Heli-FX™ EndoAnchor™ System HG-18-90-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000025281), received between Apr 17, 2018 and Feb 22, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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. 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.

• MalfunctionFeb 22, 2021Failure to Unfold or Unwrap; Detachment of Device or Device Component; Failure to Unfold or Unwrap; Detachment of Device or Device Component

  AN HELI-FX ENDO-ANCHORING SYSTEM WAS ATTEMPTED TO BE USED ALONG WITH A VALIANT STENT GRAFT WHICH WAS IMPLANTED IN AN ENDOVASCULAR PROCEDURE TO TREAT AN ENDOLEAK IN A NON-MEDTRONIC STENT GRAFT IMPLANTED 2 YEARS AGO IN THE DISTAL PORTION CLOSE TO THE CELIAC TRUNK IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER THE FIRST TWO ENDOANCHORS HAD BEEN IMPLANTED, DEFLECTION ISSUES WERE ENCOUNTERED IT WAS NOTED THAT AFTER THE SECOND ENDOANCHOR WAS IMPLANTED IT APPEARED TO DISLODGE THE RADIOPAQUE MARKER ON THE GUIDE, IT WAS REPORTED THE MARKER COULD NOT BE CAPTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11358699 ↗
• MalfunctionMay 4, 2018Break; Break

  A HELI-FX APPLIER AND ENDOANCHORS WERE PLANNED TO BE USED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A TYPE IA ENDOLEAK OF A NON-MDT THORACIC STENT GRAFT ALONG WITH PENUMBRA COILS AND ONYX. IT WAS REPORTED THAT HELI-FX GUIDE HG-18-90-32 (LOT NUMBER 0008847767) BROKE DURING THE PROCEDURE, THAT THE CATHETER DIDN¿T TURN, AND THE HANDLE WAS SEPARATED FROM THE CATHETER. THE PHYSICIAN REPORTED THE CAUSE OF THE EVENT TO BE PRODUCT RELATED AND REPORTED LOW QUALITY OF THE PRODUCT ALONG WITH COMPLEX ANATOMY DUE TO ANGULATION. A SECOND HELI-FX GUIDE G-18-90-32 (LOT NUMBER 0008847776) WAS ALSO USED DURING THE PROCEDURE. IT WAS REPORTED THAT THIS HELI-FX GUIDE ALSO BROKE DURING THE PROCEDURE, THAT THE CATHETER DIDN¿T TURN, AND THE HANDLE WAS SEPARATED FROM THE CATHETER. AGAIN, THE PHYSICIAN REPORTED THE CAUSE OF THE EVENT TO BE PRODUCT RELATED AND REPORTED LOW QUALITY OF THE PRODUCT ALONG WITH COMPLEX ANATOMY DUE TO ANGULATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7487511 ↗
• MalfunctionApr 17, 2018Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  A HELI-FX GUIDE, AND HELI-FX APPLIER AND ENDOANCHORS WERE USED PROPHYLACTICALLY IN THE ENDOVASCULAR TREATMENT OF THE PATIENT FOR ANO THER MANUFACTURERS STENT GRAFT. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE AFTER THE IMPLANTATION OF THE FIRST TWO ENDOANCHORS THE PHYSICIAN WAS NOT ABLE TO ADVANCE THE HELI-FX APPLIER THROUGH THE HELI-FX GUIDE WHEN THE GUIDE WAS BENT. AS TWO ENDOANCHORS HAD BEEN SUCCESSFULLY IMPLANTED THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INTERVENTION. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO OBSTRUCTION OF THE TIP OF THE GUIDE BY A PART OF THE GUIDE ITSELF WHICH WAS NOTED AFTER REMOVAL OF THE GUIDE FROM THE PATIENT. IT WAS NOTED THAT THE APPLIER WORKED SUCCESSFULLY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7435520 ↗

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