARY VEINS FOR ATRIAL FIBRILLATION WITH CRYO ABLATION THE PHYSICIAN WAS PERFORMING FINAL SWEEPS ON ICE TO CHECK THE PERICARDIUM AND THE PHYSICIAN NOTICED AN EFFUSION THAT WAS NOT APPARENT AT BASELINE. THE PHYSICIAN STARTED REVERSAL WITH PROTAMINE. THERE WERE NO CHANGES IN HEMODYNAMICS THROUGHOUT THE ENTIRE CASE THAT WOULD INDICATE AN THE PRESENCE OF AN EFFUSION. THE PHYSICIAN MONITORED THE EFFUSION FOR THE NEXT THIRTY MINUTES WITH ICE AND HAD A TRANSTHORACIC ECHOCARDIOGRAM (TTE) PERFORMED. THE EFFUSION WAS MOST NOTABLE AT THE BASAL ASPECT OF THE RIGHT VENTRICULAR (RV) AND MEASURE APPROXIMATELY 2.1 CENTIMETERS AT ITS LARGEST POINT. DURING MONITORING ULTRASOUND CONTRAST WAS ADMINISTERED INTRAVENOUSLY AND WAS ASSESSED TO SEE IF IT ENTERED THE PERICARDIAL SPACE. IT WAS CONFIRMED NO CONTRAST ENTERED THE PERICARDIAL SPACE. THE PATIENT'S HEMODYNAMICS WERE NOT ALTERED AT A

  Patient problems: Pericardial Effusion

  MAUDE report 22883882 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AIR EMBOLISM HAS OCCURRED. DURING A PROCEDURE, A VERSACROSS CONNECT FOR POLARSHEATH WAS SELECTED FOR USE. AN AIR EMBOLISM OCCURRED DURING AN ABLATION WITH A POLARSHEATH VERSACROSS CONNECT DEVICE. UPON REVIEW, THE DEVICE WAS BELIEVED TO BE A CONTRIBUTORY TO THE AIR LEAK. MEDWATCH REPORT# MW5153049

  Patient problems: Air Embolism

  MAUDE report 19176801 ↗
• MalfunctionFeb 6, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION WAS SELECTED FOR USE DURING AN ATRIAL FIBRILLATION ABLATION. THE VERSACROSS RF WIRE WAS REMOVED AFTER TRANSEPTAL PUNCTURE AND IT WAS NOTED THAT THE COATED HAD BEEN SCRAPPED OFF THE VERSACROSS RF WIRE BUT REMAINED CONNECTED, NO COATING WAS MISSING. NO PATIENT COMPLICATIONS WERE NOTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). THE PHYSICIAN DID NOT FEEL LIKE THE WIRE WAS GETTING CAUGHT WHILE RETRACTING, REQUIRING THEM TO PULL WITH EXCESSIVE FORCE. THE PATIENT DID NOT HAVE ANY MECHANICAL HARDWARE (LEADS, ETC) IN THEIR RA THAT THE WIRE GOT CAUGHT IN. THE INSULATION PEELING BACK AT THE DISTAL END JUST PROXIMAL, BUT IT WAS INTACT. NO OTHER ACCESSORY DEVICE WAS USED WITH THE VERSACROSS WIRE, ASIDE FROM THE VERSACROSS DILATOR. NO OTHER DAMAGE WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18656191 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION ABLATION (A FIB) PROCEDURE, A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE CASE PROCEEDED AS USUAL; A RADIOFREQUENCY (RF) ABLATION WAS USED TO TOUCH UP THE RIGHT SUPERIOR PULMONARY VEIN. AFTER ABOUT AN HOUR OF ABLATING, WHEN THE POLARX CRYOBALLOON AND POLARMAP WERE WITHDRAWN FROM THE LEFT ATRIUM TO THE RIGHT ATRIUM, THE PHYSICIAN NOTICED A PERICARDIAL EFFUSION DUE TO A PERFORATION VIA A NON-BOSTON SCIENTIFIC ICE CATHETER. THE EFFUSION WAS POSTERIOR TO LEFT VENTRICLE (LV) THE PATIENT WAS MONITORED FOR 20 MINUTES, AND EFFUSION DID NOT GROW. THE APPEARANCE OF THE PE WAS SIGNIFICANTLY LARGER AND MORE NOTICEABLE AFTER THE PROCEDURE. NO DIFFICULTIES OR COMPLICATIONS NOTED DURING THE PROCEDURE. THE PERFORATION WAS ONLY NOTICED AT THE VERY END OF THE CASE, BUT THE PHYSICIAN BELIEVES IT HAD ALREADY CLOSED OFF BECAUSE THE EFFUSION DID NOT GET ANY BIGGER AT THE END OF THE PROCEDURE. THE TRANSSEPTAL WAS COMPLETED PRIOR TO SIGNIFICANT PE AND RADIO FREQUENCY WAS ONLY APPLIED ONCE. NO REASON TO BELIEVE THAT THE VERSACROSS WIRE MALFUNCTIONED DURING THE PROCEDURE, AND NO OTHER ISSUES WERE NOTED. THE PATIENT DID NOT HAVE A PRIOR

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 18081376 ↗