VersaCross Connect LAAC Access Solution VXAK0005 (REF NA)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00685447010517), received between Jan 9, 2025 and Jul 2, 2026 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2026Positioning Failure; Device Sensing Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED. IT WAS REPORTED THAT VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS PERFORMED. PRE-PROCEDURAL TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) REVEALED A LIPOMATOUS AND ANEURYSMAL INTERATRIAL SEPTUM. THE PHYSICIAN INITIATED THE TRANSSEPTAL PUNCTURE (TSP) USING A VERSACROSS CONNECT WITH THE TRUSTEER SHEATH TO ACCESS THE SEPTUM. HOWEVER, THE IMAGER WAS UNABLE TO VISUALIZE SEPTAL TENTING IN THE STANDARD TEE VIEWS, AND THE AVAILABLE IMAGES MADE IT DIFFICULT TO IDENTIFY THE EXACT LOCATION OF TENTING. AFTER THREE UNSUCCESSFUL ATTEMPTS TO ADVANCE, THE PHYSICIAN DECIDED TO SWITCH TO A STANDARD VERSACROSS ACCESS SYSTEM. DURING PREPARATION OF THE NEW SYSTEM, IMPROVED IMAGING VIEWS WERE OBTAINED. A PIGTAIL WIRE WAS ADVANCED AFTER ENTERING THE RIGHT ATRIAL APPENDAGE, AND SUCCESSFUL TSP ACCESS WAS ACHIEVED. THE PIGTAIL WIRE WAS THEN POSITIONED IN THE LEFT ATRIAL APPENDAGE (LAA). THE VERSACROSS SHEATH WAS EXCHANGED FOR THE TRUSTEER SHEATH, AND THE DILATOR WAS REMOVED. THE PIGTAIL WIRE WAS SUBSEQUENTLY EXCHANGED FOR A PIGTAIL CATHETER, AND AN APPENDOGRAM WAS PERFORMED. AT THAT TIME, THE IMAGER NO

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 25692957 ↗
• InjuryDec 11, 2025Positioning Failure; Device Sensing Problem; Positioning Failure; Device Sensing Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) AND HEMATOMA OCCURRED. DURING A WATCHMAN IMPLANT PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. THERE WAS NO EFFUSION NOTED PRIOR TO PROCEDURE. DURING PRE-PROCEDURE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), THE INTERATRIAL SEPTUM (IAS) WAS NOTED TO BE DIFFUSELY THICK WITH ONLY A SMALL 0.5-1.0CM THIN PORTION LOCATED ANTERIORLY, AND THE TEAM ANTICIPATED THAT TRANSSEPTAL PUNCTURE (TSP) WOULD BE CHALLENGING. THE PHYSICIAN ATTEMPTED TSP USING THE WATCHMAN TRUSTEER ACCESS SYSTEM (WAS) WITH THE VERSACROSS CONNECT. MULTIPLE ATTEMPTS WERE MADE OVER 30-40 MINUTES TO OBTAIN A PERPENDICULAR TENT ON THE THIN PORTION OF THE IAS. ONE ANTERIOR/MID TSP ATTEMPT WAS PERFORMED YET BUBBLES AND THE VERSACROSS WIRE REMAINED ON THE RIGHT ATRIAL SIDE, CONFIRMING UNSUCCESSFUL CROSSING. ONCE A PERPENDICULAR TENT POSITION WAS AGAIN VISUALIZED (MID IN THE BICAVAL VIEW AND ANTERIOR IN SHORT AXIS), A SINGLE RADIOFREQUENCY (RF) PULSE WAS DELIVERED. NO WIRE OR BUBBLES WERE VISUALIZED IN THE LEFT ATRIUM (LA), ALTHOUGH THE PHYSICIAN BELIEVED THE WIRE CROSSING ON FLUOROSCOPY. THE PHYSICIAN ADVANCED THE WAS AND VERSACROSS DILATOR. TEE THEN REVEALED THAT THE WAS

  Patient problems: Hematoma; Pericardial Effusion

  MAUDE report 23778844 ↗
• InjuryDec 11, 2025Device Sensing Problem; Difficult to Advance; Device Sensing Problem; Difficult to Advance

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) AND HEMATOMA OCCURRED. DURING A WATCHMAN IMPLANT PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. THERE WAS NO EFFUSION NOTED PRIOR TO PROCEDURE. DURING PRE-PROCEDURE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), THE INTERATRIAL SEPTUM (IAS) WAS NOTED TO BE DIFFUSELY THICK WITH ONLY A SMALL 0.5-1.0CM THIN PORTION LOCATED ANTERIORLY, AND THE TEAM ANTICIPATED THAT TRANSSEPTAL PUNCTURE (TSP) WOULD BE CHALLENGING. THE PHYSICIAN ATTEMPTED TSP USING THE WATCHMAN TRUSTEER ACCESS SYSTEM (WAS) WITH THE VERSACROSS CONNECT. MULTIPLE ATTEMPTS WERE MADE OVER 30-40 MINUTES TO OBTAIN A PERPENDICULAR TENT ON THE THIN PORTION OF THE IAS. ONE ANTERIOR/MID TSP ATTEMPT WAS PERFORMED YET BUBBLES AND THE VERSACROSS WIRE REMAINED ON THE RIGHT ATRIAL SIDE, CONFIRMING UNSUCCESSFUL CROSSING. ONCE A PERPENDICULAR TENT POSITION WAS AGAIN VISUALIZED (MID IN THE BICAVAL VIEW AND ANTERIOR IN SHORT AXIS), A SINGLE RADIOFREQUENCY (RF) PULSE WAS DELIVERED. NO WIRE OR BUBBLES WERE VISUALIZED IN THE LEFT ATRIUM (LA), ALTHOUGH THE PHYSICIAN BELIEVED THE WIRE CROSSING ON FLUOROSCOPY. THE PHYSICIAN ADVANCED THE WAS AND VERSACROSS DILATOR. TEE THEN REVEALED THAT THE WAS

  Patient problems: Hematoma; Pericardial Effusion

  MAUDE report 23778821 ↗
• InjuryDec 10, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A CARDIAC TAMPONADE, PERICARDIAL EFFUSION (PE) AND PERFORATION OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN FLX PRO PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. PATIENT'S SEPTAL ANATOMY WAS CHALLENGING TO VISUALIZE; AFTER MINUTES OF CONFIRMING SAFE TRANSEPTAL LOCATION AN RADIO FREQUENCY (RF) APPLICATION WAS PERFORMED AND THE WIRE CROSSED THE SEPTUM. HOWEVER, THE WIRE WENT INTO A TRANSVERSE SINUS AREA LEADING TO BLOOD GETTING INTO THE PERICARDIUM CAUSING A HOLE APPROXIMATELY .035' POSTERIOR TO THE AORTA. THE PATIENT WAS OBSERVED TO BE DEVELOPING AN EFFUSION AND EVENTUALLY DEVELOPED TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 450CC OF BLOOD WAS ASPIRATED FROM THE PERICARDIUM. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS BROUGHT TO THE INTENSIVE CARE UNIT (ICU) FOR FURTHER OBSERVATION. AFTER THIRTY (30) MINUTES TO AN HOUR HAD GONE BY, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED TO REASSESS THE EFFUSION. UNFORTUNATELY THE EFFUSION CAME BACK AND THE PATIENT WAS TAKEN TO THE OPERATION ROOM WHERE THE CARDIOTHORACIC SURGEON REPAIRED THE HOLE AND LIGATED THE APPENDAGE WITH AN ATRICLIP. THE PATIENT IS EXPECTED TO FU

  Patient problems: Cardiac Tamponade; Perforation of Vessels; Pericardial Effusion

  MAUDE report 23773807 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A THROMBUS HAS OCCURRED. IT WAS THAT DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. AFTER CROSSING THE SEPTUM, A THROMBUS FORMATION WAS SUSPECTED LOCATED ON THE VERSACROSS RF WIRE. THE RF WIRE WAS REMOVED, BLOOD WAS ASPIRATED THROUGH THE SHEATH REVEALING A THROMBUS. ACTIVATED CLOTTING TIME (ACT) WAS 314, PATIENT WAS GIVEN 10,000 UNIT OF HEPARIN PLUS ADDITIONAL HEPARIN DURING PROCEDURE. NO FURTHER COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23065952 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED ST ELEVATION LEADING TO AIR EMBOLISM. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT LAAC KIT WAS SELECTED FOR USE. THE PHYSICIAN PERFORMED TRANSSEPTAL PUNCTURE AT INFERIOR MID LOCATION. THE WATCHMAN SHEATH WAS THEN ADVANCED, AND A WATCHMAN DEVICE WAS DEPLOYED AND IMPLANTED SUCCESSFULLY. AT SOME POINT DURING PROCEDURE, THERE WAS SOME VISIBLE AIR ON FLUORO, BUT THE PHYSICIAN WAS NOT SURE WHERE IT COULD HAVE COME FROM. THE TECH FLUSHED THE DEVICE ADEQUATELY AND IT WAS DOUBLE CHECKED BY PHYSICIAN. IT WAS ALSO CONFIRMED THAT A WET-TO-WET CONNECTION WAS DONE HOWEVER THE PHYSICIAN IS UNSURE WHERE THE AIR CAME FROM. THE ST ELEVATIONS WERE PRESENT FOR A REALLY SHORT PERIOD OF TIME, BUT THE PATIENT WENT BACK TO SINUS AND WAS STABLE AT THE END OF THE PROCEDURE. THE PATIENT IS EXPECTED TO FULLY RECOVER AND WAS KEPT FOR AN OVERNIGHT STAY. PATIENT WAS STABLE AND LATER DISCHARGED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). A HALF DOSE OF HEPARIN WAS GIVEN BEFORE TRANSSEPTAL PUNCTURE (TSP) AND HALF DOSE AFTER. PATIENT HAD PECTUS EXCAVATUM MEANING HEART WAS COMPLETELY ROTATED, CAUSING TRANSSEPTAL TO BE

  Patient problems: Air Embolism; Non specific EKG/ECG Changes

  MAUDE report 21860830 ↗
• MalfunctionApr 1, 2025Use of Device Problem; Difficult to Advance; Material Integrity Problem; Use of Device Problem; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE FOR ATRIAL FIBRILLATION TREATMENT, A VERSACROSS CONNECT LAAC KIT WAS SELECTED FOR USE. THE USER INSERTED THE RF WIRE THROUGH A NEEDLE/SHEATH. AFTER FEW ADVANCES, THERE WAS SOME RESISTANCE NOTED ON THE WIRE. WHEN THE WIRE WAS PULLED OUT, THE TIP DAMAGE WAS NOTED. A COATING ISSUE NOTED THUS, THE WIRE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21740593 ↗
• MalfunctionJan 27, 2025Defective Device; Defective Device

  IT HAS BEEN REPORTED THAT A VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A WATCHMAN PROCEDURE. DURING PREPARATION, IT WAS MENTIONED THAT THE TIP OF THE DILATOR WAS NOTED TO BE DAMAGED PRIOR TO INSERTION INTO THE SHEATH. A NEW KIT WAS THEN OPENED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DILATOR WAS NOT RESHAPED PRIOR TO THE DAMAGE BEING NOTED. NO PATIENT COMPLICATIONS WERE REPORTED. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21242102 ↗
• MalfunctionJan 9, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT LAAC KIT WAS SELECTED FOR USE. IT WAS NOTED THAT THE VERSACROSS RF WIRE DID NOT PUNCTURE THE SEPTUM. HENCE, THE WIRE WAS REPLACED, AND IT WORKED FINE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. PRODUCT IS NOT RETURNING FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118445 ↗