VersaCross Connect™ LAAC Access Solution VXAK0105Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00685447019480), received between May 12, 2025 and Sep 29, 2026 — classified as 1 death, 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient experienced a thrombus.It was reported that during a WATCHMAN FLX Pro procedure to treat Left Atrial Appendage Closure (LAAC) a VersaCross Connect LAAC Access Solution was selected for use for transseptal access. The physician went into the body with the pigtail wire, followed by the double curve Watchman sheath and dilator, when waiting to go transseptal it was noticed a clot on the wire. It was noticed the dilator tip was damaged, so it replaced with a new Versacross connect. Then went back up and continued the procedure as normal, procedure was completed with no patient consequences observed. The Activated Clotting Time (ACT) resulted 215 and it was given 10,000 more units of heparin. The irrigation flow was not interrupted during procedure. It was then pulled everything back and flushed everything out. Irrigation flow rate is unknown. TEE was used to rule out thrombus before the procedure. It is unknown if procedure performed was interrupt on anticoagulation regime. Time passed between initial ACT and last ACT recorded is unknown. Following ACT was greater than 400. No fibrin or coagulant was seen at the tip of the catheter. Anticoagulation status

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50936655 ↗
• InjurySep 29, 2026Nonstandard Device

  It was reported that a patient experienced a thrombus.It was reported that during a WATCHMAN FLX Pro procedure to treat Left Atrial Appendage Closure (LAAC) a VersaCross Connect LAAC Access Solution was selected for use for transseptal access. The physician went into the body with the pigtail wire, followed by the double curve Watchman sheath and dilator, when waiting to go transseptal it was noticed a clot on the wire. It was noticed the dilator tip was damaged, so it replaced with a new Versacross connect. Then went back up and continued the procedure as normal, procedure was completed with no patient consequences observed. The Activated Clotting Time (ACT) resulted 215 and it was given 10,000 more units of heparin. The irrigation flow was not interrupted during procedure. It was then pulled everything back and flushed everything out. Irrigation flow rate is unknown. TEE was used to rule out thrombus before the procedure. It is unknown if procedure performed was interrupt on anticoagulation regime. Time passed between initial ACT and last ACT recorded is unknown. Following ACT was greater than 400. No fibrin or coagulant was seen at the tip of the catheter. Anticoagulation status

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50936654 ↗
• InjuryAug 18, 2026Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  It was reported that during a Left Atrial Appendage Closure procedure, a VersaCross was selected for use. The physician obtained groin access and performed a transseptal puncture with the VersaCross Connect as normal. The Trusteer was advanced to the left side of the heart and exchanged for a pigtail wire to take a contrast shot. While attempting to advance the sheath, the physician noted difficulty and resistance. Fluoroscopy was performed, revealing a kinked sheath. At that point, a new Trusteer was opened, and no effusion was observed. To exchange, the VersaCross pigtail wire was re-advanced to the left side to maintain the same transseptal puncture. The second Trusteer was advanced smoothly to the left side without resistance. However, an effusion was then noted, and the physicians prepared for a pericardiocentesis. A cardiac tamponade also occurred. Approximately 200cc of fluid was drained, protamine was administered and the effusion stabilized. The physician believed the effusion occurred while exchanging. Due to the effusion, the decision was made not to proceed with Watchman implantation. It was also reported that resistance was encountered when attempting to advance the Tr

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50306522 ↗
• MalfunctionJul 16, 2026Nonstandard Device

  IT WAS REPORTED THAT VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR USE. IT WAS MENTIONED THAT WHEN THE DEVICE WAS PREPARED WITH THE DOUBLE CURVE SHEATH, THE SHEATH AND DILATOR TIP WAS NOTED DAMAGED. THUS THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS EXPECTED TO BE RETURN FOR ANALYSIS. IT WAS FURTHER CONFIRMED THAT DILATOR WAS NOT LOADED ON THE WIRE. THE DEVICE NEVER WENT INTO THE BODY, IT WAS NOTED DURING PREPARATION. THE CONNECT DILATOR WAS THE DBL CURVE WAS COMING APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25850282 ↗
• InjuryJun 17, 2026Positioning Failure; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE FOR AN ATRIAL FIBRILLATION CASE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. WHEN THE PHYSICIAN WAS GOING TRANSSEPTAL, HE WAS HAVING DIFFICULTY GETTING ACCESS TO THE SUPERIOR VENA CAVA (SVC) DUE TO LEADS OF A PACEMAKER THAT WERE COMING DOWN FROM THE SVC ONE LEAD WAS IN THE RIGHT ATRIUM, AND THE OTHER LEAD WAS IN THE RIGHT VENTRICLE. HE WAS HAVING ISSUES POSITIONING THE VERSACROSS TRANSSEPTAL SYSTEM ON THE FOSSA, DIFFICULTY HAVING A TENT ON THE FOSSA OVALIS. WHEN TENTING OF THE FOSSA WAS FINALLY ACQUIRED, IT WAS NOTICED TO BE AN INTERIOR POSITION ON THE THIN PORTION OF THE FOSSA, SO PHYSICIAN DECIDED TO TAKE IT AND DELIVER RADIO FREQUENCY ENERGY TO GO TRANSSEPTAL. THE VERSACROSS RF WIRE WAS ADVANCED FORWARD, BUT COULD NOT APPRECIATE IT ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). PHYSICIAN DECIDED TO PULL THE SYSTEM BACK INTO THE RIGHT ATRIUM (RA) AND TRY TRANSSEPTAL ONE MORE TIME. AFTER SEVERAL ATTEMPTS ON GOING TRANSSEPTAL AGAIN, PHYSICIAN LANDED ON THE FOSSA ON AN ANTERIOR POSITION AGAIN AND DECIDED TO DELIVER RF ENERGY ONE MORE TIME AND ADVANCED THE VERSACROSS RF WIRE ONE MORE TIME AND NOTICE THAT HE CO

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation of Vessels

  MAUDE report 25535463 ↗
• MalfunctionMay 6, 2026Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT VERSACROSS CONNECT FOR LAAC WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT WIRE WAS PUT UP THE SUPERIOR VENA CAVA AND DURING AN ATTEMPT TO BACKLOAD THE DILATOR OVER THE WIRE, THE WIRE HAD AN INSULATION BREAK THAT WOULD NOT LET THE DILATOR ADVANCE UP THE WIRE. THE PROCEDURE WAS COMPLETED USING DIFFERENT DEVICE (SAME WIRE). NO PATIENT COMPLICATIONS OCCURRED. THE PRODUCT IS NOT EXPECTED TO RETURN AS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093984 ↗
• DeathApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AORTIC ROOT PERFORATION, PERICARDIAL EFFUSION (PE) AND CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS CANCELLED. A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS BEING PERFORMED. A VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR USE. THERE WAS NO EFFUSION NOTED DURING PRE IMAGING. DUE TO CHALLENGING ANATOMY, TORTUROUS VESSELS AND A DILATED RIGHT ATRIUM, THE PHYSICIAN UTILIZED MULTIPLE TRANSEPTAL DEVICES TO ATTEMPT TO GAIN ACCESS. PHYSICIAN ATTEMPTED TRANSSEPTAL PUNCTURE USING VERSACROSS CONNECT LAAC, VERSACROSS ACCESS SOLUTION AND NRG TRANSSEPTAL NEEDLE. WHEN THE PHYSICIAN WAS ATTEMPTING TO CROSS WITH THE NRG, PATIENT BLOOD PRESSURE DROPPED. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING WAS UTILIZED TO EVALUATE FOR EFFUSION. IT WAS IMMEDIATELY NOTED FLUID COMPRESSING THE LEFT ATRIUM. ARTERIAL ACCESS WAS OBTAINED, FLOUROSCOPY IMAGING WAS PREFORMED WHICH REVEALED A PERFORATION IN THE AORTIC ROOT. THE PATIENT HAD PREVIOUS CORONARY ARTERY BYPASS GRAFTING (CABG), SO THIS WAS NOT A PERICARDIAL EFFUSION, IT WAS AN EFFUSION CAUSING EXTRINSIC COMPRESSION OF THE LEFT ATRIUM. THE EFFUSION WAS EVENTUALLY LARGE ENOUGH TO CAUSE COMPLETE CHAMBER COLLAPSE. THE HO

  Patient problems: Cardiac Tamponade; Hematoma; Low Blood Pressure/ Hypotension; Perforation of Vessels; Pericardial Effusion; Thrombosis/Thrombus

  MAUDE report 24901367 ↗
• InjuryMar 20, 2026Off-Label Use; Difficult to Advance

  IT WAS REPORTED THAT THE RADIOFREQUENCY (RF) WIRE WAS USED WITH AN INCOMPATIBLE SHEATH, THE WIRE HUNG UP A LITTLE WHEN CROSSING THE SEPTUM, AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE, HYPOTENSION, AND ATRIAL FIBRILLATION.DURING A PULSE FIELD ABLATION (PFA) PROCEDURE TO TREAT ATRIAL FIBRILLATION A VERSACROSS CONNECT RF WIRE WAS USED. IT WAS NOTED THAT THE RF WIRE HUNG UP A LITTLE WHEN CROSSING THE SEPTUM DURING THE TRANSSEPTAL PUNCTURE (TSP). THE NON-BOSTON SCIENTIFIC SHEATH CROSSED EASILY, THOUGH IT WAS A MODEL THAT IS INCOMPATIBLE WITH THE RF WIRE. IMAGES ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WERE POOR QUALITY, BUT THE LOCATION APPEARED TO BE A GOOD SPOT TO PERFORM THE TSP. WHEN THE PRE-MAP OF THE LEFT ATRIUM (LA) WAS PERFORMED THE PATIENT WAS HAVING HYPOTENSION WHEN IN ATRIAL FIBRILLATION. ICE WAS USED TO LOOK FOR AN EFFUSION, AND A SMALL ONE WAS NOTED. THE PATIENT WAS CARDIOVERTED AND THE PROCEDURE WAS CONTINUED. THE PHYSICIAN WANTED TO QUICKLY DO THE ABLATION, BUT AFTER DELIVERY OF ONE PULSE IT WAS DEEMED TO RISKY TO CONTINUE AND THE ABLATION PROCEDURE WAS CANCELLED. PERICARDIOCENTESIS WAS PERFORMED AND REMOVED 300ML OF BLOOD. THE PATIENT WAS ALSO ADMINISTERED PHARMACEUTICA

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

  MAUDE report 24651074 ↗
• MalfunctionFeb 26, 2026Difficult to Insert

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 17FEB2026. IT WAS REPORTED THAT DURING A LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. IT WAS NOTED DURING PREPARATION THAT WHEN IT WAS ATTEMPTED TO LOAD THE RF WIRE INTO THE DILATOR, IT WOULD NOT ADVANCE. MULTIPLE ATTEMPTS WERE MADE BY FLUSHING DILATOR AND TILTING, BUT IT WOULD NOT GO PAST THE EDGE. THUS, THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ISSUE OCCURRED PRIOR TO PATIENT BEING PRESENT. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. HOWEVER, ANALYSIS REVEALED A VERY MINOR FLARING AT PROXIMAL TRANSITION AND POLYTETRAFLUOROETHYLENE (PTFE) SHEARING OBSERVED MORE DISTAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454990 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use 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 LED TO SUBOPTIMAL

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Low Blood Pressure/ Hypotension; No Clinical Signs, Symptoms or Conditions; Pericardial Effusion

  MAUDE report 23480421 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERFORATION, PERICARDIAL EFFUSION (PE) AND CARDIAC TAMPONADE OCCURRED. DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. AFTER OBTAINING ACCESS, A INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER WAS INSERTED IN RIGHT GROIN. THE VERSACROSS CONNECT WAS INSERTED IN THE WATCHMAN TRUSTEER SHEATH AND PHYSICIAN BEGAN CLEARING APPENDAGE AND WAITING ON HEPARIN BEFORE GOING TRANSEPTAL. THE PHYSICIAN HAD ISSUES VISUALIZING WITH ICE AND EVENTUALLY GOT THE IMAGING TO GO TRANSEPTAL AND COMPLETED THE CASE. AFTER THE PROCEDURE WHILE EVALUATING FOR EFFUSION A NEW EFFUSION WAS OBSERVED WHICH WAS MONITORED FOR THIRTY MINUTES. IT DID NOT GROW IN SIZE, AND PATIENT WENT TO RECOVERY. SHORTLY AFTER THE PATIENT WAS BROUGHT BACK IN FOR PERICARDIOCENTESIS AFTER THEY WENT INTO TAMPONADE. DULL VENOUS BLOOD DURING TAP, 400ML REMOVED BEFORE THEY LEFT ROOM. ONCE PATIENT WAS STABLE AT THIS POINT AND RETURNED FOR OBSERVATION WITH A DRAIN IN PLACE. THE PHYSICIAN LATER NOTIFIED THAT THE PATIENT HAD JUST GOT OUT OF SURGERY, THEY HAD FOUND A PERFORATION IN THE SUPERIOR VENA CAVA (SVC) THAT WAS REPAIRED AND PATIENT IS EXPECTED TO RECOVER. THE PATIENT WAS HOSPITALIZED AFTER

  Patient problems: Cardiac Tamponade; Perforation; Pericardial Effusion

  MAUDE report 22785863 ↗
• InjuryAug 11, 2025Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. THE PHYSICIAN OBTAINED ACCESS USING A NON-BOSTON SCIENTIFIC 22 GAUGE NEEDLE, THEN INSERTED THE VERSACROSS WIRE INTO THE PATIENT. THE PHYSICIAN PARTIALLY RETRACTED THE WIRE, LIKELY SKIVING THE WIRE INSULATION. THE CASE WAS COMPLETED AS NORMAL. WHEN RETRACTING THE WATCHMAN SHEATH FROM THE LEFT ATRIUM (LA), AN UNUSUAL STRUCTURE WAS NOTICED IN THE LA. MULTIPLE IMAGES WERE TAKEN OF THE STRUCTURE. NO DAMAGE WAS NOTED ON ANY OF THE WATCHMAN EQUIPMENT, HOWEVER THERE WAS A NOTABLE DAMAGE TO THE VERSACROSS WIRE. IT IS LIKELY THAT THE WIRE WAS DAMAGED, THEN LOST A PIECE OF THE INSULATION WHEN IN THE LA. THE PLASTIC WAS SNARED BY THE PHYSICIAN, AND THE STRUCTURE DISAPPEARED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) HOWEVER, THERE WAS NO PLASTIC WAS FOUND IN THE SNARE, SO IT MAY HAVE MIGRATED SOMEWHERE ELSE IN THE BODY. THE STRAND WAS NO LONGER IN THE LEFT ATRIUM/HEART. THE PROCEDURE SUCCESSFULLY COMPLETED USING ORIGINAL METHOD AND/OR DEVICE AND NO PATIENT COMPLICATIONS OCCURRED. THE PATIENT WAS STABLE AND WAS DISCHARGED THAT AFTERNOON. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: Foreign Body In Patient

  MAUDE report 22774675 ↗
• InjuryMay 12, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) OCCURRED THAT LEAD TO CARDIAC TAMPONADE. THE PROCEDURE WAS CANCELLED. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS BEING PERFORMED, A VERSACROSS CONNECT LAAC KIT WAS SELECTED FOR USE. THERE WAS NO EFFUSION NOTED PRE PROCEDURE. THE PHYSICIAN OBTAINED ACCESS VIA THE RIGHT FEMORAL VEIN. THE WATCHMAN SHEATH AND VERSACROSS CONNECT SYSTEM WERE ADVANCED TO THE SUPERIOR VENA CAVE (SVC). DURING PULL DOWN FROM THE SVC TO THE INFERIOR VENA CAVA (IVC), THE POSITIONING FELL OFF THE SEPTUM AND THE PHYSICIAN PROCEEDED TO ADVANCE THE RF WIRE BACK UP TO THE SVC. THE PHYSICIAN STARTED TO PULL DOWN TO THE IVC AND THEN FELL INTO THE FOSSA. THE PHYSICIAN WAS TENTING INFERIOR AND ANTERIOR ON THE SEPTUM AND ENERGY WAS DELIVERED. BUBBLES WERE SEEN IN THE LEFT ATRIUM (LA) BUT THE WIRE DID NOT ADVANCE WITH EASE. THE PATIENT HAD A PRIOR ABLATION, AND THE PHYSICIAN BELIEVED IT WENT THROUGH THE IATROGENIC ATRIAL SEPTAL DEFECT (IASD). THE VERSACROSS WIRE WAS ADVANCE, AND THE DILATOR WAS REMOVED, AND A NON-BOSTON SCIENTIFIC PIGTAIL CATHETER ADVANCE TO LEFT ATRIAL APPENDAGE (LAA). AN LAA ANGIOGRAM WAS PERFORMED, AND THE WATCHMAN DELIVERY SYSTEM (WDS)

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

  MAUDE report 22005196 ↗
• MalfunctionMay 12, 2025Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR. IT WAS MENTIONED THAT THE DILATOR KEPT SHREDDING GUIDEWIRE. PROCEDURE COMPLETED USING AN ALTERNATE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURN (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004767 ↗