APTUS Heli-FX® HG-16-62-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169647626), received between May 22, 2017 and Feb 7, 2019 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HELI-FX ENDOANCHORS AND AN ENDURANT AORTIC CUFF WERE IMPLANTED FOR THE TREATMENT OF MIGRATION AND A TYPE IA ENDOLEAK IN A TALENT STENT GRAFT SYSTEM. THE TALENT STENT GRAFT WAS ORIGINALLY IMPLANTED APPROXIMATELY 13 YEARS PREVIOUSLY. THE CURRENT AAA DIAMETER MEASURED 42.8MM. THE DIAMETER AT THE PROXIMAL AORTIC NECK MEASURED 33.5MM-33.3MM WITH A 30 DEGREE ANGULATION. MODERATE THROMBUS AND LOCALISED CALCIFICATION WERE OBSERVED AT THE SEAL ZONE. IT WAS REPORTED DURING THE INDEX PROCEDURE UNINTENTIONAL PARTIAL COVERAGE OF THE RIGHT RENAL ARTERY OCCURRED. A NON MDT RENAL STENT WAS IMPLANTED AND THE EVENT RESOLVED. IT WAS FURTHER REPORTED APPROXIMATELY 2 WEEKS POST THE INDEX PROCEDURE, RIGHT RENAL ARTERY STENT THROMBOSIS OCCURRED WITH A DECREASE IN RENAL FUNCTION. A CT CONFIRMED LOWER POLE ISCHEMIA/INFARCT OF THE RIGHT KIDNEY. THE EVENT IS CURRENTLY UNRESOLVED WITH PERMANENT ADVERSE SEQUELAE. PER THE INVESTIGATOR THE CAUSE OF THE RIGHT RENAL STENT THROMBOSIS WAS RELATED TO THE INDEX PROCEDURE. THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Ischemia; Renal Failure; Thrombus

  MAUDE report 8314164 ↗
• InjuryMar 29, 2018Detachment Of Device Component; Difficult to Insert; Detachment Of Device Component; Difficult to Insert

  A HELI-FX GUIDE, APPLIER AND ENDOANCHORS WERE USED PROPHYLACTICALLY IN THE ENDOVASCULAR TREATMENT OF THE PATIENT FOR AN INFRARENAL ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE HELI-FX GUIDE AND APPLIER INITIALLY PASSED EASILY VIA THE RIGHT FEMORAL SHEATH INTO THE PROXIMAL PORTION OF THE STENT GRAFT. 3 ENDOANCHORS WERE PLACED IN THE AP POSITION. IT WAS NOTED THAT THERE WAS SOME DIFFICULTY IN PASSING THE HELI-FX APPLIER THROUGH THE GUIDE FOR PLACEMENT OF THE THIRD ENDOANCHOR. A FOURTH ENDOANCHOR WAS PLACED IN THE OBLIQUE POSITION AND AGAIN SOME DIFFICULTY WAS NOTED ON PASSING THE HELI-FX APPLIER. ANOTHER ENDOANCHOR ON THE LEFT WAS ATTEMPTED BUT THE APPLIER COULDN'T BE PASSED THROUGH THE GUIDES DISTAL PORTION. THE ENDOANCHOR AND SHEATH WERE REMOVED AND REPLACED WITH A STIFF WIRED AND CONTRAST IMAGING SHOWED GOOD APPOSITION PROXIMALLY WITH NO ENDOLEAK. IT WAS NOTICED ON CONTRAST IMAGING THAT THE METAL RING OF THE END OF THE HELI-FX GUIDE HAD COME FREE IN THE FEMORAL ARTERY. AN ANGLED GUIDEWIRE WAS PASSED THROUGH THE RIGHT FEMORAL SHEATH, THROUGH THE RING AND A 12MM BALLOON WAS USED TO REMOVE IT. IT WAS REPORTED THAT THE CAUSE OF THE EVENT IS UNKNOWN. IT IS REPORTED THAT THE PATI

  Patient problems: Injury

  MAUDE report 7380675 ↗
• InjuryNov 13, 2017Device Damaged by Another Device; Device Damaged by Another Device

  A HELI-FX APPLIER WAS USED TO TREAT A TYPE 1A ENDOLEAK FROM ANOTHER MANUFACTURER'S STENT GRAFT. IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY DEPLOYED TWO ENDOANCHORS. AT THIS POINT THE BLUE ERROR LIGHT WAS BLINKING. THE PHYSICIAN HAD PUSHED THE APPLIER INTO THE DEFLECTED GUIDE CATHETER VERY HARD, AND THAT THEY BELIEVED THIS MAY HAVE CAUSED THE ISSUE. LATER ON IN THE PROCEDURE, A BUBBLE WAS NOTED IN THE AORTA, WHICH WAS REMOVED WITH A 2 CATHETER BY THE PHYSICIAN. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS USER ERROR. A NEW APPLIER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Embolism

  MAUDE report 7023891 ↗
• MalfunctionAug 15, 2017Break; Break

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT AFTER THE STENT GRAFT WAS IMPLANTED THERE WAS A TYPE IA ENDOLEAK. THE DECISION WAS MADE TO USE ENDOANCHORS. THE RADIOPAQUE MARKER ON GUIDE CAME OFF AFTER SECOND ENDOANCHOR DEPLOYMENT. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS DEVICE RELATED. PER THE PHYSICIAN, THE CAUSE OF THE ENDOLEAK WAS DUE TO THE PATIENT ANATOMY OF A SHORT CONICAL PROXIMAL AORTIC NECK. THE ENDOLEAK WAS FOUND TO HAVE RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6793666 ↗
• MalfunctionJun 5, 2017Kinked; Positioning Problem; Kinked; Positioning Problem

  A HELI-FX GUIDE WAS USED AS AN ACCESSORY DEVICE WITH A VALIANT STENT GRAFT SYSTEM FOR THE ENDOVASCULAR TREATMENT AN UNKNOWN AORTIC DISEASE AS PROPHYLACTIC. IT WAS REPORTED THAT AS THE PHYSICIAN WAS ATTEMPTING TO DEFLECT THE TIP OF THE GUIDE AND POSITION IT AGAINST THE WALL OF THE STENT/AORTA IT WAS NOT POSSIBLE TO ADVANCE THE APPLIER IN ORDER TO PLACE ENDOANCHOR. IT APPEARED THAT THE TEFLON TAPE ON THE DISTAL PART OF GUIDE WAS KINKED. THE PHYSICIAN REMOVED THE GUIDE AND THAT IS WHAT APPEARED TO HAVE HAPPENED. ANOTHER 28MM GUIDE WAS USED TO SUCCESSFULLY PLACE 6 ENDOANCHORS. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DEVICE RELATED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6612805 ↗
• MalfunctionMay 22, 2017Break; Positioning Problem; Break; Positioning Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT AFTER THE STENT GRAFT WAS IMPLANTED THERE WAS A TYPE I ENDOLEAK. THE PHYSICIAN DECIDED TO USE HELI-FX ENDOANCHORS TO RESOLVE THE ENDOLEAK. TWO GUIDES WERE USED AND BOTH 28 GUIDES BROKE WHILE TRYING TO GET DIFFERENT ANGLES. THE PHYSICIAN USED AN ENDURANT CUFF AND THE ENDOLEAK RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE BREAK AND THE ENDOLEAK ARE UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6583383 ↗