RunWay™ H74938969680Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729478836), received between Aug 4, 2020 and Aug 4, 2020 — classified as 1 injury.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2020Break; Difficult to Remove; Material Deformation; Break; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT THE SURGERY WAS REQUIRED TO REMOVE THE CATHETER. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE FEMORAL ARTERY SEEMED TO BE TORTUOUS JUST PAST THE SHEATH INSERTION. A 6F RUNWAY AL1 SH GUIDE CATHETER WAS SELECTED FOR USE. AFTER THE CATHETER WAS INSERTED, THREE KINKS WERE OBSERVED ON IT. THE PHYSICIAN TRIED TO STRAIGHTEN THE KINKS WITH A 0.38 WIRE WHILE PART OF THE CATHETER REMAINED INSIDE THE PATIENT. THE CATHETER BROKE AT THE PROXIMAL SECTION. THE PORTION OF THE DEVICE INSIDE THE PATIENT WAS UNABLE TO BE RETRIEVED. THE PATIENT WAS SENT TO THEATRE TO HAVE THE AL1 GUIDE REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10364244 ↗