RunWay™ H749389695730Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729478379), received between Sep 29, 2021 and Jul 5, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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.

• MalfunctionJul 5, 2024Break; Material Perforation; Break; Material Perforation

  IT WAS REPORTED THAT THE SHAFT BROKE AND HAD A HOLE. A RUNWAY GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SHAFT BROKE, AND A HOLE WAS ALSO NOTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19684688 ↗
• MalfunctionSep 29, 2021Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  IT WAS REPORTED THAT PACKAGING DAMAGE OCCURRED. DURING PREPARATION OF A RUNWAY GUIDE CATHETER IT WAS NOTED THAT THE DEVICE WAS KINKED AND THE PACKAGING WAS DAMAGED SO THAT STERILITY WAS COMPROMISED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12548787 ↗