RunWay™ H74938969250Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729477884), received between Mar 1, 2023 and Mar 1, 2023 — classified as 1 death.

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

• DeathMar 1, 2023Break; Difficult to Remove; Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Remove; Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEATH OCCURRED. A RUNWAY GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE CATHETER WAS BEING TORQUED TO ENGAGE THE CORONARY ARTERY, THE CATHETER BECAME TWISTED. AN ATTEMPT WAS MADE TO PASS A WIRE, BUT IT WAS UNSUCCESSFUL. AFTER SEVERAL MORE ATTEMPTS, THE PHYSICIAN PULLED THE KNOTTED GUIDE CATHETER ALONG WITH THE SHEATH THROUGH THE ARTERIOTOMY, BUT THE HUB OF THE CATHETER BECAME DETACHED, LEAVING THE REST OF THE GUIDE INSIDE THE PATIENT. AFTER AN ATTEMPT TO SNARE THE CATHETER FAILED, THE PATIENT WAS SENT TO COMPUTERIZED TOMOGRAPHY (CT) WHERE THEY PASSED AWAY DUE TO RETROPERITONEAL BLEED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16464370 ↗