VersaCross™ Access Solution VXSK0134Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00685447019893), received between May 23, 2025 and Sep 18, 2026 — classified as 1 death, 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 10, 2025Open, Classified

   Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.

   Z-2103-2025 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient experience Pericardial effusion and perforation.VersaCross Connect Access Solution was selected for use. It was mentioned that once the transseptal was completed using versacross wire, the wire was sent into the left atrium. The Patient had thick septum, so was hard for the physician to push the sheath across. As per the physician opinion, Pericardial effusion occurred before ablation, when the physician pushed the Faradrive sheath too hard to cross, enabling the wire to puncture the LA. Perforation was noted in left atrium. Pericardiocentesis/TAP was performed and patient was transferred for Surgery into the OR (Operating Room). The Procedure was cancelled. Patient current status was unknown.

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

  MAUDE report 50817475 ↗
• InjuryJul 8, 2026Failure to Advance; Mechanics Altered

  It was reported that pericardial effusion occurred.A pulse field ablation procedure was performed for the treatment of atrial fibrillation using a Veracross Access solution and FARAWAVE catheter. Prior to transseptal system insertion, a pericardial effusion was documented. The patient was noted to have a persistent left superior vena cava (SVC), which made positioning and use of the VersaCross system and non-Boston Scientific transeptal needle challenging. Electrophysiologist (EP) noted a concern regarding the RF wire curve. During the procedure, the RF wire was advanced to perform transseptal crossing. Multiple attempts were required due to difficulty crossing the septum. A new VersaCross Access Solution kit was opened and used to successfully complete the transseptal puncture. Following completion of the transseptal puncture, an increase in pericardial effusion was observed approximately 60 minutes after access was obtained. Pericardiocentesis was performed, and approximately 600 mL of blood was drained using an effusion management kit. The patient was stabilized and the procedure was completed, including successful isolation of the pulmonary veins and posterior wall. The patient

  Patient problems: Pericardial Effusion

  MAUDE report 25756488 ↗
• DeathJul 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION A RF WIRE WAS SELECTED FOR USE. DURING PROCEDURE, A SERIES OF ATTEMPTS TO CROSS THE ATRIAL SEPTUM WERE COMPLETED. AFTER A NUMBER OF ATTEMPTS IT APPEARED THAT THE TIP OF THE SHEATH/WIRE HAD ADVANCED, AFTER INVESTIGATING WHERE THE WIRE WENT, IT APPEARED THAT THE WIRE WAS LOCATED IN THE PATIENT'S PERICARDIUM, THE WIRE WAS REMOVED AND LEFT IN THE IVC WHILE PATIENT WAS MONITORED. AFTER PATIENT WAS DEEMED STABLE, PROCEDURE CONTINUED WITH SUBSEQUENT SUCCESSFUL TSP AND WATCHMAN PROCEDURE. POST WATCHMAN A PERICARDIAL EFFUSION WAS NOTED, AND A DRAIN WAS PLACED. CARDIOLOGIST AND CT SURGEON WERE PRESENT TO EVALUATE PATIENT AND AGREED ON A CARE PLAN. IN THE NIGHT FOLLOWING PROCEDURE THE PATIENT HAD A SERIES OF COMPLICATIONS INCLUDING A STROKE, THAT EVENTUALLY ENDED IN THE PATIENT'S DEATH.

  Patient problems: Pericardial Effusion; Pleural Effusion; Stroke/CVA

  MAUDE report 25713970 ↗
• InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS MENTION THAT PERICARDIAL EFFUSION WAS NOTED AND THE PROCEDURE WAS CANCELLED. IT WAS MENTIONED THAT VERSACROSS ACCESS SOLUTION WAS SELECTED FOR ATRIAL FIBRILLATION (A FIB). IT WAS MENTIONED THAT DURING THE PROCEDURE ONCE THE PATIENT WAS SEDATED, RF AND WATCHMAN WAS IMPLANTED USING PHILIPS 4D ICE AND FLUOROSCOPY. ULTRASOUND GUIDED VENOUS ACCESS 3 WAS OBTAINED WITHOUT DIFFICULTY. INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING CONFIRMED THE LEFT ATRIAL APPENDAGE (LAA) WAS FREE OF CLOTS. A BASELINE PERICARDIAL EFFUSION OF 0.7 CM WAS NOTED ON CIRCUMFERENTIAL BUT MOSTLY ON RV SIDE. HALF DOSE HEPARIN WAS ADMINISTERED. TRANSEPTAL PUNCTURE WAS PERFORMED. THE VERSACROSS DEVICE WAS EASILY VISUALIZED, AND THE TRANSSEPTAL PUNCTURE WAS INFERIOR/POSTERIOR. WIRE AND SHEATH CROSSED WITHOUT ISSUE. CARTO MAPPING INDICATED THE PATIENT HAD A VERY SMALL LEFT ATRIUM. DURING ONGOING ICE MONITORING, THE PREVIOUSLY NOTED EFFUSION APPEARED LARGER. REPEAT MEASUREMENT SHOWED AN INCREASE TO 1.14 CM. HEPARIN WAS REVERSED WITH PROTAMINE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. A SECOND PHYSICIAN WAS CONSULTED FOR ADDITIONAL ASSESSMENT. BOTH PHYSICIANS AGREED THAT PERICARDIOCENTESIS WAS NOT NEED

  Patient problems: Pericardial Effusion

  MAUDE report 25631191 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CARDIAC TAMPONADE, TACHYCARDIA, HYPOTENSION, INTERMITTENT CHEST PAIN, AND NAUSEA. AFTER A CONCOMITANT PULSE FIELD ABLATION (PFA) AND LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE A VERSACROSS RF WIRE WAS USED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS MOVED TO HOLDING FOR RECOVERY, BUT ABOUT TWO HOURS LATER THE PATIENT BECAME TACHYCARDIC, HYPOTENSIVE, AND PALE WITH NAUSEA AND INTERMITTENT CHEST PAIN. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED, AND A LARGE EFFUSION WAS FOUND. THE PATIENT WAS BROUGHT TO THE LAB FOR EMERGENT PERICARDIOCENTESIS AND DRAIN PLACEMENT WHICH REMOVED 1L OF DARK RED BLOOD FROM THE PERICARDIAL SPACE. THE PATIENT WAS ADMITTED TO THE CARDIOVASCULAR INTENSIVE CARE UNITED (CVICU) FOR ADDITIONAL MONITORING. THE PATIENT IS EXPECTED TO FULLY RECOVER.

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

  MAUDE report 24637874 ↗
• InjuryMar 12, 2026Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A FARAPULSE PROCEDURE TO TREAT PAROXYSMAL ATRIAL FIBRILLATION (A FIB), A VERSACROSS ACCESS SOLUTIONS KIT, NON-BOSTON SCIENTIFIC DIAGNOSTIC CATHETER, AND FARAWAVE CATHETER WERE SELECTED FOR USE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN UTILIZED INTRACARDIAC ECHOCARDIOGRAPHY (ICE) TO SEE THE PRESENCE OF A TRACE PERICARDIAL EFFUSION PRIOR TO PERFORMING THE TRANSSEPTAL PUNCTURE (TSP). THE PHYSICIAN THEN PERFORMED AN ICE GUIDED TSP WITH A VERSACROSS ACCESS SOLUTIONS KIT. NO CHANGE IN EFFUSION NOTED. THE HEART WAS MAPPED WITH A NON-BOSTON SCIENTIFIC DIAGNOSTIC CATHETER, AND THE PHYSICIAN NOTED LEFT SUPERIOR PULMONARY VEIN (LSPV) AND LEFT ATRIAL APPENDAGE (LAA) WERE EXTREMELY CLOSE. AS SOON AS THE NON-BOSTON SCIENTIFIC DIAGNOSTIC CATHETER WAS REMOVED, PRIOR TO FARAWAVE INSERTION, THE PHYSICIAN SCANNED FOR AN EFFUSION CHECK WITH ICE. THE PHYSICIAN NOTED A GREATER THAN 2CM EFFUSION, AND INSTRUCTED STAFF TO PREP FOR PERICARDIOCENTESIS. MORE THAN 1000ML OF FLUID WAS REMOVED. AT THAT TIME, A CARDIOTHORACIC (CT) SURGEON WAS CALLED, AND THE PATIENT WAS BROUGHT TO THE OPERATING ROOM (OR) FOR FURTHER SURGICAL INTERVENTION. THE FARAPULSE PROCEDURE WAS CAN

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 24578610 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LAA THROMBOSIS OCCURRED, WHICH LED TO THE CANCELLATION OF THE PROCEDURE. IT WAS REPORTED THAT A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION. AFTER COMPLETING THE TRANSSEPTAL PUNCTURE, LEFT ATRIAL ICE IMAGING IDENTIFIED A THROMBUS IN THE LEFT ATRIUM APPENDAGE, AND THE PROCEDURE WAS SUBSEQUENTLY CANCELED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY. NO MALFUNCTION WITH THE DEVICE WAS REPORTED. NO FURTHER INFORMATION WAS REPORTED. THE PRODUCT IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS, AS IT WAS DISPOSED OF AT THE FACILITY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24241553 ↗
• MalfunctionNov 4, 2025Mechanical Problem; Off-Label Use; Air/Gas in Device; Mechanical Problem; Off-Label Use; Air/Gas in Device

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT ATRIAL FIBRILLATION FARADRIVE STEERABLE SHEATH AND VERSACROSS ACCESS SOLUTION WERE SELECTED FOR USE. IT HAS BEEN MENTIONED THAT THE SHEATH WAS FAULTY RESULTING IN SIGNIFICANT BLEED BACK FROM THE VALVE OF THE SHEATH AND EXCESSIVE AIR BUBBLES IN THE SHEATH SHAFT AFTER TRANSSEPTAL. VERSACROSS ACCESS SOLUTION HAD BEEN INSIDE THE SHEATH PRIOR TO, AND/OR AT THE TIME, THE AIR WAS OBSERVED. PUMP WAS USED FOR IRRIGATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE (SAME MODEL). NO AIR WAS SEEN IN THE PATIENT. NO PATIENT COMPLICATIONS OCCURRED. THE PRODUCT IS NOT EXPECTED TO RETURN AS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465368 ↗
• MalfunctionAug 18, 2025Device-Device Incompatibility; Difficult to Advance; Material Deformation; Material Integrity Problem; Device-Device Incompatibility; Difficult to Advance; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT VERSACROSS ACCESS SOLUTION SELECTED FOR ABLATION PROCEDURE. RF WIRE GOT KINKED DURING NAVIGATION INTO SUPERIOR VENA CAVA (SVC). IT WAS FORCED THE RF WIRE BACK INTO DILATOR, BUT THE WIRE CAUGHT THE COATING IN THE INNER LUMEN OF THE DILATOR. THE KINK WAS OBSERVED AFTER THE WIRE REMOVED FROM THE BODY WHICH STOP FURTHER ADVANCEMENT OF THE DILATOR. THERE WAS NO VISIBLE DAMAGE IN THE VERSACROSS RF WIRE BUT AFTER REMOVAL THE WIRE APPEARED KINKED AND INSULATION WAS STRIPPED AT THE DISTAL END. HENCE, THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS NOT EXPECTED TO RETURN FOR ANALYSIS (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22832524 ↗
• MalfunctionJun 5, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE DURING A PULMONARY VEIN ISOLATION. ONCE THE DEVICE PACKAGED WAS OPENED, IT WAS NOTED THE VERSACROSS RF WIRE WAS FRAYING. HENCE, THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22151831 ↗
• MalfunctionMay 23, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. AFTER USING THE PIGTAIL RADIO FREQUENCY (RF) WIRE AS A STARTER WIRE, IT WAS NOTICED THAT THE COATING ON THE TIP WAS PEELING OFF. THUS, A NEW ONE WAS OPENED TO GO TRANSSEPTAL AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078636 ↗