VersaCross Access Solution VXSK0033 (UDI 00685447017363)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00685447017363), received between Jun 9, 2025 and Jun 9, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Positioning 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. 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 9, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION (PE) WAS NOTED. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. THERE WAS A TRACE EFFUSION NOTED BEFORE THE PROCEDURE STARTED AND IT WAS LOCATED AT THE APEX OF THE HEART. THE VERSACROSS WIRE WAS INSERTED IN THE SUPERIOR VENA CAVA (SVC), WITH THE SHEATH TO FOLLOW. THE PHYSICIAN BROUGHT THE WHOLE SYSTEM DOWN ONTO THE SEPTUM IN ORDER TO GET IN THE RIGHT POSITION TO CROSS AND GO INTO THE LEFT ATRIUM (LA). IN THE PROCESS OF TRYING TO GET THE CORRECT PLACEMENT ON THE SEPTUM THE ACCESS SYSTEM WAS PLACED IN THE RIGHT ATRIAL APPENDAGE AND THEN DROPPED ONTO THE SEPTUM. THE PHYSICIAN WENT TO CROSS THE SEPTUM AND HEAD INTO THE LEFT ATRIUM. ONCE ACROSS THE LEFT ATRIUM, THE RF WIRE WAS INSERTED INTO THE LEFT ATRIAL APPENDAGE AND THE VERSACROSS SYSTEM WAS TAKEN OUT, NEXT THE WATCHMAN DOUBLE CURVE SHEATH WAS INSERTED. ONCE THE DOUBLE CURVE WAS INSERTED THE NON-BOSTON SCIENTIFIC PIGTAIL CATHETER OVER THE RF WIRE AND THE WIRE WAS TAKEN OUT. LA PRESSURE WAS OBTAINED AT THIS POINT, AND A CONTRAST SHOT WAS TAKEN OF THE LEFT ATRIAL APPENDAGE TO DETERMINE WHAT SIZE WATCHMAN DEVICE. THE DEVICE WAS PREPPED, T

  Patient problems: Pericardial Effusion

  MAUDE report 22170061 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION (PE) WAS NOTED. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. THERE WAS A TRACE EFFUSION NOTED BEFORE THE PROCEDURE STARTED AND IT WAS LOCATED AT THE APEX OF THE HEART. THE VERSACROSS WIRE WAS INSERTED IN THE SUPERIOR VENA CAVA (SVC), WITH THE SHEATH TO FOLLOW. THE PHYSICIAN BROUGHT THE WHOLE SYSTEM DOWN ONTO THE SEPTUM IN ORDER TO GET IN THE RIGHT POSITION TO CROSS AND GO INTO THE LEFT ATRIUM (LA). IN THE PROCESS OF TRYING TO GET THE CORRECT PLACEMENT ON THE SEPTUM THE ACCESS SYSTEM WAS PLACED IN THE RIGHT ATRIAL APPENDAGE AND THEN DROPPED ONTO THE SEPTUM. THE PHYSICIAN WENT TO CROSS THE SEPTUM AND HEAD INTO THE LEFT ATRIUM. ONCE ACROSS THE LEFT ATRIUM, THE RF WIRE WAS INSERTED INTO THE LEFT ATRIAL APPENDAGE AND THE VERSACROSS SYSTEM WAS TAKEN OUT, NEXT THE WATCHMAN DOUBLE CURVE SHEATH WAS INSERTED. ONCE THE DOUBLE CURVE WAS INSERTED THE NON-BOSTON SCIENTIFIC PIGTAIL CATHETER OVER THE RF WIRE AND THE WIRE WAS TAKEN OUT. LA PRESSURE WAS OBTAINED AT THIS POINT, AND A CONTRAST SHOT WAS TAKEN OF THE LEFT ATRIAL APPENDAGE TO DETERMINE WHAT SIZE WATCHMAN DEVICE. THE DEVICE WAS PREPPED, T

  Patient problems: Pericardial Effusion

  MAUDE report 22170008 ↗