VersaCross Access Solution VXSK0032 (UDI 00685447017356)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00685447017356), received between Nov 5, 2024 and Jan 13, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Flush” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2025Difficult to Flush; Difficult to Flush

  IT WAS REPORTED DURING A CONCOMITANT ATRIAL FIBRILLATION ABLATION AND WATCHMAN PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. IT WAS NOTED THAT AFTER TAKING DILATOR OUT, IT WOULD NOT FLUSH. IT WAS TRIED TO FLUSH HARD. HENCE, THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21144996 ↗
• MalfunctionNov 8, 2024Flushing Problem; Mechanical Problem; Flushing Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING ATRIAL FIBRILLATION ABLATION PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE PHYSICIAN MENTIONED THAT UPON TRYING TO PRE-MAP WITH ANOTHER CATHETER IN THE SHEATH, THERE WAS A LOT OF AIR. AN ISSUE WAS NOTED WITH THE SHEATH/VALVE OPENING AND IT WOULD NOT ALLOW TO FLUSH PROPERLY. HENCE, THE SHEATH WAS REPLACED WITH FARADRIVE AS THE PHYSICIAN WAS PLANNING ON EXCHANGING LATER IN PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). THERE WERE NO OTHER DEVICE PRESENT IN THE SHEATH WHEN BUBBLES WERE SEEN. IT WAS ATTEMPTED TO ASPIRATE THE SHEATH, BUT THIS WAS THE TIME WHY IT WAS NOT FLUSHING/ASPIRATING. IT IS BELIEVED THE VALVE WAS ATTEMPTED TO OPEN AND CLOSE TO SEE IF THAT WOULD HELP. THERE WAS NO DAMAGE TO THE LUER. NO AIR WAS NOTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20640177 ↗
• MalfunctionNov 5, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE DURING A MITRALCLIP PROCEDURE. DURING THE CASE, IT WAS NOTED THAT THE COATING ON THE WIRE WAS PEELED OFF. HENCE, THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFUL. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609368 ↗