RunWay™ H74938969060Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729477679), received between Oct 26, 2020 and Jun 20, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2023Break; Break

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. A 6F RUNWAY GUIDE CATHETER WAS UNPACKED; HOWEVER, DEVICE WAS NOTED TO BE DAMAGED WITH BREAKAGES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17162331 ↗
• MalfunctionJun 13, 2023Break; Break

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. TWO 6F RUNWAY GUIDE CATHETERS WERE UNPACKED; HOWEVER, DEVICES WERE NOTED TO BE DAMAGED WITH BREAKAGES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17119336 ↗
• MalfunctionJun 13, 2023Break; Break

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. TWO 6F RUNWAY GUIDE CATHETERS WERE UNPACKED; HOWEVER, DEVICES WERE NOTED TO BE DAMAGED WITH BREAKAGES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17119335 ↗
• MalfunctionOct 26, 2020Break; Break

  IT WAS REPORTED THAT CATHETER BROKE DURING UNPACKING. A 6F RUNWAY FL3.5 RUNWAY CATHETER WAS SELECTED FOR A CORONARY ANGIOPLASTY. WHEN TAKING THE CATHETER OUT OF ITS PACKAGING, THE CATHETER BODY WAS BROKEN. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10734208 ↗