Heli-FX™ EndoAnchor™ System HG-18-90-42 (UDI 00763000226008)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000226008), received between Aug 2, 2022 and Aug 2, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A HELI-FX ENDOANCHORING SYSTEM WAS USED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT WHEN ADVANCING THE ENDOANCHOR, THE RADIOPAQUE MARKER ON THE GUIDE DISLODGED AND SEPARATED FROM THE GUIDE. IT WAS REPORTED THE PROCEDURE WILL BE RE-SCHEDULED WHEN ANOTHER GUIDE BECOMES AVAILABLE. THERE WAS NO PATIENT INJURY.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15146191 ↗

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