Heli-FX™ EndoAnchor™ System HG-16-62-28 (UDI 00763000025267)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000025267), received between Apr 17, 2018 and Apr 12, 2019 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K171427, K182957); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2019Material Deformation; Material Deformation

  A HELI-FX APPLIER AND GUIDE WERE USED FOR THE ENDOVASCULAR TREATMENT OF A PATIENT.   IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, AFTER THE PHYSICIAN IMPLANTED, THE FIRST ENDOANCHOR, THE GUIDE AND THE APPLIER BECAME DEFORMED, WITH THE WIRES BECOMING EXPOSED. THE PHYSICIAN WAS ABLE TO DEFLECT THE GUIDE CATHETER BUT WAS NOT ABLE TO TORQUE THE ENTIRE SHEATH. IT WAS ALSO REPORTED THAT THE APPLICATOR FAILED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED, DUE TO THE TORTUOSITY OF THE ILIAC ARTERIES. HOWEVER, AS PER THE PHYSICIAN, THE TORTUOSITY DOES NOT EXPLAIN THE MECHANICAL FAILURE REGARDING THE STRUCTURAL INTEGRITY OF THE SHEATH WHICH NO DOUBT CONTRIBUTED TO LOSS OF MANEUVERABILITY. THE PHYSICIAN ALSO STATED THAT THE PATIENT HAD NO HARM AS A RESULT OF THIS MALFUNCTION DUE TO THE FACT THAT THE SHEATH WAS CONSTRAINED WITHIN ANOTHER GUIDE SHEATH. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8507950 ↗
• MalfunctionMar 21, 2019Component Missing; Component Missing

  A HELI-FX ENDOANCHORING SYSTEM WAS PLANNED TO BE IMPLANTED TO PREVENT A TYPE IA ENDOLEAK IN A PREVIOUSLY IMPLANTED MEDTRONIC STENT GRAFT SYSTEM. IT WAS REPORTED DURING THE INDEX PROCEDURE WHEN THE GUIDE BOX WAS OPENED IT WAS NOTED THERE WAS NO OBTURATOR PRESENT IN THE BOX. A SECOND GUIDE BOX WAS OPENED AND THE OBTURATOR USED TO SUCCESSFULLY IMPLANT 9 ENDOANCHORS. THE CAUSE OF THE EVENT WAS DETERMINED AS PRODUCT RELATED. NO ADVERSE EVENT WAS ASSOCIATED WITH THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8439869 ↗
• MalfunctionNov 8, 2018Device Damaged by Another Device; Device Damaged by Another Device

  A HELI-FX ENDO ANCHORING SYSTEM WAS USED PROPHYLACTICALLY IN CONJUNCTION WITH AN ENDURANT STENT GRAFT SYSTEM DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER THE FIRST ENDO ANCHOR HAD BEEN DEPLOYED AND WHEN THE GUIDE WAS STRAIGHTENED, DIFFICULTY WAS NOTED WHEN ATTEMPTING TO RETRACT THE APPLIER. THE APPLIER WAS REMOVED WITH THE GUIDE AND UPON INSPECTION OF THE GUIDE THE TIP END WAS OBSERVED TO BE DEFORMED. A SECOND GUIDE WAS OPENED HOWEVER DURING DEFLECTION (FOLLOWING THE IFU) A SNAP NOISE WAS HEARD AND THE GUIDE CEASED TO DEFLECT ANY FURTHER. A THIRD SG-64 GUIDE WAS THEN USED WITH NO FURTHER ISSUES NOTED AND THE PROCEDURE COMPLETED SUCCESSFULLY. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8051492 ↗
• InjuryJul 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HELI-FX ENDOANCHOR SYSTEM WAS USED AS AN ACCESSORY DEVICE FOR AN UNKNOWN ENDOVASCULAR TREATMENT WITH A NON-MDT STENT GRAFT SYSTEM. THE COOK STENT GRAFT HAD BEEN PREVIOUSLY IMPLANTED APPROXIMATELY 8 YEARS EARLIER AND ENDOANCHORS WERE BEING IMPLANTED TO FIX MIGRATION AND AN UNKNOWN TYPE ENDOLEAK. DURING THE ENDOANCHOR PROCEDURE A DISTAL COOK ZENITH STENT GRAFT, A VIABAHN STENT GRAFT AND ANOTHER PROXIMAL STENT GRAFT WERE IMPLANTED AND 5 ENDOANCHORS WERE IMPLANTED IN THE DISTAL NECK AS PART OF THE PLANNED PROCEDURE. TWO WEEKS AFTER THE ENDOANCHOR INDEX PROCEDURE, IT WAS REPORTED THE PATIENT SUFFERED FROM AN INFECTED GROIN. THE EVENT WAS TREATED WITH MEDICATION AND ANOTHER SURGICAL PROCEDURE. THE EVENT RESOLVED 3 WEEKS LATER. THE EVENT HAS BEEN ASSESSED AS RELATED TO THE INDEX PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7663257 ↗
• MalfunctionApr 17, 2018Device Damaged by Another Device; Positioning Problem; Device Damaged by Another Device; Positioning Problem

  A HELI-FX GUIDE WAS USED PROPHYLACTICALLY IN CONJUNCTION WITH A MEDTRONIC STENT GRAFT FOR TREATMENT OF A PATIENT. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE EVAR WAS PERFORMED WITHOUT COMPLICATION. THE HELI-FX SYSTEM SUCCESSFULLY IMPLANTED ONE ENDOANCHOR. WHILE ATTEMPTING TO ORIENT THE HELI-FX GUIDE TO DEPLOY THE SECOND ENDOANCHOR, THE HELI-FX GUIDE WAS CAUGHT UP ON THE PROXIMAL STENT GRAFT EDGE WHILE BEING DEFLECTED. IT WAS OBSERVED THAT THE HELI-FX GUIDE LOST ITS ABILITY TO DEFLECT AND CORRECTLY ORIENT THE ENDOANCHOR. THIS HELI-FX GUIDE WAS REMOVED AND REPLACED WITH A NEW HELI-FX GUIDE WHICH SUCCESSFULLY IMPLANTED A FURTHER 7 ENDOANCHORS WITHOUT COMPLICATION. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO USER ERROR AS THE PHYSICIAN CONTINUED TO DEFLECT THE GUIDE AFTER IT WAS CAUGHT ON THE GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7435534 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171427, K182957. One submission often covers many models, so check the product and lot details in each record.

• Z-3227-2017 · Sep 13, 2017 · Terminated
  Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only The Heli-FX EndoAnchor System is intended to provide fixation and sea