VersaCross Access Solution VXSK0024 (REF NA)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00685447011750), received between Mar 20, 2024 and Jun 24, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2024Material Frayed; Material Frayed

  IT HAS BEEN REPORTED THAT A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR AN ATRIAL FIBRILLATION (A FIB) ABLATION PROCEDURE. DURING THE PROCEDURE, AS THE PHYSICIAN WAS ATTEMPTING TO GET ACCESS WITH VERSACROSS RF WIRE, HE WAS EXPERIENCING DIFFICULTY INSERTING THE VERSACROSS SHEATH INTO THE PATIENT'S RIGHT FEMORAL VEIN. THEREFORE, THE PHYSICIAN REMOVED THE VERSACROSS RF WIRE AND NOTICED THAT PART OF THE DEVICE WAS FRAYING AT ITS DISTAL END. THE RF WIRE WAS INSERTED THROUGH A NON-BOSTON SCIENTIFIC INTRODUCER NEEDLE PRIOR TO THE ISSUE BEING NOTED. THE RF WIRE WAS THEN REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19600686 ↗
• MalfunctionApr 15, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. IT WAS NOTED THAT THE DEVICE WAS NOT ABLE TO GO TRANSSEPTAL. NO FURTHER DETAILS WERE PROVIDED. THE PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105400 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED. DURING AN ATRIAL FIBRILLATION (A FIB) PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. A PERICARDIAL EFFUSION (PE) WAS NOTED WHEN THE TRANSSEPTAL PUNCTURE (TSP) WAS BEING PERFORMED USING VERSACROSS SHEATH AND RADIO FREQUENCY WIRE. THE PE WAS CONFIRMED USING AN ULTRASOUND SCAN WITH A NON-BOSTON SCIENTIFIC CATHETER. HENCE, THE ABLATION WAS NOT COMPLETED. THE PATIENT BLOOD PRESSURE WAS DROPPED. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS STABILIZED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. EVENT REPORTED VIA MEDWATCH MDR REPORT # MW5151066.

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

  MAUDE report 18941532 ↗