VersaCross Steerable Access Solution VSTK0018Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00685447012092), received between Jun 7, 2023 and Apr 2, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 2, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (A FIB) ABLATION PROCEDURE, A VERSACROSS STEERABLE ACCESS SOLUTION KIT WAS SELECTED FOR USE. UPON DEVICE REMOVAL FROM ITS PACKAGING TRAY, IT WAS NOTED THAT THE SHEATH WAS CONTAMINATED. HENCE, THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISCARDED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19022043 ↗
• MalfunctionJun 7, 2023Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED DURING AN ATRIAL FIBRILLATION (A FIB) ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB), A VERSACROSS STEERABLE ACCESS SOLUTION KIT WAS SELECTED FOR USE. VENOUS FEMORAL ACCESS WAS GAINED USING THE STANDARD J-TIP 035 GUIDEWIRE, THEN VERSACROSS SHEATH WAS ADVANCED. THE GUIDEWIRE WAS REMOVED AND VERSACROSS RADIO FREQUENCY WIRE WAS ADVANCED. THE RADIO FREQUENCY WAS APPLIED ONCE AND WAS UNSUCCESSFUL AT CROSSING THE FOSSA. SECOND ATTEMPT WAS MADE AND WAS SUCCESSFUL CROSSING THE FOSSA. THEN THE RADIO FREQUENCY WIRE WAS ADVANCED INTO THE LEFT SUPERIOR PULMONARY VEIN (LSPV) AND ADVANCED THE DILATOR AND SHEATH ACROSS THE FOSSA. HOWEVER, AS THE DILATOR AND RADIO FREQUENCY WIRE WAS BEING REMOVED, THE RADIO FREQUENCY WIRE COULD NOT BE RETRACTED. ON FLUORO, IT WAS NOTICED THE WIRE WAS TIED INTO A KNOT. IT WAS REPORTED THAT THERE WERE NO DEFECTS IN THE WIRE, NO UNUSUAL ANATOMY, NO DIFFICULTY LOADING THE RF WIRE. IT IS UNKNOWN IF THE DILATOR WAS SHAPED BEFOREHAND. BOTH ATTEMPTS TO CROSS WERE 1 SECOND CONSTANT PULSE, AND THE KNOT FORMED AFTER GETTING ACCESS IN THE LEFT ATRIUM SO THE KNOT FORMED IN THE LEFT ATRIUM. TO RESOLVE, THE DILATOR WAS ADVANCED BACK AS FAR AS IT COULD GO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083246 ↗