VersaCross Steerable Access Solution VSTK0003Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00685447011941), received between Jul 12, 2023 and Jul 12, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionJul 12, 2023Material Frayed; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance; Physical Resistance/Sticking; Material Frayed; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT A VERSACROSS STEERABLE ACCESS SOLUTION WAS SELECTED FOR USE DURING AN AMULET LAAC - LEFT ATRIUM APPENDAGE CLOSURE. IT WAS DIFFICULT GOING TRANSEPTAL, SINCE THE RF BUTTON WAS PUSHED FOUR TIMES AND THE TRANSSEPTAL WAS UNSUCCESSFUL. ON THE 4TH ATTEMPT THEY WERE ABLE TO GO TRANSEPTAL. HOWEVER, WHEN THE PHYSICIAN ADVANCED THE RF WIRE, HE NOTICED THAT IT LOOKED ODD ON FLUORO SO THEY EXCHANGED FOR A NON BOSTON SCIENTIFIC WIRE. ONCE REMOVED COMPLETELY FROM THE PATIENT'S BODY, IT WAS NOTICED THAT THE RF WIRE WAS FRAYED AND SEPARATED INTO TWO PIECES. THE PHYSICIAN HAD SOME DIFFICULTY CATCHING ON THE SHEATH UPON REMOVAL OF THE RF WIRE DUE TO FRAYING, BUT NOT MUCH. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17306389 ↗