Heli-FX™ EndoAnchor™ System HA-18-114 (UDI 00763000006648)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000006648), received between Nov 23, 2017 and Oct 24, 2019 — classified as 1 death, 2 injuries, 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, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HELI-FX ENDOANCHORS WERE IMPLANTED PROPHYLACTICALLY IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 45 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. A NON-MEDTRONIC STENT GRAFT SYSTEM WAS IMPLANTED ON THE SAME DAY. IT WAS REPORTED THAT A LYMPHOCELE WAS OBSERVED APPROXIMATELY 8 DAYS POST INDEX PROCEDURE. THE PATIENT WAS TREATED WITH INCISIONAL DEBRIDEMENT AND THE EVENT WAS RESOLVED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE STUDY DEVICES OR PROCEDURE. THE SPONSOR ASSESSED THE EVENT AS PROBABLY RELATED TO THE STUDY PROCEDURE, NOT RELATED TO THE STUDY DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Cyst(s)

  MAUDE report 9232715 ↗
• InjuryOct 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HELI-FX ENDOANCHORS WERE IMPLANTED PROPHYLACTICALLY IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 45 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. A NON-MEDTRONIC STENT GRAFT SYSTEM WAS IMPLANTED ON THE SAME DAY. IT WAS REPORTED THAT RIGHT LOWER EXTREMITY ISCHEMIA WAS OBSERVED ON THE DAY OF THE INDEX PROCEDURE. THE PATIENT WAS TREATED WITH A LOWER EXTREMITY ARTERIAL INTERVENTION AND THE EVENT WAS RESOLVED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE STUDY DEVICES OR PROCEDURE. THE SPONSOR ASSESSED THE EVENT AS PROBABLY RELATED TO THE STUDY PROCEDURE, NOT RELATED TO THE STUDY DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Ischemia

  MAUDE report 9232685 ↗
• MalfunctionMay 15, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 56MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS PLANNED THAT HELI-FX ENDOANCHORS WOULD ALSO BE USED PROPHYLACTICALLY IN THE PROCEDURE DUE TO CONCERN OVER A SHORT DISTAL LANDING ZONE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE FIRST VALIANT STENT GRAFT WAS PLACED IN A STRAIGHT SEGMENT OF THE THORACIC AORTA AND DEPLOYED WITHOUT ISSUE. A SECOND VALIANT STENT GRAFT WAS THEN DEPLOYED PROXIMAL TO THE CELIAC TRUNK WITHOUT ISSUE. A RELIANT BALLOON WAS USED TO SEAL THE PROXIMAL, OVERLAP AND DISTAL SEAL ZONES. THEN A TOTAL OF 8 ENDOANCHORS WERE PLACED IN THE DISTAL SEAL ZONE AND AN ANGIOGRAM WAS PREFORMED THAT SHOWED A TYPE IB ENDOLEAK. THE PHYSICIAN RE-BALLOONED THE DISTAL SEAL MORE AGGRESSIVELY AND THIS SHOWED THE TYPE IB ENDOLEAK WAS GREATLY REDUCED. THE PHYSICIAN DECIDED TO END THE PROCEDURE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO THE SHORT DISTAL SEAL ZONE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7514282 ↗
• DeathNov 23, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A HELI-FX APPLIER AND ENDOANCHORS WERE USED PROPHYLACTICALLY AS AN ACCESSORY DEVICE FOR THE ENDOVASCULAR TREATMENT OF THE PATIENT WITH A VALIANT STENT GRAFT SYSTEM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN PLACED THE HELI- FX GUIDE IN THE APPROPRIATE LOCATION TO DEPLOY AN ENDOANCHOR IN THE RIGHT LATERAL WALL OF THE DESCENDING THORACIC AORTA, JUST ABOVE THE CELIAC. AFTER DEPLOYING THE ENDOANCHOR TO THE FIRST STAGE, IT WAS DETERMINED THAT IT WAS IN A GOOD POSITION. WHEN THE ENDOANCHOR WAS FULLY DEPLOYED, IT APPEARED TO "FLOAT" BEHIND THE EXISTING STENT GRAFT AND SETTLED IN THE DESCENDING ANEURYSM SAC BEHIND THE STENT GRAFT. A SECOND ENDOANCHOR WAS THEN PLACED BY THE PHYSICIAN IN A SIMILAR LOCATION AND IT ALSO APPEARED TO "FLOAT" THROUGH THE STENT GRAFT WALL TO A SIMILAR LOCATION. IT WAS NOTED THAT PLACEMENT OF THE ENDOANCHORS IN THE LEFT ASPECT OF THE STENT GRAFT WAS SUCCESSFUL. AS PER THE PHYSICIAN, THE CAUSE OF THE ENDOANCHOR EVENT WAS PRODUCT RELATED. IT WAS REPORTED THAT, 6 DAYS POST INDEX PROCEDURE, THE PATIENT HAD A CARDIAC EVENT DURING ROUTINE EXERCISE WITH THE REGISTERED NURSE AND DIED AFTER CPR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. IT WAS REPO

  Patient problems: Cardiac Arrest; Death; Device Embedded In Tissue or Plaque

  MAUDE report 7056725 ↗

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