VersaCross Connect LAAC Access Solution VXAK0001 (UDI 00685447018339)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00685447018339), received between Nov 8, 2024 and Apr 17, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2026Difficult to Advance; Physical Resistance/Sticking

  A FISSURE AND FISTULA OCCURRED. IT WAS REPORTED THAT VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR USE DURING A WATCHMAN PROCEDURE. DURING TRANSSEPTAL ACCESS, THE SEPTUM WAS CROSSED IN LOW ANTERIOR POSITION. THE VERSACROSS WIRE INITIALLY ENCOUNTERED THE RESISTANCE, DIFFICULT TO ADVANCE FELT LIKE STUCK AND WAS REPOSITION WITHOUT FURTHER ISSUE. THE SHEATH AND DILATOR WERE THEN ADVANCED SUCCESSFULLY COMPLETED. POST PROCEDURE IMAGING TEE IDENTIFIED A SMALL JET FROM AORTIC ROOT INTO THE LEFT ATRIUM, CONSISTENT WITH FISSURE AND FISTULA. THE PATIENT REMAINED STABLE WITH NO HEMODYNAMIC COMPLICATIONS AND FOLLOW UP WAS PLANNED. PATIENT WAS REPORTED TO BE STABLE WITH PLANS FOR A SIX WEEK TO RECHECK. THE PROCEDURE WAS COMPLETED WITH ORIGINAL DEVICE. THE PATIENT PLANNED WAS TO BE DISCHARGED ON (B)(6) 2026.

  Patient problems: Fistula; Perforation of Vessels

  MAUDE report 24916882 ↗
• MalfunctionMar 24, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT FOR LAAC WAS SELECTED FOR USE. AFTER OPENING THE DEVICE AND PREPARED IT, PRIOR TO INSERTING INTO THE SHEATH, THE PHYSICIAN DISCOVERED A LIFTED TIP OF THE DILATOR. THE ORIGINAL DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY ISSUE. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678575 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION (PE) AND CARDIAC TAMPONED OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT FOR LAAC KIT WAS SELECTED FOR USE. THE PHYSICIAN USED THE WATCHMAN DOUBLE CURVE SHEATH WITH THE VERSACROSS CONNECT DILATOR OVER THE VERSACROSS RF WIRE FOR TRANSSEPTAL PUNCTURE (TSP). THE TSP WAS PERFORMED SUCCESSFULLY IN AN INFERIOR/ANTERIOR LOCATION ON THE SEPTUM. THE VERSACROSS RF WIRE WAS PLACED ACROSS INTO THE LEFT ATRIAL APPENDAGE (LAA). THE PHYSICIAN WAS HAVING DIFFICULTY TO CROSS THE SEPTUM WITH THE WATCHMAN SHEATH UNDER INTRACARDIAC ECHOCARDIOGRAPHY (ICE) GUIDANCE AND REQUESTED FOR TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) GUIDANCE. THE PHYSICIAN WAS THEN ABLE TO CROSS THE SHEATH AND AT THIS TIME, IT WAS NOTED THAT THE PATIENT BLOOD PRESSURE DROPPED AND MEDICATIONS WAS GIVEN TO THE PATIENT. THE TEE OPERATOR ASSESSED FOR EFFUSION WHICH WAS NOTICED POST SHEATH CROSSING. THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE AND REMOVED THE SHEATH AND VERSACROSS RF WIRE. AN APPROXIMATE OF 350ML BLOOD REMOVED AND PERICARDIAL DRAIN WAS PLACED. THE PATIENT WAS STABLE AT END OF PROCEDURE AND WAS TAKEN TO INT

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

  MAUDE report 20821366 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT FOR LAAC KIT WAS SELECTED FOR USE. A SMALL EFFUSION WAS NOTED PRIOR TO THE PROCEDURE. THE PHYSICIAN GAINED FEMORAL ACCESS. THE WATCHMAN TRUSTEE ACCESS SHEATH AND VERSACROSS CONNECT SYSTEM WAS INSERTED FOR TRANSSEPTAL PUNCTURE ALONG WITH A NON-BOSTON SCIENTIFIC INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER. THE TRANSSEPTAL PUNCTURE (TSP) WAS PERFORMED IN AN INFERIOR/MID ANTERIOR POSITION WITH NO ISSUES. THE PHYSICIAN ATTEMPTED CROSSING THE ICE CATHETER INTO THE LEFT ATRIUM, BUT WAS UNSUCCESSFUL AND DURING THIS ATTEMPT, A PERICARDIAL EFFUSION WAS NOTED ON THE POSTERIOR SIDE OF THE HEART. PERICARDIAL EFFUSION WAS CONFIRMED VIA CONTRAST INJECTION SHOWING CONTRAST IN THE PERICARDIUM BUT NOT SURROUNDING THE LEFT ATRIAL APPENDAGE (LAA). PATIENT'S BLOOD PRESSURE DROPPED APPROXIMATELY 20 MM/HG AND WAS MAINTAINED WITH IV FLUIDS. PROTAMINE WAS GIVEN AND THE WATCHMAN SHEATH WAS REMOVED TO THE RIGHT SIDE OF THE HEART. THE EFFUSION WAS MONITORED FOR FORTY-FIVE MINUTES WITH NO INCREASE IN SIZE. THE PHYSICIAN DISCONTINUES THE PROCEDURE DESP

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 20688058 ↗
• InjuryNov 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR USE DURING A LEFT ATRIUM APPENDAGE CLOSURE. WHEN PERFORMING THE TRANSSEPTAL PUNCTURE, THE VERSACROSS DILATOR BECAME CAUGHT ON THE ATRIAL PACING LEAD AND PULLED THE LEAD OUT OF PLACE, CAUSING ITS DISLODGEMENT. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THE PATIENT EXPERIENCE BRADYCARDIA: PATIENT'S INTRINSIC RATE WAS 54BPM. THE PATIENT IS EXPECTED TO FULLY RECOVER AND DISCHARGED LATER ON. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). A REPOSITIONING OF THE LEAD WILL BE SCHEDULED. NO OTHER INTERVENTIONS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 20641509 ↗