VersaCross™ Access Solution VXSK0101Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00685447019749), received between Feb 11, 2026 and Mar 30, 2026 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Material Integrity Problem

  IT WAS REPORTED THAT A VERSACROSS ACCESS SOLUTIONS KIT WAS SELECTED TO BE USED IN A PROCEDURE TO TREAT ATRIAL FIBRILLATION. JUST PRIOR TO INSERTION OF THE RF WIRE INTO THE PATIENT, AFTER THE WIRE HAD BEEN INSERTED INTO A SHORT SHEATH FOR SHEATH EXCHANGE, THE COATING WAS OBSERVED TO BE PEELING OFF THE DISTAL TIP. NO OTHER DAMAGE WAS NOTED TO ANY ACCESSORY DEVICES THAT COULD HAVE CONTRIBUTED TO THE COATING ISSUE. THE KIT WAS REPLACED WITH A SIMILAR KIT, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE KIT WAS DISPOSED AND IS NOT EXPECTED TO RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24720065 ↗
• InjuryFeb 11, 2026Difficult to Advance

  IT WAS REPORTED THAT A THROMBOSIS AND PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. THE PHYSICIAN WAS ATTEMPTING TO CROSS SEPTUM BUT WAS UNSUCCESSFUL THE FIRST FEW TIMES APPLYING ENERGY WITH ONE SECOND CONSTANT GENERATOR SETTING. ON THE FOURTH ATTEMPT, THE WIRE ADVANCED INTO THE LEFT ATRIUM (LA). THE PHYSICIAN FELT THAT THE WIRE CROSSED INTO THE LA THEN INTO PERICARDIUM. A PERICARDIAL EFFUSION (PE) WAS NOTED. THE IMPLANTER AND PHYSICIAN IMMEDIATELY SHIFTED TO OPENING A PERICARDIOCENTESIS TRAY AND TAPPING THE PATIENT. THE PATIENT WAS SENT TO SURGERY FOR WINDOW AND CLOT ASPIRATION. THE PATIENT WAS HOSPITALIZED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). IT WAS FURTHER REPORTED THAT THE SEPTUM WAS ANEURYSMAL. PATIENT WAS SENT TO SURGERY AFTER STABILIZED TO CREATE A WINDOW TO REMOVE SOME RESIDUAL CLOT IN THE PERICARDIUM. NO MALFUNCTIONS OR CONTRIBUTIONS FROM VERSACROSS. THE PATIENT WAS LATER DISCHARGED.

  Patient problems: Pericardial Effusion; Thrombosis/Thrombus

  MAUDE report 24316708 ↗