VersaCross™ Access Solution VXSK0123Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00685447019831), received between Jan 29, 2026 and Jan 29, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 10, 2025Open, Classified

   Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.

   Z-2103-2025 · Root cause: Packaging change control · FDA record ↗

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.

• MalfunctionJan 29, 2026Nonstandard Device; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT VERSACROSS ACCESS SOLUTION WAS SELECTED FOR A LEFT ATRIUM APPENDAGE (LAA) LEAK REPAIR PRIOR TO A LAA PERFORMED. AFTER RF WIRE WAS INSERTED, THE DILATOR WAS ATTEMPTED TO BE INSERTED OVER THE WIRE, HOWEVER THE OUTER LAYER OF THE WIRE SHEARD FROM THE INNER CORE. THE RF WIRE WAS REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE HAS BEEN RECEIVED AT BOSTON SCIENTIFIC'S POST MARKET LABORATORY WHERE IT IS AWAITING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24215992 ↗