VersaCross Access Solution VXSK0011 (REF NA)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00685447007326), received between Apr 28, 2025 and Apr 28, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Thermal Decomposition of Device; Device Displays Incorrect Message; Thermal Decomposition of Device; Device Displays Incorrect Message

  IT HAS BEEN REPORTED THAT A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. IT WAS MENTIONED THAT DURING THE PROCEDURE, THE TIP OF THE RF WIRE WAS NOTED CHAR (BLACK). KEEP SHOWING ERROR CODE METAL DETECTED. THUS, THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE REASON BEHIND THE EVENT IS UNKNOWN. THE PROBLEM ASSOCIATED WITH LABELED USE. THE EVENT OCCURRED INSIDE THE PATIENT BODY AND NO PATIENT COMPLICATION WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURN FOR ANALYSIS (DISPOSED). IT WAS MENTIONED THAT RF WAS DELIVERED 5 TIMES. ACT WAS OVER 300S. HEPARIN WAS ADMINISTERED BEFORE THE FEMORAL ACCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920181 ↗