VersaCross™ Steerable Access Solution VSTK0115Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00685447019657), received between Nov 24, 2025 and Sep 18, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Fluid/Blood Leak

  It was reported that during a Pulsed Field Ablation (PFA) procedure for the treatment of atypical atrial flutter, a VersaCross Steerable Access Solution was selected for use. The dilator was inserted into the sheath without resistance, followed by advancement of the FARAPOINT catheter and ORION mapping catheter across the valve. No resistance was encountered during insertion of the ORION mapping catheter. During the procedure, the physician observed significant leakage from the sheath valve, described as a fast drip of saline during flushing. The syringe was securely attached to the handle luer, and no damage to the device or luer was noted. There was no air leakage or air observed in the patient, and no error messages were displayed. No RF generator was used. The procedure was successfully completed without troubleshooting. The patient remained stable, and no patient complications were reported as a result of the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819349 ↗
• MalfunctionApr 13, 2026Delivered as Unsterile Product; Unsealed Device Packaging

  IT WAS REPORTED THAT PRIOR TO AN ATRIAL FIBRILLATION PROCEDURE, PULSE FIELD ABLATION PROCEDURE A VERSACROSS STEERABLE ACCESS SOLUTION WAS SELECTED FOR USE. UPON OPENING THE VERSACROSS PACKAGE, IT WAS NOTED TO HAVE A PARTIALLY OPEN SEAL. THE DEVICE WAS NOT STERILE AND DISCARDED. THE PROCEDURE WAS CANCELLED. NO PATIENT WAS NOTED TO BE PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865662 ↗
• MalfunctionApr 1, 2026Material Integrity Problem

  IF WAS REPORTED THAT DURING A PULSED FIELD ABLATION (PFA) PROCEDURE WITH VARIPULSE TO TREAT AN ATRIAL FIBRILLATION, THE COATING OF THE VERSACROSS WIRE WAS COMING OFF AND EXPOSED AT PROXIMAL END OF THE WIRE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24760571 ↗
• MalfunctionNov 24, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PULMONARY VEIN ISOLATION TO TREAT ATRIAL FIBRILLATION VERSACROSS STEERABLE ACCESS SOLUTION WERE SELECTED FOR USE. IT HAS BEEN MENTIONED THAT BEFORE THE INSERTION STOPCOCK BROKE OFF. THE PROCEDURE WAS COMPLETED USING DIFFERENT DEVICE (SAME MODEL). THE PRODUCT IS NOT EXPECTED TO RETURN AS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638294 ↗