VersaCross Connect™ LAAC Access Solution VXAK0101Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00685447019466), received between Jun 30, 2025 and Sep 1, 2026 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Positioning 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pericardial Effusion

  MAUDE report 50543686 ↗
• MalfunctionNov 13, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT VERSACROSS CONNECT LAAC ACCESS SOLUTION SELECTED FOR USE. IT WAS MENTIONED THAT NO EFFECT NOS NOTED WHEN ENERGY (RF) WAS DELIVERED. NO FURTHER INFORMATION WAS PROVIDED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED FOR RETURN AS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544919 ↗
• InjuryOct 29, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) OCCURRED. DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. PRIOR TO PROCEDURE, THERE WAS A SMALL EFFUSION BEFORE THE PROCEDURE THAT QUICKLY GREW. THE PHYSICIAN WAS EXPERIENCING ADVANCING THE WIRE CHALLENGING FROM THE INFERIOR VENA CAVA (IVC) TO THE SUPERIOR VENA CAVA (SVC). THE J-WIRE (RF WIRE) PERFORATED THE RIGHT ATRIUM. THE PATIENT CHEST WAS TAPPED. THE PE WAS NOTED FIRST AND THEN TRANSSEPTAL PUNCTURE (TSP) WAS PERFORMED. THE PATIENTS ANATOMY WAS VERY CHALLENGING TO GET FROM THE IVC TO THE SVC AND TOOK MULTIPLE ATTEMPTS. AFTER A SHORT PERIOD OF TIME THE PATIENT BECAME TACHYCARDIC AND HYPOTENSIVE AND REQUIRED A TAP BUT NO FURTHER INTERVENTION. THE VERSACROSS DILATOR WAS PRE-SHAPED AND WAS NOT DIFFICULT TO ADVANCE AND ONLY TOOK ONE ATTEMPT TO POSITION. THE PATIENT WAS HOSPITALIZED AND LATER DISCHARGED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

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

  MAUDE report 23414489 ↗
• MalfunctionSep 19, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT THE INNER PACKAGING ON THE VERSACROSS SPLIT AS THE PACKAGE WAS BEING OPENED IN THE CLEAR PORTION OF THE PACKAGE. THERE WAS NO BOX DAMAGE NOTED AND NO INNER DEVICES DAMAGED. THE PACKAGING TORE IN THE INCORRECT LOCATION. THIS WAS REPLACED WITH ANOTHER VERSACROSS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (CONTAMINATED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094744 ↗
• InjurySep 17, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PERFORATION, PERICARDIAL EFFUSION AND CARDIAC TAMPONADE OCCURRED, AND PROCEDURE WAS ABORTED. IT WAS REPORTED THAT VERSACROSS CONNECT LAAC ACCESS SOLUTION SELECTED FOR LAAC PROCEDURE. NO TRACE OF PERICARDIAL EFFUSION WAS NOTED PRIOR TO THE PROCEDURE. DURING PREPARATION FOR TRANSSEPTAL CROSSING, A PERICARDIAL EFFUSION WAS DISCOVERED. THE VERSACROSS RF WIRE WAS ADVANCED AND PULLED BACK MORE THAN ONCE TO GET INTO POSITION. NO OTHER DIFFICULTY WAS NOTED DURING TRANSSEPTAL. PROTAMINE WAS GIVEN AND PERICARDIOCENTESIS WAS PERFORMED. APPROXIMATELY ONE LITER OF FLUID WAS REMOVED. ONCE THE PATIENT WAS STABLE, THEY WERE MOVED TO A SURGICAL SUITE TO DETERMINE THE CAUSE OF THE INCIDENT, AND A SMALL PERFORATION WAS FOUND IN THE RIGHT ATRIUM, WHICH WAS SUTURED CLOSED. THE LEFT ATRIAL APPENDAGE WAS CLIPPED AND PATIENT RECOVERED. THE PROCEDURE WAS ABORTED. A CARDIAC TAMPONADE WAS ALSO REPORTED. THE PATIENT REMAINS HOSPITALIZED AND WAS DISCHARGED ON (B)(6) 2025. NO MALFUNCTION WAS REPORTED. THE DEVICE IS NOT EXPECTED TO RETURN FOR ANALYSIS AS DISPOSED. IN THE PHYSICIAN'S OPINION, HE CREATED THE PERICARDIAL EFFUSION BY PERFORATING THE RIGHT ATRIUM WITH THE VERSACROSS PRODUCT.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 23077595 ↗
• InjuryAug 13, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS NOTED A CARDIAC TAMPONADE AND PERICARDIAL EFFUSION (PE) OCCURRED. DURING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. INTRACARDIAC ECHOCARDIOGRAM (ICE) IMAGING WAS BEING USED AND CONFIRMED THERE WAS NOT A PRE-EXISTING EFFUSION PRESENT. VENOUS ACCESS WAS OBTAINED AND TRANSSEPTAL PUNCTURE (TSP) WAS PERFORMED. THERE WAS DIFFICULTY VISUALIZING THE WIRE ON ICE. THE WIRE WAS TENTING. DIFFICULTY OF RA ANATOMY NOT SO MUCH TSP WORKFLOW. AFTER TSP, A SMALL PE BECAME VISIBLE ON ICE, AND THE PHYSICIAN DETERMINED THIS WAS DUE TO ICE CATHETER MANIPULATION DURING TSP. THE PATIENT REMAINED STABLE. A WATCHMAN FLX PRO DELIVERY SYSTEM AND CLOSURE DEVICE (WDS) WAS INSERTED AND THE CLOSURE DEVICE WAS IMPLANTED IN THE LEFT ATRIAL APPENDAGE (LAA). AFTER RELEASE OF THE CLOSURE DEVICE, HYPOTENSION WAS NOTED. AN EFFUSION SWEEP WAS PERFORMED AND A NOTICEABLY LARGER PE WAS PRESENT AT THE VENTRICLES IN THE PERICARDIUM. A PERICARDIOCENTESIS WAS PERFORMED, WITH 185CC OF FLUID REMOVED. PERICARDIAL DRAIN AND CHEST TUBE WAS PLACE. THE PROCEDURE WAS CONCLUDED. THE PATIENT WAS ADMITTED TO THE CORONARY CARE UNIT (CCU) FOR OVERNIGHT OBSERVATION AND THREE UNITS

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

  MAUDE report 22796848 ↗
• InjuryAug 13, 2025Display or Visual Feedback Problem; Positioning Problem; Display or Visual Feedback Problem; Positioning Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. NO TRACE OF EFFUSION WAS NOTED PRIOR TO THE PROCEDURE. THE PHYSICIAN WAS TRYING TO GET TRANSSEPTAL ACCESS AND WAS HAVING A HARD TIME SEEING THE VERSACROSS WIRE ON THE SEPTUM VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE PHYSICIAN ATTEMPTED TO RADIO FREQUENCY ACROSS AND THE WIRE WAS IN THE LEFT ATRIUM, BUT WAS NOT MANIPULATING INTO THE LEFT UPPER PULMONARY VEIN (LUPV) LIKE NORMAL. UPON MANEUVERING THE TEE TO GET A BETTER VISUALIZATION, A PERICARDIAL EFFUSION WAS NOTED AND PROCEDURE ADVANCEMENT WAS STOPPED. THE PE WAS CIRCUMFERENTIAL AROUND THE HEART, BUT MAIN AREA WAS NEAR RIGHT VENTRICLE AND LEFT VENTRICLE AS PER TEE. THE PATIENT WAS ACCESSED FOR NEED OF PERICARDIAL TAP. IT WAS DETERMINED THAT WOULD BE BEST AND TAP WAS PERFORMED. A DRAIN WAS LEFT IN PLACE AND PATIENT WAS ADMITTED TO THE INTENSIVE CARE FOR EVALUATION POST PROCEDURE. THE PATIENT WAS HEMODYNAMICALLY STABLE DURING THE DURATION OF THE PERICARDIAL TAP AND POST PROCEDURE. THE PROCEDURE WAS CANCELLED. THE DEVICE IS NOT EXPECTED TO BE

  Patient problems: Pericardial Effusion

  MAUDE report 22796810 ↗
• MalfunctionJul 14, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR PULMONARY VEIN ISOLATION. DURING THE PROCEDURE WHEN VERSACROSS CONNECT FOR FARADRIVE WAS INSERTED INTO THE BODY FOR SHEATH EXCHANGE FROM ACCESS SHEATH TO FARADRIVE SHEATH FOR TRANSSEPTAL PUNCTURE (TSP), THE VERSACROSS WIRE TIP TANGLED ON ITSELF AND WAS NOT ABLE TO FREED UP WITH MANEUVERING BY PHYSICIAN. THUS, A NEW VERSCROSS KIT WAS OPENED TO BE USED. HENCE, THE TIP OF THE DILATOR APPEARED TO BE FOLDED BACK A SMALL AMOUNT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURN FOR ANALYSIS (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22495175 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CARDIAC TAMPONADE AND PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. PRE-PROCEDURE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED AND A SMALL EXISTING PE WAS IDENTIFIED. AFTER THE FEMORAL VEIN ACCESS, A FULL DOSE OF HEPARIN WAS GIVEN. THE TRANSSEPTAL PUNCTURE (TSP) WAS COMPLETED AND THE VERSACROSS RF WIRE WAS PLACED IN THE LEFT SUPERIOR PULMONARY VEIN. THE RESULTING ACTIVATED CLOTTING TIME (ACT) WAS 366. THE WATCHMAN ACCESS SHEATH (WAS) WAS ADVANCED INTO THE LEFT ATRIUM. A NON-BOSTON SCIENTIFIC PIGTAIL CATHETER WAS INSERTED AND ADVANCED INTO THE LEFT ATRIAL APPENDAGE (LAA). IT WAS FELT THAT THE PIGTAIL CATHETER WAS SEATED A BIT DEEP UPON FIRST CONTRAST SHOT. THE PHYSICIAN WAS ADVISED TO BRING THE PIGTAIL CATHETER BACK TO THE MIDDLE OF THE LAA. ANOTHER CONTRAST SHOT WAS TAKEN AND SIZING WAS DETERMINED. THERE WAS NEVER A SIGN OF CONTRAST SEEN IN PERICARDIUM ON FLUOROSCOPY IMAGING. A 20MM WATCHMAN FLX PRO CLOSURE DEVICE AND DELIVERY SYSTEM WAS INSERTED INTO THE WAS AND IMMEDIATELY AFTER INSERTION AN ANTERIOR LAA, PE WAS NOTED SO THE PROC

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

  MAUDE report 22438229 ↗
• InjuryJun 30, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THERE WAS A PERICARDIAL EFFUSION. THE PROCEDURE WAS CANCELLED. DURING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. THE PHYSICIAN GAINED ACCESS TO THE PATIENT AND THEN INSERTED THE VERSACROSS CONNECT ALONG WITH THE WATCHMAN SHEATH. THE PHYSICIAN MADE SEVERAL ATTEMPTS AT PERFORMING THE TRANSSEPTAL PUNCTURE BUT WAS NOT SUCCESSFUL, DUE TO ANATOMY AND LENGTH OF REACHING SEPTUM. INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING SHOWED THAT THERE WAS A PERICARDIAL EFFUSION IN THE RIGHT VENTRICLE. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS MONITORED. FOUR (4) HOURS POST PROCEDURE TRANSTHORACIC ECHOCARDIOGRAM IMAGING SHOWED THAT THE PERICARDIAL EFFUSION HAD RESOLVED. THE PATIENT REMAINED IN THE HOSPITAL OVERNIGHT FOR OBSERVATION AND WAS DISCHARGED HOME THE NEXT DAY FULLY RECOVERED FROM THIS EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). NO PERICARDIAL EFFUSION WAS NOTED ON THE ECHO BEFORE THE PROCEDURE. THE PATIENT WAS NOT UNDER WARFARIN AT THE TIME, NOR ANTIPLATELET DRUGS. NO RADIO FREQUENCY WAS APPLIED WITH VERSACROSS RF WIRE. THE PHYSICIAN JUST HAD PROBLEMS REACHING AND ST

  Patient problems: Pericardial Effusion

  MAUDE report 22362317 ↗