RAILWAY RW5VBTBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032076869), received between Mar 28, 2024 and Jan 25, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryJan 25, 2026Detachment of Device or Device Component

  AS REPORTED, A 5F RAILWAY SHEATHLESS ACCESS SYSTEM VISTA BRITE TIP BARE WIRE BROKE OFF IN THE PATIENT¿S BODY. AN ADDITIONAL INTERVENTIONAL RADIOLOGY PROCEDURE WAS REQUIRED, WHICH INVOLVED SNARING THE DEVICE FRAGMENT OUT OF THE BODY VIA FEMORAL APPROACH. THERE WAS NO ADDITIONAL REPORTED PATIENT INJURY. THE ACCESS SITE VESSEL WAS NOT CALCIFIED BUT WAS DESCRIBED AS SEVERELY TORTUOUS. THE DEVICE WAS FLUSHED PRIOR TO USE, AND THE VESSEL DILATOR WAS SNAPPED INTO PLACE AT THE HUB. DIFFICULTIES DURING INSERTION WERE ATTRIBUTED TO A SMALL VESSEL WITH SEVERE TORTUOSITY. THERE WERE NO DIFFICULTIES WITHDRAWING THE DEVICE; HOWEVER, UPON WITHDRAWAL, A FRAGMENT WAS LEFT BEHIND AFTER ATTEMPTING TO ADVANCE THE SYSTEM THROUGH SEVERE TORTUOSITY, AND REPEATED TORQUING DURING INSERTION RESULTED IN FRACTURING AND SHEARING OFF THE DILATOR. NO DAMAGE WAS NOTED ON THE DEVICE OR PACKAGING PRIOR TO OPENING. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), THE USER WAS TRAINED ON THE DEVICE, AND THE PATIENT WAS REPORTED TO BE STABLE AND DISCHARGED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS ALL PRODUCTS FROM THE PROCEDURE WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24175877 ↗
• MalfunctionMar 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, WHEN THE VESSEL DILATOR OF A 5F RAILWAY SHEATHLESS ACCESS SYSTEM WAS REMOVED FROM THE PACKAGING, IT SPLIT IN TWO. A NEW UNKNOWN RAILWAY DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE BOX AND PACKAGING WERE INTACT. THE DEVICE WAS INSPECTED PRIOR TO USE. THERE WERE NO ANOMALIES NOTED WHEN IT WAS REMOVED FROM THE PACKAGE. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT APPLICABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18997100 ↗