VersaCross™ Access Solution VXSK0124Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00685447019848), received between Jul 11, 2025 and Jul 27, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  During an atrial fibrillation procedure, a VXSK (180P RF Wire, 63cm/55deg/D1) was selected. During the procedure, after the physician got access, he put a non-Boston Scientific ICE catheter in and then he placed the Cosronary Sinus (CS) catheter in the CS. When physician positioned his ICE catheter for transseptal it was noted that the patient had a very thick superior as well as inferior limbus, and that the fossa was very small for crossing into the Left Atrium (LA). He then advanced the VersaCross fixed sheath with RF wire and got that positioned the fossa for transseptal. Once he confirmed that he had maximal tenting in a safe location that was not too anterior nor too posterior, RF was delivered then the wire was confirmed in the left atrium via visualization with the ICE catheter and images were stored. The wire was advanced into the left inferior pulmonary vein (LIPV), which was confirmed on ICE as well as the use of the non-Boston Scientific mapping system, the mapper commented that the wire was taking a posterior trajectory. The physician "flossed" the septum by advancing the VersaCross sheath and dilator over the wire at the septum multiple times. Then he pulled the sheat

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

  MAUDE report 50038626 ↗
• InjuryJun 29, 2026Off-Label Use; Device Sensing Problem

  A FARAWAVE NAV CATHETER AND VERSACROSS ACCESS SOLUTION WERE SELECTED FOR A PULMONARY VEIN ISOLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION. VASCULAR ACCESS WAS OBTAINED AND A TRANSSEPTAL PUNCTURE WAS ATTEMPTED USING A VERSACROSS DEVICE ADVANCED THROUGH A NON-BOSTON SCIENTIFIC (NON-BSC) 13F SHEATH. THE PHYSICIAN INITIALLY EXPERIENCED DIFFICULTY VISUALIZING THE INTERATRIAL SEPTUM WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE), AND DESPITE APPROXIMATELY ONE HOUR OF ATTEMPTS, ADEQUATE VISUALIZATION AND DEVICE TENTING COULD NOT BE CONFIRMED. NO ISSUES WERE OBSERVED WITH THE VERSACROSS RF WIRE OR ANY BOSTON SCIENTIFIC DEVICE. IT REMAINS UNKNOWN WHETHER PATIENT-SPECIFIC ANATOMY CONTRIBUTED TO THE INABILITY TO VISUALIZE THE SEPTUM. THE TEAM SUBSEQUENTLY TRANSITIONED TO TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) GUIDANCE, AND TRANSSEPTAL ACCESS WAS SUCCESSFULLY OBTAINED. IT WAS NOTED THAT THE PUNCTURE LOCATION MAY HAVE BEEN SLIGHTLY ANTERIOR. FOLLOWING LEFT ATRIAL ACCESS, MAPPING WAS PERFORMED USING A NON-BSC MAPPING CATHETER, AND PULMONARY VEIN ISOLATION WAS INITIATED WITH THE FARAWAVE NAV CATHETER. DURING THE FIRST ABLATION APPLICATION IN THE LEFT SUPERIOR PULMONARY VEIN, THE PATIENT EXPERIENCED A

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

  MAUDE report 25654109 ↗
• MalfunctionApr 20, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A PULMONARY VEIN ISOLATION, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT SHEATH VALVE WAS LEAKING BACK AFTER DILATOR REMOVED AND WITH MAPPING CATHETER IN SHEATH. IT WAS ATTEMPTED REMOVING MAPPING CATHETER AND PUTTING IT BACK IN. THUS, THE PHYSICIAN DECIDED TO USE SHEATH WITH HIGH DRIP RATE. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933159 ↗
• MalfunctionAug 11, 2025Device Dislodged or Dislocated; Material Integrity Problem; Device Dislodged or Dislocated; Material Integrity Problem

  IT WAS REPORTED THAT VERSACROSS ACCESS SOLUTION SELECTED FOR ATRIAL FLUTTER (AF) ABLATION PROCEDURE. DURING THE PROCEDURE, ONCE TRANSSEPTAL ACCESS WAS BEING ATTEMPTED IN THE LEFT ATRIUM, PHYSICIAN REMOVED THE VERSACROSS SHEATH AND DILATOR LEAVING THE VERSACROSS RF WIRE IN PLACE IN THE LEFT SUPERIOR PULMONARY VEIN (LSPV). WHEN TRYING TO BACKLOAD THE WIRE INTO THE FARADRIVE SHEATH AND DILATOR FOR A SHEATH EXCHANGE INTO THE LEFT ATRIUM (LA), IT WAS NOTED THAT THE COATING ON THE RF WIRE WAS PREVENTING BACKLOADING OF THE WIRE INTO THE SHEATH AND DILATOR. MULTIPLE ATTEMPTS WERE MADE TO BACKLOAD THE WIRE, BUT THE COATING SEEMED TO PEEL BACK AND CREATE MORE OF A HURDLE TO BACKLOADING THE WIRE IN. IN AN ATTEMPT TO SAVE THE TSP PUNCTURE, THE PHYSICIAN ATTEMPTED TO BACKLOAD THE VERSACROSS SHEATH BACK ONTO THE RF WIRE INSTEAD. UNFORTUNATELY, THEY COULD NO LONGER BACKLOAD THE RF WIRE INTO THE VERSACROSS SHEATH EITHER. TRANSSEPTAL ACCESS WAS LOST. HENCE, THE DEVICE WAS REPLACED AND THEN ABLE TO GET TRANSSEPTAL ACCESS AGAIN AND WAS THEN ABLE TO EASILY BACKLOAD THE FARADRIVE ONTO THE NEW RF WIRE FROM THE NEW VERSACROSS SHEATH AND RF WIRE KIT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22777186 ↗
• MalfunctionJul 11, 2025Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT VERSACROSS ACCESS SOLUTION WAS SELECTED FOR ATRIAL FIBRILLATION (A FIB). DURING THE PROCEDURE, IT WAS MENTIONED THEY TRIED TO USE THE RF WIRE WITH THE VIZIGO SHEATH FOR TRANSSEPTAL PUNCTURE, WHICH WAS NOT INTENDED TO USE. AS A RESULT, THE COATING AROUND THE WIRE STRIPPED OFF. THUS THE RF WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATION WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22481192 ↗