VersaCross™ Steerable Access Solution VSTK0116Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00685447019664), received between Oct 17, 2025 and Sep 18, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Failure to Advance; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829039 ↗
• MalfunctionAug 3, 2026Material Frayed; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50114154 ↗
• InjuryFeb 20, 2026Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) OCCURRED. DURING A CAVOTRICUSPID ISTHMUS (CTI)/ PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE, A VERSACROSS STEERABLE ACCESS SOLUTION WAS SELECTED FOR USE. THE PHYSICIAN COMPLETED RF CTI LINE WITH A NON-BOSTON SCIENTIFIC RF CATHETER. ROUGHLY 15-20 ABLATIONS NEEDED TO ACHIEVE CTI BLOCK. PHYSICIAN THEN ATTEMPTED TO CROSS THE SEPTUM WITH VERSACROSS STEERABLE THAT WAS USED FOR THE CTI ABLATION HOWEVER, WAS UNABLE TO CROSS THE SEPTUM WITH DILATOR AND SHEATH. IT WAS NOTED A BLOOD PRESSURE DROP TO WHICH THE PHYSICIAN USED INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND NOTED EFFUSION WAS PRESENT. A CARDIOLOGIST AND CARDIOTHORACIC (CT) WERE CONSULTED. A PERICARDIOCENTESIS WAS ATTEMPTED TO DRAW FLUID WITHOUT SUCCESS AND CT OPENED A WINDOW TO REMOVE BLOOD. THE PATIENT WAS INTUBATED AND MOVED TO INTENSIVE CARE UNIT FOR RECOVERY. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). IT WAS FURTHER REPORTED THAT RF WIRE APPEARED TO CROSS THE SEPTUM, HOWEVER WIRE MANEUVERABILITY WAS LIMITED AFTER CROSSING DUE TO PATENT FORAMEN OVALE (PFO) CLOSURE BOVINE PLUG USED IN PREVIOUS PROCEDURE. PREVIOUS PFO CLOSURE USING A BOVINE PLUG WAS KNOWN ANATOMICAL

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 24401725 ↗
• InjuryNov 4, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN PROCEDURE, A VERSACROSS LARGE ACCESS SOLUTION AND A VERSACROSS ACCESS STEERABLE SOLUTION WERE SELECTED FOR USE. THE PHYSICIAN WAS ATTEMPTING TO GAIN TRANSEPTAL ACCESS WITH DIFFICULTY ADEQUATELY IMAGING THE TRANSEPTAL LOCATION VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE PHYSICIAN WAS UTILIZING VERSACROSS LARGE ACCESS INITIALLY THEN SWITCHED OUT TO VERSACROSS STEERABLE DUE TO HAVING ISSUES REACHING THE TRANSEPTAL LOCATION DUE TO PATIENT ANATOMY AND DEVICE REACH TO THE SEPTAL BY ADDING ADDITIONAL CURVE TO THE TRANSEPTAL SYSTEM. UPON OBTAINING A POSITION ON THE FOSSA VIA TEE, THE PHYSICIAN ADVISED TO ACTIVATE RF TO GO TRANSEPTAL. THE RF WIRE ADVANCED EASILY HOWEVER PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE STEERABLE SHEATH ACROSS THE SEPTUM. THE PHYSICIAN VERIFIED TRANSEPTAL LOCATION AND INSERTED THE WATCHMAN TRUSTEER SHEATH. UPON INSERTING THE PIGTAIL CATHETER THROUGH THE SHEATH AND TAKING AN ANGIOGRAM, IT WAS NOTED CONTRAST STAINING IN THE PERICARDIAL SPACE. AT THAT TIME, IT WAS CONFIRMED VIA TEE THAT THEY WERE IN THE PERICARDIAL SPACE. THE PATIENT REMAINED STABLE AND A SM

  Patient problems: Pericardial Effusion

  MAUDE report 23468586 ↗
• MalfunctionOct 17, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE VERSACROSS STEERABLE ACCESS SOLUTION WAS SELECTED FOR USE. IT WAS NOTED THAT A PIECE OF VERSACROSS RF WIRE SHEARED OFF IN THE MIDDLE OF THE CASE. NO FURTHER DETAILS PROVIDED. NO PATIENT COMPLICATIONS REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. MEDSUN# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23329628 ↗
• MalfunctionOct 17, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE VERSACROSS STEERABLE ACCESS SOLUTION WAS SELECTED FOR USE. IT WAS NOTED THAT THE VERSACROSS WIRE SHEARED OFF. NO FURTHER DETAILS PROVIDED. NO PATIENT COMPLICATIONS REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. MEDSUN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23329052 ↗