VersaCross™ Steerable Access Solution VSTK0122Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00685447019718), received between Aug 19, 2025 and Sep 9, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Failure 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Material Perforation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695240 ↗
• MalfunctionFeb 3, 2026Nonstandard Device

  IT WAS REPORTED THAT A VERSACROSS STEERABLE ACCESS SOLUTION WAS SELECTED FOR USE IN A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE. DURING THE PROCEDURE, DILATOR WAS WITHDRAWN FROM THE SHEATH AND WIRE WAS THEN READVANCED, BUT DILATOR WAS UNABLE TO PASS BEYOND THE TIP OF THE SHEATH. IT APPEARS THAT WIRE ENTERED AN IRRIGATION HOLE AT THE DISTAL END OF THE SHEATH, AND DILATOR FOLLOWED INTO THE IRRIGATION PORT. SHEATH AND DILATOR WERE REMOVED FROM THE BODY, AND IT WAS FOUND THAT DISTAL IRRIGATION HOLE OF THE SHEATH WAS ENLARGED. AT THAT POINT, THE SHEATH WAS REPLACED AND PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATION WAS REPORTED. THE SHEATH IS NOT EXPECTED TO BE RETURN FOR ANALYSIS AS IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251039 ↗
• InjuryAug 19, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT A CARDIAC PERFORATION AND PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A ATRIAL FIBRILLATION ABLATION (PULMONARY VEIN ISOLATION) REDO PROCEDURE, A VERSACROSS STEERABLE ACCESS SOLUTION WAS SELECTED FOR USE. DURING TRANSSEPTAL, THERE WERE FIVE (5) ATTEMPTS WERE MADE USING RADIO FREQUENCY AT ONE SECOND CONSTANT SETTING TO CROSS THE SEPTUM. THIS WAS UNSUCCESSFUL. A PERICARDIAL EFFUSION WAS NOTED IMMEDIATELY AND THE PHYSICIAN PERFORMED AN EMERGENCY PERICARDIOCENTESIS. A 500 ML OF BRIGHT BLOOD WAS REMOVED FROM THE PERICARDIUM. THE PATIENT WAS NOT IN CARDIAC ARREST. ONCE STABILIZED, THE PATIENT WAS EXTUBATED AND TRANSFERRED TO THE CARDIAC INTENSIVE CARE UNIT WITH A PERICARDIAL DRAIN. THE FOLLOWING DAY, THE DRAIN WAS REMOVED AND FOLLOW-UP ECHOCARDIOGRAM WAS STABLE. THE PATIENT WAS DISCHARGED HOME AND ABLATION PROCEDURE WILL BE RESCHEDULED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). IN THE PHYSICIAN'S OPINION, THE ACCESS SOLUTION DEVICES DID NOT CONTRIBUTED TO THE PATIENT COMPLICATIONS.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 22841675 ↗