APTUS Heli-FX® HA-18-114Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169647602), received between Apr 7, 2017 and Apr 7, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Leak/Splash” (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.

• InjuryApr 7, 2017Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.8 CM ABDOMINAL AORTIC ANEURYSM. DIAMETER OF THE NECK BELOW THE LOWEST RENAL ARTERY WAS 29MM AND THE LENGTH OF THE NECK WAS 49MM. IT WAS REPORTED THAT A TYPE IA ENDOLEAK WAS SEEN, AND A CHIMNEY PROCEDURE WAS PERFORMED IN THE LEFT RENAL USING ANOTHER MANUFACTURER¿S STENT AND AN ENDURANT AORTIC CUFF. IMAGING SHOWED EVIDENCE OF A RESIDUAL PROXIMAL TYPE I ENDOLEAK AT THE RIGHT LATERAL ASPECT OF THE AORTIC CUFF AND THE PHYSICIAN ELECTED TO IMPLANT FOR HELI-FX ENDOANCHORS. THE FINAL ANGIOGRAM REVEALED A VERY LATE PROXIMAL TYPE I ENDOLEAK AND WAS DETERMINED BY THE PHYSICIAN TO BE UNREMARKABLE SINCE THE SUBJECT WAS FULLY HEPARINIZED. THE PROCEDURE WAS COMPLETED WITH THE PATIENT SCHEDULED FOR NORMAL FOLLOW UP. ON THE DAY FOLLOWING THE PROCEDURE TO IMPLANT THE ENDOANCHORS, THE PATIENT DEVELOPED ACUTE KIDNEY INJURY. HYDRATION WAS ADMINISTERED AND THE EVENT IS CONTINUING BUT THE PATIENT WAS DISCHARGED. THE PHYSICIAN INVESTIGATOR ASSESSED THIS TO BE RELATED TO THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED BY THE PHYSICIAN.

  Patient problems: Renal Failure

  MAUDE report 6474103 ↗