VersaCross Access Solution VXSK0023Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00685447007449), received between Dec 19, 2024 and Jan 21, 2025 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (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.

• DeathJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT DEATH OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN FLX PRO PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. A TRACE EFFUSION WAS NOTED PRIOR TO PROCEDURE. THE PHYSICIAN OBTAINED RIGHT FEMORAL VEIN ACCESS AND AN 18GUAGE SHEATH WAS PLACED. THE VERSACROSS SHEATH WAS INSERTED. THE PHYSICIAN DROPPED BELOW THE SEPTUM ON FIRST ATTEMPT, SO IT WAS RE-ATTEMPTED TO RE-WIRE THE SUPERIOR VENA CAVA (SVC) TO COME BACK DOWN TO THE SEPTUM. THE TRANSSEPTAL PUNCTURE WAS PERFORMED AND THE VERSACROSS SHEATH WAS EXCHANGED FOR THE WATCHMAN TRUSTEER SHEATH OVER THE WIRE. A PIGTAIL CATHETER WENT IN OVER THE WIRE. AT THIS POINT, AN EFFUSION WAS NOTED. AUTO TRANSFUSION BEGAN WITH THAT PIGTAIL CATHETER WHILE A PERICARDIOCENTESIS WAS PERFORMED. AFTER THAT THERE WERE TWO PIGTAIL CATHETERS PLACED IN THE PERICARDIAL SPACE. 12 UNITS OF PACKED RED BLOOD CELLS (PRBCS), 8 UNITS OF FRESH FROZEN PLASMA (FFP) AND 1 UNIT OF PLATELETS WERE GIVEN AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR). THE PATIENT ARRESTED BEFORE GETTING TRANSFERRED THE OR TABLE, PATIENT CHEST WAS OPENED BUT WERE UNABLE TO RESUSCITATE. IT WAS DETERMINED THE CAUSE OF DEATH WAS DUE TO PERFO

  Patient problems: Cardiac Arrest; Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 21197451 ↗
• MalfunctionDec 19, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT HAS BEEN REPORTED THAT A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A PULSE FIELD ABLATION (PVI) PROCEDURE WITH FARAPULSE. AFTER TRANSSEPTAL CROSSING, WHEN THE VERSACROSS RF WIRE WAS REMOVED, THE PHYSICIAN NOTED THAT TIP OF THE WIRE WAS BLACK. THE CHARRING COULD NOT BE REMOVED. NO PATIENT COMPLICATIONS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PRODUCT IS AVAILABLE FOR RETURN. NO OTHER ISSUES WERE REPORTED. IT WAS FURTHER REPORTED THAT THE RADIO FREQUENCY (RF) WAS APPLIED TWICE USING THE SAME RF WIRE ON THE 1 SEC CONSTANT SETTING. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20977297 ↗