VersaCross Connect™ LAAC Access Solution VXAK0109Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00685447019503), received between Nov 5, 2025 and Sep 22, 2026 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Off-Label Use

  It was reported that a patient experienced Cardiac Perforation and Pericardial Effusion.During withdraw for a Pulsed Field Ablation (PFA) procedure to treat atrial fibrillation a VersaCross Connect LAAC Access Solution RF wire was selected for use. Patient has Inferior Vena Cava (IVC) filter, which was difficult to gain access through. Also, patient has unusual anatomy with acute angles through IVC into right atrium. A small initial trace effusion was noted using Intracardiac Echocardiography (ICE). Physician performed transseptal procedure with versacross and Non-BSC sheath. No issue to visualize the wire. Wire tented a normal amount. After, Pulmonary Vein Isolation (PVI) and Pulmonary wall Isolation (PWI) ablation were completed with no observable complications. No malfunctions reported for BSC versacross or farawave. A resistance to move Non-BSC sheath into the right Atrium from the IVC. Nonetheless, 20 minutes post ablation, making use of ICE, a larger effusion was identified. Pericardiocentesis was performed, with not full drainage or fix of the effusion. The case was escalated to and managed by the Cardiothoracic surgeons, finding a tear, lateral & posterior IVC tear at RA ju

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 50850409 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient experienced Hypotension and Hematoma. A left atrial appendage (LAC) closure procedure was being performed. A VersaCross Connect LAAC Access Solution RF Wire was selected to use. The physician obtained groin access and advanced the wire and Watchman Access System into the Shared Virtual Console (SVC). The physician dropped onto the septum, which was visualized on Transesophageal Echocardiography (TEE). The physician was tenting at the mid portion of the interatrial septum on the bicaval view and at the mid portion of the interatrial septum on the short-axis view on the septum, and RF energy was applied to cross the septum once. The system was brought into the left side before exchanging for the pigtail catheter. The physician cannulated the appendage with the pigtail catheter and took a contrast injection. A 24 mm device was chosen and prepped as per the Directions for Use (DFU). The device was inserted into the TruSteer sheath. At the time of device insertion, the physician did not note that excessive force was applied during attempted crossing. The Echocardiologist noted a growing mass on the posterior wall of the left atrium but confirmed there was

  Patient problems: Cardiac Perforation; Hematoma; Low Blood Pressure/ Hypotension

  MAUDE report 50175681 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient experienced hematoma and hemorrhage.A VersaCross Connect LAAC Access Solution was selected for use. During the post procedure, the patient developed a lumbar artery bleed resulting in a large left retroperitoneal hemorrhage following the procedure. Imaging identified a 23 cm by 9 cm by 11 cm retroperitoneal hematoma with active arterial bleeding, likely originating from a left lumbar artery at the L4 and L5 level. The patient underwent transcatheter arterial embolization in Interventional radiology and received 3 units of Packed Red Blood Cells (PRBCs) and Fresh Frozen Plasma (FFP) for management of the bleeding. The patient was hospitalized but reported to be stable the following morning.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50077222 ↗
• InjuryMar 19, 2026Positioning Problem

  IT WAS REPORTED THAT A PERFORATION AND PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. THE PATIENT HAD A DIFFICULT VASCULAR ANATOMY SO LEFT SIDED GROIN ACCESS WAS USED. THIS MADE GETTING ON THE FOSSA DIFFICULT AND COULD NOT GET OFF THE POSTERIOR MOST PORTION OF THE SEPTUM. WHEN PUSHING THE WIRE OUT IN AN ATTEMPT TO GET BACK TO THE SUPERIOR VENA CAVA (SVC), IT WAS NOTED ON ECHO THAT THE WIRE WAS IN THE LEFT ATRIUM (LA). HOWEVER THE SHEATH AND DILATOR WERE NOT PUSHED THROUGH BUT LA ACCESS WAS CONFIRMED BY PUSHING WIRE TO THE LEFT SUPERIOR PULMONARY VEIN (LSPV). SHORTLY AFTER A TRACE EFFUSION WAS NOTICED THAT SLOWLY GREW OVER A FEW MINUTES. PROTAMINE WAS GIVEN AND THE PROCEDURE WAS CANCELLED. THE PATIENT WAS OBSERVED FOR ABOUT FORTY MINUTES. THE EFFUSION DID NOT GROW AND PATIENT REMAINED IN THE HOSPITAL, WHICH THEY HAVE BEEN ADMITTED FOR SEVERAL DAYS PRIOR TO PROCEDURE. THE FOLLOWING MORNING PHYSICIAN UPDATED THAT THE PATIENT IS DOING FINE AND EFFUSION NEVER GOT WORSE AND DID NOT NEED INTERVENTION.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 24645116 ↗
• InjuryMar 3, 2026Positioning Failure

  DURING A WATCHMAN IMPLANT PROCEDURE, THE VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR TRANSSEPTAL ACCESS. DURING TRANSEPTAL ACCESS THE VERSACROSS WAS USED AS NORMAL. IT WAS NOTED THAT THE WIRE WAS IN CLOSE PROXIMITY TO THE AORTA SO IT WAS MOVED MORE POSTERIOR TO AVOID. UPON BUZZING ACROSS THE DILATOR SLIPPED AND THE HOT WIRE BOVIED THROUGH THE AORTA. THIS RESULTED IN AN AORTIC PERFORATION AND A HEMATOMA ON THE NON CORONARY CUSP. HEPARIN WAS REVERSED, AND THE WATCHMAN DEVICE WAS NOT IMPLANTED. THE PATIENT UNDERWENT CT IMAGING AND WAS TRANSFERRED TO THE ICU FOR MONITORING. NO SURGICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS ADMITTED FOR OBSERVATION WITH PLANS FOR REASSESSMENT THE FOLLOWING DAY. THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY. THE DEVICE IS NOT EXPECTED TO BE RETURN DUE TO DISPOSAL.

  Patient problems: Hematoma; Perforation of Vessels

  MAUDE report 24497245 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. WHEN THE PHYSICIAN ATTEMPTED TO CROSS THE SEPTUM, THERE WAS NO VISIBLE TENT SEEN ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE PHYSICIAN WAS NOTIFIED AND DECIDED TO CROSS THE SEPTUM. WITHIN THIRTY SECONDS OF COMING ON WITH ENERGY, A SIZEABLE EFFUSION WAS NOTICED. THE PHYSICIAN THEN PERFORMED A TAP TO DRAIN THE BLOOD FROM THE PERICARDIAL SPACE. THE PATIENT WAS CONNECTED TO A DRAIN, STABILIZED AND TRANSPORTED TO THE INTENSIVE CARE UNIT. THE PATIENT IS EXPECTED TO BE DISCHARGED WITHIN A FEW DAYS AND IS RECOVERING WELL. IN THE PHYSICIAN OPINION, WHEN THE PHYSICIAN WAS ATTEMPTING TO CROSSING THE SEPTUM HE PUNCTURED SOMETHING BESIDES THE SEPTUM CAUSING THE PATIENT TO HAVE A LARGE PERICARDIAL EFFUSION. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 24260368 ↗
• MalfunctionJan 5, 2026Off-Label Use; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE TO TREAT ATRIAL FIBRILLATION VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT PHYSICIAN GOT ACCESS AT START OF CASE AND TRIED ADVANCING RF 0.035 J WIRE THROUGH ACCESS NEEDLE AND KEPT HAVING TROUBLE, WHEN REMOVED THE TIP OF WIRE WAS SHREDDED AND FRAYED. THE OUTSIDE COATING OR CORE OF WIRE WAS DESTROYED. THE PHYSICIAN WAS UNAWARE OF ANY TORTUOSITY OR BLOCKAGE IN RIGHT FEMORAL VEIN. PATIENT DIDN'T HAVE ANY ISSUES AT GROIN SITE. WIRE AND PIECE WERE REMOVED SUCCESSFULLY. THE PROCEDURE WAS FINISHED USING A NEW 0.035 J TIP 180CM VERSA CROSS CONNECT RF WIRE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED. THE PRODUCT IS NOT EXPECTED TO BE RETURNED AS IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959045 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ARRHYTHMIA AND BRADYCARDIC. A VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR WATCHMAN LAA CLOSURE PROCEDURE. DURING THE PROCEDURE WHEN THE PHYSICIAN MADE AN ATTEMPT REMOVE THE DILATOR TO RESHAPE IT, THE PATIENT EXPERIENCED BRADYCARDIC. IMMEDIATELY, ATROPINE WAS GIVEN TO THE PATIENT AND CPR (CARDIOPULMONARY RESUSCITATION) WAS GIVEN FOR LESS THAN 1 (ONE) MINUTE. HOWEVER, NO SHOCK WAS REQUIRED. HEART RATE WAS RECOVERED AND THE PATIENT WAS MONITORED FOR SEVERAL MINUTES. AS PER THE PHYSICIAN OPINION, THEY MIGHT HAVE HIT THE AV NODE (ATRIOVENTRICULAR) WHILE REMOVING THE DEVICE. ONCE THE PATIENT HEART RATE WAS RECOVERED, THE PHYSICIAN PROCEEDED WITH WATCHMAN IMPLANT WITHOUT ADDITIONAL COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPLACEMENT OF THE DEVICE. THE PATIENT IS NOW FULLY RECOVERED. ATROPINE WAS GIVEN AND PATIENT HAD THE HISTORY OF HEART BLOCK. THE PATIENT WAS ONLY HOSPITALIZED FOR OBSERVATION. THE DEVICE IS NOT EXPECTED TO BE RETURN AS DISPOSED.

  Patient problems: Arrhythmia; Bradycardia

  MAUDE report 23649497 ↗
• MalfunctionNov 13, 2025Positioning Failure; Difficult to Advance; Positioning Failure; Difficult to Advance

  IT WAS REPORTED THE PATIENT EXPERIENCED PAIN. DURING AN LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. THE PHYSICIAN WENT UP WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER AND VERSACROSS CONNECT. THE PATIENT'S HEART WAS VERY ROTATED AND PATIENT WAS YELLING OUT IN PAIN THE WHOLE TIME WITH EVERY MANIPULATION OF THE CATHETER. THE FIRST ATTEMPT FOR TRANSSEPTAL WAS ATTEMPTED BUT WAS UNSUCCESSFUL. IT WAS THEN ATTEMPTED TO REPOSITION AND DID A SUCCESSFUL TRANSSEPTAL. AFTER THE SECOND TRANSSEPTAL AND CROSSING WITH SHEATH AND ICE, THE PATIENT BEGAN TO COUGH UP BLOOD. THE PHYSICIAN PAUSED THE PROCEDURE. SUCTION TO GET BLOOD WAS PERFORMED AND A WEDGE UNDER THE PATIENT WAS PLACED. AFTER A FEW MINUTES THE PATIENT SEEM TO STABILIZE AND THE PHYSICIAN DECIDED TO PROCEED AND COMPLETE PROCEDURE. THE PATIENT IS EXPECTED TO RECOVER FULLY. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: Hemoptysis; Pain

  MAUDE report 23544913 ↗
• InjuryNov 5, 2025Device Sensing Problem; Adverse Event Without Identified Device or Use Problem; Device Sensing Problem; Adverse Event Without Identified Device or Use Problem

  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, TWO OF A VERSACROSS CONNECT LAAC WERE SELECTED FOR USE. A TRUSTEER ACCESS SHEATH WAS USED WITH A J-TIP VERSACROSS CONNECT FOR THE PROCEDURE. THE TRANSSEPTAL STICK APPEARED TO BE MID/MID LOCATION ON THE SEPTUM. A PERFORATION OF THE LEFT ATRIUM POSTERIOR WALL AND LEFT ATRIAL APPENDAGE (LAA) OCCURRED FOLLOWING TRANSEPTAL. A PRESSURE DROP WAS NOTICED AND A GLOBAL PERICARDIAL EFFUSION WAS NOTED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE CARDIAC SURGEON WAS CALL AND THE PATIENT WAS TAKEN TO SURGERY WHERE THEY REPAIRED TWO PERFORATIONS AND ONCE THE PATIENT WAS STABILIZED THE APPENDAGE WAS CLIPPED. THE PATIENT DID WELL FOLLOWING SURGERY AND IS EXPECTED TO MAKE A FULL RECOVERY. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). IT WAS FURTHER CONFIRMED THAT THE KIT VXAK0109 WAS USED FOR THIS PROCEDURE. IMAGING WAS DIFFICULT FOR THIS CASE DUE TO HEART ROTATION. RF WIRE WAS SUSPECTED CAUSE FOR PERFORATION, POSSIBLY DILATOR ALSO. IN THE PHYSICIAN OPINION, DIFFICULT IMAGING LEAD TO SUBOPTIMAL

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

  MAUDE report 23480424 ↗