RunWay™ H74938969720Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729478973), received between Oct 7, 2019 and Jul 10, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE CATHETER WAS BROKEN. A 6F RUNWAY CATHETER-GUIDE WAS SELECTED FOR USE. DURING PREPARATION, WHEN REMOVING THE CATHETER FROM THE PACKAGING, IT WAS NOTED THAT THE TIP WAS BROKEN. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19716344 ↗
• MalfunctionJun 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. THE RUNWAY GUIDE CATHETER WAS SELECTED FOR USE IN A CORONARY ANGIOPLASTY PROCEDURE. DURING INSERTION, IT WAS NOTED THAT THE DISTAL PORTION OF THE DEVICE WAS FRACTURED. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17240894 ↗
• MalfunctionMay 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. A 6F RUNWAY VL3.5 GUIDE CATHETER WAS SELECTED FOR USE. WHEN TAKING THE PRODUCT OUT OF THE PACKAGING, IT WAS OBSERVED THAT THE TIP OF THE CATHETER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17026442 ↗
• MalfunctionApr 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT A TIP FRACTURE OCCURRED. A TIP FRACTURE WAS OBSERVED WHEN THE 6F RUNWAY GUIDE CATHETER WAS REMOVED FROM THE PACKAGE DURING PREPARATION. ANOTHER SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16662836 ↗
• MalfunctionApr 29, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CATHETER HAD AN EXTRA RING OF PLASTIC AT THE TIP. A 6F RUNWAY VL3.5 CATHETER WAS SELECTED FOR TREATMENT, HOWEVER, AN EXTRA RING OF PLASTIC AT THE TIP WAS NOTED UPON OPENING THE DEVICE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14256015 ↗
• MalfunctionOct 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP FRACTURE OCCURRED. A VL3.5 RUNWAY 6F CATHETER-GUIDE WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON OPENING THE CATHETER PACKAGE, THE TIP WAS FRACTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9162772 ↗