VersaCross™ Large Access Solution VLAK0114Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00685447019596), received between Aug 18, 2025 and Nov 4, 2025 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Difficult 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryNov 4, 2025Positioning Failure; Positioning Problem; Positioning Failure; Positioning Problem

  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 23468584 ↗
• DeathAug 18, 2025Display or Visual Feedback Problem; Difficult to Advance; Display or Visual Feedback Problem; Difficult to Advance

  IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. DURING A CONCOMITANT PULSE FIELD ABLATION PROCEDURE, A VERSACROSS LARGE ACCESS WAS SELECTED FOR USE. A BASELINE EFFUSION WAS NOTED PRIOR TO TRANSSEPTAL. ONCE GROIN ACCESS WAS OBTAINED, THERE WAS DIFFICULTY ASCENDING THE FEMORAL VEIN AND CROSSING TRANSEPTAL. TRANSEPTAL WAS SUDDEN AND VISIBILITY WAS POOR. THE PHYSICIAN FLOSSED WITH THE VERSACROSS LARGE ACCESS. HOWEVER, THE FARADRIVE SHEATH COULD NOT GO ACROSS. SO, IT WAS ATTEMPTED WITH THE FARADRIVE DILATOR AND TRUSTEER DILATOR, THEN WAS ABLE TO CROSS WITH FARADRIVE. THE PRESSURE DROPPED A FEW TIMES AT TRANSEPTAL DURING FLOSSING. THE PRESSURE WAS TREATED. THE PHYSICIAN USED INTRACARDIAC ECHOCARDIOGRAPHY (ICE) TO WATCH FOR EFFUSION WHILE ABLATION. IT STARTED GROWING WHEN ABLATING RIGHT VEINS. A PERICARDIOCENTESIS WAS DONE AFTER FINISHING ABLATION. ONE LITER WAS DRAWN AND PATIENT WAS STABILIZED. LATER, THE PATIENT PASSED AWAY IN THE INTENSIVE CARE UNIT (ICU) FROM COMPLICATIONS. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 22832497 ↗