APTUS Heli-FX® SG-64Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169647572), received between Jun 15, 2017 and May 21, 2018 — classified as 2 deaths, 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2018Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT 4 HELI-FX ENDOANCHORS WERE IMPLANTED IN THE 79.2MM DIAMETER ANEURYSM DUE TO NECK DILATATION APPROXIMATELY 5 YEARS LATER. AN ENDURANT II LIMB EXTENSION WAS ALSO IMPLANTED DURING THE SAME PROCEDURE. APPROXIMATELY 16 MONTHS POST IMPLANTATION OF THE ENDOANCHORS, IT WAS NOTED THAT A TYPE IA ENDOLEAK WAS OBSERVED. AS PER THE INVESTIGATOR, THE EVENT WAS POSSIBLY RELATED TO THE ENDOGRAFT. APPROXIMATELY 17 MONTHS POST IMPLANTATION OF THE ENDOANCHORS, INTERVENTION TO TREAT THE TYPE IA ENDOLEAK AND ANEURYSM EXPANSION WAS CARRIED OUT, DURING THE PROCEDURE BALLOONING WAS PERFORMED BUT THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY AND THE EVENT WAS NOT RESOLVED. A FURTHER RE-INTERVENTION WAS CARRIED OUT APPROXIMATELY 1 WEEK LATER. DURING THIS PROCEDURE, AN AORTIC CUFF WAS IMPLANTED ALONG WITH ADDITIONAL ENDOANCHORS AND A NON MDT STENT. THE PROCEDURE WAS SUCCESSFUL AND THE EVENT WAS RESOLVED, NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7530040 ↗
• DeathApr 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HELI-FX APPLIER AND ENDOANCHORS AND ENDURANT AORTIC CUFF WERE USED IN THE ENDOVASCULAR TREATMENT OF THE PATIENT. THE MAXIMUM DIAMETER OF THE ANEURYSM WAS 54.4MM. IT WAS REPORTED THAT THE PATIENT HAD AN ANEURX MAIN BODY AND ANEURX ILIAC EXTENSION CUFFS IMPLANTED APPROXIMATELY 14.5 YEARS BEFORE. THE MAXIMUM DIAMETER OF THE ANEURYSM WAS 54.4MM. IT WAS REPORTED THAT DURING THE INTERVENTION, 4 ENDOANCHORS WERE IMPLANTED IN THE MAIN BODY AT THE PROXIMAL NECK. IT WAS NOTED THAT THE PATIENT EXPIRED APPROXIMATELY 2 YEARS POST INTERVENTION FROM AN UNKNOWN CAUSE. RELATIONSHIP BETWEEN THE PATIENT DEATH AND THE STUDY DEVICE OR PROCEDURE WAS NOT REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death

  MAUDE report 7435558 ↗
• DeathJun 15, 2017Difficult to Remove; Difficult to Remove

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT FOR ANOTHER MANUFACTURER¿S DISPLACED DISTAL, MIGRATED, AND THE PROXIMAL STENT CROWN APPEARED TO HAVE PERFORATED THE AORTA AND ANEURYSM RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INTERVENTION THE ANGIOGRAM DEMONSTRATED EXTRAVASATION IN THE INFRARENAL AORTIC NECK. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT AORTIC CUFF AT THE RENAL ARTERIES IN THE STANDARD MANNER. POST DILATATION OF THE ENDURANT STENT GRAFT WAS DONE WITH ANOTHER MANUFACTURER¿S BALLOON. ANGIOGRAPHY DEMONSTRATED A PERSISTENT TYPE IA ENDOLEAK/EXTRAVASATION. ANOTHER ENDURANT AORTIC CUFF WAS IMPLANTED IN THE STANDARD MANNER WITH POST BALLOONING. THE PROXIMAL TYPE I ENDOLEAK PERSISTED. THE PHYSICIAN IMPLANTED SEVEN HELI-FX ENDOANCHORS IN THE STANDARD MANNER IN THE INFRARENAL AORTIC NECK. ANGIOGRAPHY DEMONSTRATED RESOLUTION OF THE PROXIMAL TYPE I ENDOLEAK. IT WAS REPORTED THAT DURING THE REMOVAL OF THE SHEATHES THE PATIENT EXPERIENCE CARDIAC ARREST. EFFORTS TO RESUSCITATE THE PATIENT WERE INITIATED, HOWEVER THE PATIENT WAS PRONOUNCED DECEASED AFTER SEVERAL MINUTES. PER THE PHYSICIAN, THE CAUSES OF THE EVENTS

  Patient problems: Cardiac Arrest; Death

  MAUDE report 6644496 ↗