RunWay™ H74938969010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729477624), received between Mar 19, 2021 and Aug 14, 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.

• MalfunctionAug 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE CATHETER WAS FRACTURED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A MODEL-6F RUNWAY FR3.5 WAS SELECTED FOR CORONARY ANGIOPLASTY. DURING INTRODUCTION, THE DISTAL TIP OF THE CATHETER FRACTURED. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT, AND A NEW RUNWAY CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN EXCELLENT CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19988037 ↗
• MalfunctionMar 19, 2021Break; Break

  IT WAS REPORTED THAT THE DEVICE FRACTURED. A 6F RUNWAY GUIDE CATHETER WAS SELECTED FOR USE IN A CORONARY ANGIOPLASTY PROCEDURE. THE RUNWAY GUIDE CATHETER WAS NOTED TO BE FRACTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11528357 ↗