Heli-FX™ EndoAnchor™ System HA-18-114 (UDI 00763000225940)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000225940), received between Dec 3, 2019 and May 4, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Malposition of Device” (4 reports).

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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2022Leak/Splash; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  A HELI-FX ENDOANCHORING SYSTEM WAS USED DURING AN ENDOVASCULAR PROCEDURE IN ORDER TO PLACE ENDOANCHORS IN AN EXISTING VALIANT CAPTIVIA GRAFT.  IT WAS REPORTED DURING THE INDEX PROCEDURE ONE ENDOANCHOR DID NOT PENETRATE THE AORTIC WALL AND BECAME LOOSE IN THE DESCENDING AORTA. THE PHYSICIAN PLACES ANOTHER GRAFT OVER IT TO HOLD IT IN PLACE AND THE ISSUE WAS RESOLVED.  AS PER THE PHYSICIAN THE CAUSE OF THE INACCURATE DELIVERY WAS AS A RESULT OF THE PATIENTS ANATOMY.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14278960 ↗
• InjuryFeb 16, 2022Malposition of Device; Malposition of Device

  HELI-FX ENDOANCHORS WERE IMPLANTED TO ATTEMPT TO GAIN DISTAL SEAL IN A NON MD STENT GRAFT.  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE WHEN DEPLOYING THE ENDOANCHORS, TWO ENDOANCHORS EMBOLIZED AND TRAVELLED INTO THE AORTIC SAC DURING DEPLOYMENT. THE PHYSICIAN THOUGHT THEY HAD ENGAGED THE AORTIC WALL BUT THEY HAD NOT. THE ENDOANCHORS REMAIN FLOATING IN THE AORTIC SAC.  AS PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13540093 ↗
• InjuryOct 28, 2020Malposition of Device; Malposition of Device

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE ON AN UNKNOWN DATE. IT WAS REPORTED ON AN UNKNOWN DATE MONTHS LATER, A TYPE IA ENDOLEAK OCCURRED. INTERVENTION WAS PERFORMED WHERE A TOTAL OF 8 ENDOANCHORS WERE IMPLANTED OF WHICH 2 WERE SAID TO BE NOT OPTIMALLY PLACED DUE TO THE PHYSICIAN BEING A 1ST TIME USER OF THE ENDOANCHORING SYSTEM & THERE BEING TIME PRESSURE DUE TO CARDIAC EVENTS THAT OCCURRED IN THE PROCEDURE. THE PATIENT SUFFERED FROM AN AIR EMBOLISM IN THE AORTIC ARCH AND WAS SAID TO BE STABLE BY THE END OF THE PROCEDURE. THE NEXT MORNING THE PATIENT AWOKE WITH A STROKE. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Embolism; Embolism/Embolus; Stroke/CVA

  MAUDE report 10746507 ↗
• InjuryDec 3, 2019Difficult to Insert; Malposition of Device; Device Dislodged or Dislocated; Difficult to Insert; Malposition of Device; Device Dislodged or Dislocated

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM OF UNKNOWN SIZE. IT WAS REPORTED THAT APPROXIMATELY 2 YEARS 8 MONTHS POST INDEX PROCEDURE, DUE TO DISTAL AORTIC DILATION A VALIANT NAVION STENT GRAFT WAS IMPLANTED AS AN EXTENSION. THE PHYSICIAN ELECTED TO IMPLANT ENDOANCHORS DUE TO A POSSIBLE TYPE IA ENDOLEAK OBSERVED AT THE VERY PROXIMAL MARGIN HOWEVER IT WAS NOTED THAT THE ENDOLEAK DID NOT APPEAR TO BE FILLING THE SAC. THE ENDOANCHORS WERE PLANNED TO BE PLACED ALONG THE LESSER CURVE OF THE AORTA AT THE PROXIMAL MARGIN OF THE PRIOR VALIANT CAPTIVIA IMPLANT DISTAL TO THE LCC/LSA. DURING PLACEMENT OF THE ENDOANCHOR, IT WAS INITIALLY DEPLOYED AND PENETRATED THE FABRIC. THE SECOND PHASE OF DEPLOYMENT WAS PERFORMED BUT THE ENDOANCHOR DISLODGED AND REMAINED SUSPENDED IN THE ARCH FOR A FEW SECONDS BEFORE DISAPPEARING INTO THE RCC OR LCC. 8 ADDITIONAL ENDOANCHORS WERE PLACED IN TOTAL, 7 SUCCESSFULLY AS PLANNED. THE 6TH ENDOANCHOR WAS NOT DEPLOYED SUCCESSFULLY. AS PER THE PHYSICIAN, THE CAUSE WAS PRODUCT RELATED. THE CAUSE OF THE TYPE IA ENDOLEAK WAS NOT CONFIRMED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9401322 ↗

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