VersaCross Connect LAAC Access Solution VXAK0009 (REF NA)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00685447010548), received between Jan 27, 2026 and Jan 27, 2026 — 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2026Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT A CARDIAC PERFORATION, PERICARDIAL EFFUSION (PE) AND CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. THE PATIENT HAD PACEMAKER LEADS AND DUE TO THAT THE FELLOW PHYSICIAN WAS HAVING A HARD TIME NAVIGATING TO THE SUPERIOR VENA CAVA (SVC) WITH VERSACROSS RF WIRE. DURING SEVERAL ATTEMPTS TO CANNULATE THE SVC, AN EFFUSION IN RIGHT ATRIAL WAS NOTED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THUS, A PERICARDIOCENTESIS WAS PERFORMED, AND THE DECISION WAS MADE TO TAKE THE PATIENT FOR SURGICAL REPAIR WHEN EFFUSION DID NOT RESOLVE AFTER. THE PLAN WAS TO HAVE THEM CLIP THE APPENDAGE IN SURGERY. THE PATIENT WAS STABLE UP UNTIL THEY WERE TRANSPORTED TO SURGERY AND THEY WERE HOSPITALIZED BEYOND STANDARD OF CARE. THE PATIENT IS EXPECTED TO FULLY RECOVERY. THE PERFORATION WAS LOCATED AT THE RIGHT ATRIAL (RA), PRIOR TO TRANSSEPTAL ATTEMPT. THE LEFT SIDE WAS NEVER ACCESSED. THE PATIENT WAS NOT UNDER WARFARIN AT THE TIME, AND THEY WERE UNDER ELIQUIS DURING THE PROCEDURE. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 24193451 ↗