VersaCross™ Access Solution VXSK0131Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00685447019862), received between Oct 22, 2025 and Aug 10, 2026 — classified as 2 deaths, 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (2 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50197014 ↗
• InjuryAug 7, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem

  It was reported that pericardial effusion, hypotension and tachycardia occurred.A pulmonary vein isolation (PVI) procedure utilizing pulse field ablation (PFA) was planned for the treatment of paroxysmal atrial fibrillation. A VersaCross Access Solution was selected for transseptal access. During the procedure, the physician performed transseptal puncture using the VersaCross RF wire through a non-Boston Scientific (non-BSC) sheath. RF energy was delivered via a Baylis generator, and the non-BSC sheath was advanced over the wire. No resistance was encountered while advancing or maneuvering any catheters or devices, and no issue was noted during the transseptal access. Following successful transseptal access, the VersaCross RF wire was removed. During left atrial mapping with a non-BSC Mapping Catheter and prior to delivery of any ablation lesions, the patient became hemodynamically unstable, with a decrease in blood pressure and an increase in heart rate. Evaluation identified a pericardial effusion. The physician withdrew the equipment into the right atrium and performed pericardiocentesis with placement of a pigtail drain. The effusion was treated before progression to cardiac ta

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

  MAUDE report 50175687 ↗
• MalfunctionJul 6, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT VERSACROSS ACCESS SOLUTION WAS SELECTED FOR ATRIAL FIBRILLATION (A FIB) PULMONARY VEIN ISOLATION PROCEDURE. DURING INSERTION, VERSACROSS DEVICE GOT STUCK ON WIRE WHEN INSERTED FEW INCHES INTO THE PATIENT'S BODY. IT WAS UNSAFE TO USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING DIFFERENT DEVICE, SAME MODEL. NO PATIENT COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25721916 ↗
• DeathJun 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEATH HAS OCCURRED. DURING FLX PRO PROCEDURE VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. TENTING WAS DONE ON THE SEPTUM INFERIORLY AND POSTERIORLY AND THE VERSACROSS CROSSED WITHOUT ANY RF BEING APPLIED. VERSACROSS PIGTAIL WIRE WENT INTO THE APPENDAGE. THE WIRE WAS PULLED BACK SUCCESSFULLY INTO THE VEIN TO BRING THE VERSACROSS FIXED SHEATH ACROSS. AT THIS TIME THE PHYSICIAN NOTICED A LARGE PERICARDIAL EFFUSION AND BLOOD PRESSURES WERE DROPPING. PERICARDIOCENTESIS TRAY WAS USED TO TAP THE PERICARDIAL SPACE AND CALLED A CODE. A FEW MINUTES LATER SURGICAL BACK UP WAS IN THE ROOM. CHEST COMPRESSIONS WERE DONE FOR ABOUT 45 MINUTES, AND BLOOD TRANSFUSION WAS DONE, BUT THE PATIENT'S BLOOD PRESSURE NEVER STABILIZED. THE OFFICIAL CAUSE OF DEATH WAS CARDIAC TAMPONADE. THE DEVICE IS NOT EXPECTED TO BE RETURNING AS IT HAS BEEN DISPOSED.

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

  MAUDE report 25627534 ↗
• MalfunctionMay 25, 2026Failure to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE USING A RF WIRE FOR TRANSSEPTAL PUNCTURE THE WIRE WAS UNABLE TO CROSS; NO ERRORS WERE OBSERVED ON THE GENERATOR DURING USE OF THE VERSACROSS WIRE, APPROXIMATELY 2 MM OF THE WIRE WAS EXPOSED OUTSIDE THE DILATOR PRIOR TO THE ATTEMPTED CROSSING, TWO CROSSING ATTEMPTS WERE MADE WITH RF APPLIED EACH TIME, AND NO DAMAGE WAS NOTED ON THE DISTAL END OF THE WIRE UPON REMOVAL FROM THE BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267603 ↗
• MalfunctionMay 7, 2026Material Perforation

  IT WAS REPORTED THAT DURING PREPARATION/ PRIOR TO PROCEDURE OF FLX PRO PROCEDURE, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. IT WAS NOTICED THAT THE TIP OF THE DILATOR WAS DAMAGED. THE ISSUE WAS NOTED BEFORE INSERTING INTO THE BODY WHERE THE TIP PIECE APPEARED FRAYED. THERE WERE NO PATIENT COMPLICATIONS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ALTERNATIVE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25118957 ↗
• InjuryMay 6, 2026Difficult to Advance

  IT WAS REPORTED THAT PERICARDIAL EFFUSION (PE) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED UNDER INTRACARDIAC ECHOCARDIOGRAPHY (ICE) GUIDANCE. BASELINE IMAGING DEMONSTRATED NO PE. THE INTERATRIAL SEPTUM WAS NOTED TO BE THICK, AND TRANSSEPTAL PUNCTURE (TSP) WAS PERFORMED WITH A VERSACROSS FIXED CURVE TRANSSEPTAL SYSTEM IN AN INFERIOR/MID LOCATION. DIFFICULTY WAS ENCOUNTERED ADVANCING THE VERSACROSS SYSTEM INTO THE LEFT ATRIUM, BUT ACCESS WAS EVENTUALLY ACHIEVED. ATTEMPTS WERE THEN MADE TO ADVANCE A WATCHMAN TRUSTEER ACCESS SYSTEM (WAS) ACROSS THE SEPTUM HOWEVER THE WAS WOULD NOT CROSS. A SECOND TSP WAS PERFORMED IN A SIMILAR LOCATION TO IMPROVE ACCESS. FOLLOWING THESE ATTEMPTS, A PE WAS IDENTIFIED NEAR THE RIGHT ATRIUM, ACCOMPANIED BY A MILD DECREASE IN BLOOD PRESSURE. THE PROCEDURE WAS ABORTED AND PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS ADMITTED OVERNIGHT.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 25094002 ↗
• DeathApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IIT 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 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 HOSPITAL INITI

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

  MAUDE report 24901359 ↗
• MalfunctionApr 14, 2026Nonstandard Device

  IT WAS REPORTED THAT PRIOR TO MITRAL CLIP PROCEDURE, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. IT WAS NOTED THE ONE END OF THE RF WIRE WAS TOO ROUGH AND 'CHEWED UP' TO BE USED. THERE WAS NO PACKAGING DAMAGE. THUS, THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24878753 ↗
• MalfunctionFeb 19, 2026Material Integrity Problem

  IT WAS REPORTED THAT VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. IT WAS MENTIONED THAT THE RF WIRE WAS NOTED SHREDDED DURING PREPARATION FOR THE PROCEDURE. THUS, THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURN FOR ANALYSIS AS IT WAS RETAINED BY CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389232 ↗
• InjuryFeb 2, 2026Device Sensing Problem

  THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. IT WAS REPORTED THAT A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE DURING A FARAPULSE ABLATION TO TREAT PERSISTENT ATRIAL FIBRILLATION. INITIALLY, THE PHYSICIAN GAINED VASCULAR ACCESS WITHOUT DIFFICULTY AND SUCCESSFULLY INSERTED A ICE CATHETER AND A NON-BOSTON SCIENTIFIC CORONARY SINUS CATHETER. HENCE, THE VERSACROSS DEVICES WERE INSERTED, WITH NO RESISTANCE AND POSITIONED ON THE SEPTUM. THE TRANSSEPTAL WAS THEN COMPLETED, HOWEVER THE PHYSICIAN WAS UNABLE TO VISUALIZE THE RF WIRE LOCATION AND THEREFORE RETRACTED IT BACK INTO THE RIGHT ATRIUM. THEN, A SECOND TRANSSEPTAL PUNCTURE WAS PERFORMED USING THE SAME SYSTEM, SUCCESSFULLY ADVANCING THE THE VERSACROSS DEVICES INTO THE LEFT ATRIUM, AND THE HAVE BEEN REPLACED BY THE FARADRIVE IN THE LEFT ATRIUM. THE VERSACROSS RF WIRE WAS REPLACED BY THE NON-BOSTON SCIENTIFIC MAPPING CATHETER. UPON COMPLETION OF THE PRE-MAPPING, THE CATHETER WAS THEN EXCHANGED FOR THE FARAWAVE CATHETER SUCCESSFULLY. APPROXIMATELY 5-7 MINUTES INTO ABLATION, THE ANESTHESIOLOGIST REPORTED A DROP IN BLOOD PRESSURE. USING THE ICE CATHETER, THE PHYSICIAN IDENTIFIED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS IMME

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 24240527 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBUS OCCURRED. PROCEDURE WAS ABORTED. IT WAS REPORTED THAT VERSACROSS CONNECT LAAC ACCESS SOLUTION SELECTED FOR USE. HEPARIN WAS ADMINISTRATED RIGHT BEFORE TRANSSEPTAL PUNCTURE. DURING PROCEDURE, INTRACARDIAC THROMBUS WAS DISCOVERED IN THE LEFT ATRIAL APPENDAGE AFTER THE CONTRAST SHOT WAS TAKEN. PIGTAIL CATHETER WAS IN THE APPENDAGE. PHYSICIAN WENT THROUGH THE PRE-IMAGING. THEY CLEARED FOR INTRA-ATRIAL THROMBUS. THERE WAS NO SPONTANEOUS ECHO CONTRAST OR ANYTHING THAT INDICATED A CLOT. THERE WAS NO INDEPENDENT MOVEMENT AND HAD VERY CLEAR IMAGING OF THE APPENDAGE IN 0,45,90, AND 135. THE PROCEDURE WENT NORMALLY. PHYSICIAN GAINED FEMORAL VEIN ACCESS AND USED THE VERSACROSS FIXED KIT TO GET LA ACCESS WITH A LOW-MID STICK. THE TRANSSEPTAL SHEATH WAS EXCHANGED FOR THE WATCHMAN TRUSTEER SHEATH. THE PIGTAIL CATHETER WAS LOADED OVER THE VERSACROSS WIRE AND INTO THE LEFT ATRIAL APPENDAGE. AROUND THIS TIME, WE GOT AN ACT OF 319. THE PIGTAIL WAS NAVIGATED INSIDE THE APPENDAGE, AND A CONTRAST SHOT WAS GIVEN. AFTER THE FLUORO, WE OPENED AND PREPARED THE 27MM WATCHMAN. AFTER WE FINISHED FLUSHING, THE DOCTORS MOVED TO SWAP THE PIGTAIL CATHETER OUT WITH THE DEVICE. PHYSICIA

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23359015 ↗