VersaCross Steerable Access Solution VSTK0016 (REF NA)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00685447007135), received between Jan 28, 2025 and Apr 14, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2025Material Perforation; Material Perforation

  IT WAS REPORTED THAT DURING A PULSE FIELD ABLATION PROCEDURE, A VERSACROSS STEERABLE ACCESS SOLUTION WAS SELECTED FOR USE. THE PHYSICIAN PERFORMED TRANSSEPTAL PUNCTURE SUCCESSFULLY AND UPON THE DEVICE REMOVAL, IT WAS NOTED THAT THE SHEATH TIP WAS DAMAGED. THERE WAS A TEAR NOTED IN THE PRODUCT. THE PHYSICIAN COMPLETED THE PROCEDURE, AND NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21836720 ↗
• MalfunctionJan 28, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT VERSACROSS STEERABLE ACCESS SOLUTION WAS SELECTED FOR PULMONARY VEIN ISOLATION PROCEDURE. DURING THE PROCEDURE, WHEN VERSACROSS RF WIRE WAS INTRODUCED INTO THE PATIENT BODY FROM THE TRANSSEPTAL SHEATH, AND THE OUTER COATING OF THE TRANSSEPTAL WIRE CAME OUT FROM RIGHT SIDE OF THE MARKER BAND. THUS, THE VERSACROSS RF WIRE WAS REPLACED AND NEW TRANSSEPTAL WIRE WAS USED FORM THE DIFFERENT VERSACROSS KIT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURN FOR ANALYSIS. THE DEVICE WAS INTACT AND WAS REMOVED WITHOUT ANY FURTHER COMPROMISE. ITS INSULATION STRIPPED OFF AT ITS PROXIMAL END. THE ISSUE WAS NOTED WHEN THE PHYSICIAN WAS INITIALLY FINDING THE MARKER BAND FOR REFERENCE TO MOVE TO THE GROIN ACCESS SITE, A SMALL TAB ATTACHED FROM THE PROXIMAL END WAS NOTED. THE DISTAL TIP WAS NOT TO THE HEART WHEN THIS WAS DISCOVERED AND THE DE-INSULATED PART NEVER WENT INTO ANY OTHER DEVICE, ONLY CAME OUT OF THE HOOP. THE RF WIRE WAS INSERTED INTO A HEMOSTATIC VALVE ON A SHORT SHEATH. THE PRODUCT WAS RECEIVED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21256488 ↗