VersaCross Large Access Solution VLAK0010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00685447017530), received between Dec 11, 2024 and Dec 11, 2024 — classified as 1 malfunction.

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

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2024Difficult to Advance; Material Deformation; Physical Resistance/Sticking; Difficult to Advance; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT VERSACROSS LARGE ACCESS SOLUTION WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS MENTIONED THAT WHEN THE BMC RF GENERATOR WAS TURNED ON AND ATTEMPT WERE MADE FOR TRANSSEPTAL, BUT IT FAILED. IT CROSSED IN THE SECOND ATTEMPT AND THE SHEATH WAS ADVANCED. WHEN THE PHYSICIAN TRIED TO PULL BACK THE VERSACROSS RF WIRE INTO THE DILATOR, IT FELT IT GOT STUCK INTO THE DILATOR (BUT NOT INTO THE PATIENT BODY), SO THE VERSACROSS RF WIRE WAS READVANCED INTO THE DILATOR. NO VISIBLE OBSTRUCTION WAS NOTED WHEN THE VERSACROSS RF WIRE WHEN VISUALIZED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IN LEFT SUPERIOR PULMONARY VEIN (LSPV). THE PHYSICIAN APPLIED FORCE BACK TO THE DILATOR, AND THE VERSACROSS RF WIRE WAS NOTED TO BE KNOTTED AT ITS TIP. THUS, THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURN FOR ANALYSIS. NO OTHER ISSUE WAS REPORTED DURING TRANSSEPTAL PORTION NOR PREPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901963 ↗