Heli-FX™ EndoAnchor™ System HG-16-62-28 (UDI 00763000225971)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000225971), received between Oct 7, 2020 and Aug 26, 2021 — classified as 2 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K171427); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2021Difficult to Insert; Material Deformation; Material Integrity Problem; Difficult to Insert; Material Deformation; Material Integrity Problem

  HELI-FX ENDOANCHORS WERE BEING USED AS AN ACCESSORY DEVICE IN THE ENDOVASCULAR TREATMENT OF A TYPE I ENDOLEAK IN A NON MDT STENT GRAFT DURING THE PROCEDURE IT WAS REPORTED THAT THE MOMENT THE GUIDE WAS BENT, THE APPLIER TIP COULD NOT PASS FORWARD TO THE VESSEL WALL AND WOULD ONLY PASS ONCE THE GUIDE WAS STRAIGHTENED. A NEW GUIDE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE PER THE PHYSICIAN, THE EVENT WAS DEVICE RELATED AND MAY HAVE BEEN DUE TO DEFECTIVE INNER COATING AT THE TIP OF THE GUIDE CATHETER NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12369910 ↗
• MalfunctionOct 7, 2020Defective Device; Defective Device

  A HELI-FX ENDOANCHORING SYSTEM WAS USED PROPHYLACTICALLY WITH A NON MDT STENT GRAFT IN AN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN SAID THE GUIDE CATHETER WAS TAKING IN AIR BETWEEN PRELOADING AND DEPLOYING THE ENDOANCHORS. WHEN THE CATHETER GUIDE WAS TAKEN OUT OF THE APPLIER, AN AIR BUBBLE WAS OBSERVED. THE AIR WAS ASPIRATED TO RESOLVE THIS. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS PRODUCT RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED, AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10641028 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171427. 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