Heli-FX™ EndoAnchor™ System SG-64 (UDI 00763000225964)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00763000225964), received between Mar 27, 2020 and May 11, 2023 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (10 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2023Leak/Splash; Leak/Splash

  A HELI-FX ENDOANCHORING SYSTEM WAS USED PROPHYLACTICALLY WITH A MEDTRONIC STENT GRAFT.  IT WAS REPORTED THAT DURING THE PROCEDURE, HELI-FX ENDOANCHORS WERE BEING IMPLANTED IN THE PATIENTS PROXIMAL NECK. DURING THE DEPLOYMENT PROCESS , THERE APPEARED TO BE AIR IN THE PATIENTS LEFT ILIAC LIMB. THE PHYSICIAN WAS NOT SURE AT WHAT POINT DURING THE DEPLOYMENT OF SIX ENDOANCHORS, THE AIR WAS INTRODUCED . THE PHYSICIAN  THEN REVIEWED THE FINAL ANGIOGRAM THAT HAD BEEN PERFORMED PRIOR TO THE PLACEMENT OF THE ENDOANCHORS AND NO AIR WAS PRESENT.  THEREFORE, THE PHYSICIAN  BELIEVES EITHER THE GUIDE OR APPLIER INTRODUCED THE AIR. IT WAS SAID PRIOR TO THE DEVICE INSERTION, THE SCRUB TECHNICIANS PRESENT WERE INFORMED OF THE CORRECT FLUSHING TECHNIQUE FOR THE HELI-FX.  THE PHYSICIAN WAS THEN ABLE TO REMOVE THE AIR BY ADVANCING A SHEATH JUST UNDER THE AIR AND ASPIRATING IT. THIS WAS SUCCESSFUL AND NO FURTHER AIR WAS NOTED.  PER THE PHYSICIAN THE CAUSE OF THE EVENT IS PRODUCT RELATED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Air Embolism

  MAUDE report 16910227 ↗
• MalfunctionSep 13, 2022Component Missing; Component Missing

  A HELI-FX ENDOANCHORING SYSTEM WAS INTENDED TO BE IMPLANTED PROPHYLACTICALLY IN AN ENDURANT STENT GRAFT. IT WAS REPORTED DURING THE INDEX PROCEDURE, WHEN THE DEVICE WAS OPENED THE INTRODUCER WAS MISSING. THE PHYSICIAN  ASKED FOR ANOTHER DEVICE TO BE OPENED IN ORDER TO GET ANOTHER INTRODUCER TO IMPLANT THE ENDOANCHORS INTO THE STENT GRAFT AND COMPLETE THE PROCEDURE. PER THE PHYSICIAN THE REASON THE COMPONENT WAS MISSING IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410933 ↗
• MalfunctionJul 18, 2022Component Missing; Component Missing

  A HELI-FX GUIDE WAS INTENDED TO BE USED PROPHYLACTICALLY WITH AN ENDURANT DEVICE DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED DURING THE INDEX PROCEDURE IT WAS NOTED THAT THE DILATOR FOR THE HELI-FX GUIDE WAS MISSING FROM THE PACKAGING. THE PHYSICIAN USED ANOTHER DEFLECTABLE GUIDE IN ORDER TO COMPLETE THE CASE. NO CAUSE FOR THE MISSING DILATOR WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15039789 ↗
• MalfunctionJun 1, 2022Device Damaged by Another Device; Device Damaged by Another Device

  A HELI-FX GUIDE WAS USED DURING THE IMPLANTATION OF A NON-MDT STENT GRAFT INTO AN INTERNAL ILIAC ARTERY.  IT WAS REPORTED DURING THE INDEX PROCEDURE WHEN THE PHYSICIAN WAS USING THE HELI-FX GUIDE TO DELIVER THE 8X80 NON-MEDTRONIC STENT FOR DEPLOYMENT THE STENT GRAFT COULD NOT CROSS THE LESION DUE TO STENOSIS AND/OR VESSEL TORTUOSITY AND NEEDED TO BE REMOVED. UPON RETRACTION, IT WAS NOTED THE STENT WAS NO LONGER ON THE BALLOON CATHETER AND WAS LEFT IN THE PATIENT UNDEPLOYED. IT WAS CONFIRMED THAT THE HELI-FX GUIDE WAS USED OFF LABEL WHEN ATTEMPTING TO DELIVER THE NON-MEDTRONIC STENT. IT IS UNKNOWN IF THE INTERACTION BETWEEN THE HELI-FX GUIDE AND THE NON-MDT STENT AND BALLOON CATHETER RESULTED IN THE REPORTED STENT DISLODGEMENT. NO CAUSE AS PER THE PHYSICIAN WAS PROVIDED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 14564648 ↗
• MalfunctionMay 5, 2022Difficult to Insert; Device Contamination with Chemical or Other Material; Difficult to Insert; Device Contamination with Chemical or Other Material

  A HELI -FX GUIDE WAS USED PROPHYLACTICALLY WITH AN ENDURANT STENT GRAFT DUE TO A SHORT AND ANGLED AORTIC NECK IN AN EVAR PROCEDURE . IT WAS REPORTED DURING THE INDEX PROCEDURE, THE HELI-FX GUIDE WAS PLACED INTO THE PATIENT AND THE DILATOR WAS REMOVED. THE APPLIER WAS INSERTED INTO THE GUIDE AND THE DEVICE WAS ANGLED INTO PLACE. AN ATTEMPT TO ADVANCE THE APPLIER TO TOUCH THE OUTER WALL OF THE GRAFT WAS COMPLETED BUT THE APPLIER WAS UNABLE TO COME OUT OF THE END OF THE GUIDE. UPON EXAMINATION AFTER THE DEVICE WAS REMOVED FROM THE PATIENT, THE GUIDE WAS NOTED TO HAVE A PIECE OF FABRIC STUCK IN THE END OF THE DEVICE PREVENTING THE APPLIER TO BE ADVANCED THROUGH THE GUIDE. ANOTHER GUIDE WAS USED TO COMPLETE THE PROCEDURE. THE GUIDE WAS INSPECTED PRIOR TO INSERTION AS WELL AS THE ANCHOR INSPECTED BEFORE INSERTION. THE PIECE OF FABRIC IS BELIEVED TO BE ON THE INSIDE OF THE DEVICE AND NOT FROM THEGRAFT. THE PHYSICIAN WAS UNABLE TO TRY AND REMOVE THE PIECE OF FABRIC WITH FORCEPS SO THAT'S WHEN IT WAS DECIDED TO OPEN A NEW ONE INSTEAD. IT IS NOT BELIEVED THE FABRIC CAME FROM THE MAIN BODY GRAFT THAT WAS DEPLOYED. ITS THOUGHT TO BE FROM THE HELI-FX GUIDE. THERE WAS NO LEAK IN THE GRAFT THAT W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285014 ↗
• MalfunctionJan 27, 2022Component Missing; Component Missing

  A HELI-FX ENDOANCHORING SYSTEM WAS USED PROPHYLACTICALLY WITH AN ENDURANT STENT GRAFT SYSTEM DURING AN EVAR PROCEDURE. IT WAS REPORTED DURING THE INDEX PROCEDURE, AFTER OPENING THE SG-64 THERE WAS NO DILATOR INCLUDED IN THE PACKAGING. THE PHYSICIAN DECIDED TO USE THE SG-64 WITHOUT THE DILATOR BY INTRODUCING A 16FR NON-MDT SHEATH HIGH UP IN THE ENDURANT BODY OF THE STENT GRAFT, TO PREVENT ANY DAMAGE OF THE ARTERIAL WALL OR STENT GRAFT. 9 ENDOANCHORS WERE SUCCESSFULLY PLACED. PER THE PHYSICIAN THE CAUSE WAS DEEMED PRODUCT RELATED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367112 ↗
• MalfunctionOct 14, 2021Use of Device Problem; Use of Device Problem

  A HELI-FX ENDOANCHORING SYSTEM WAS USED PROPHYLACTICALLY WITH A MDT STENT GRAFT.  IT WAS REPORTED THAT IT WAS DISCOVERED AFTER THE EVENT WHEN THE HOSPITAL SENT AN INVOICE TO MEDTRONIC,  THAT THE HELI-FX GUIDE THAT WAS USED IN THE PROCEDURE HAD BEEN EXPIRED.  IT WAS SAID THAT DUE TO EMERGENCIES  THE PROCEDURE DATE HAD BEEN DELAYED. THE TREATMENT WAS PERFORMED SUCCESSFULLY.  AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS USER ERROR.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12630161 ↗
• MalfunctionJun 8, 2021Device Damaged by Another Device; Device Damaged by Another Device

  A HELI-FX ENDOANCHORING SYSTEM WAS ATTEMPTED TO BE IMPLANTED WITH A NON-MEDTRONIC STENT GRAFT DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE APPLIER COULD NOT ADVANCE OUTSIDE OF GUIDE FOLLOWING DEPLOYMENT OF FIRST TWO ENDO ANCHORS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11958115 ↗
• MalfunctionDec 14, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  2 HELI-FX GUIDES WAS INTENDED TO BE USED AS PART OF A EVAR PROCEDURE. IT WAS REPORTED WHEN THE GUIDES WERE UNPACKED, A UNKNOWN WHITE POWDER WAS FOUND COVERING THE CATHETER SHAFTS OF BOTH DEVICES. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS PRODUCT RELATED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11003195 ↗
• MalfunctionDec 8, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  3 HELI-FX GUIDES WERE INTENDED TO BE USED IN AN ENDOVASCULAR PROCEDURE. IT WAS REPORTED WHEN THESE GUIDES WERE TAKEN OUT OF THE PACKAGING, AN UNKNOWN WHITE POWDER WAS PRESENT ALONG THE DISTAL SHAFTS OF ALL THE GUIDES. THE USE OF THESE GUIDES WAS ABANDONED DUE TO THE CONCERN OF THE STERILITY OF THESE DEVICES. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10968325 ↗
• MalfunctionDec 8, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  TWO HELI-FX GUIDES WERE INTENDED TO BE USED IN AN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT WHEN BOTH GUIDES WERE UNPACKED, THE DISTAL SHAFT CATHETER WERE NOTED TO BE COVERED IN AN UNKNOWN WHITE POWDER. THE USE OF THESE GUIDES WAS ABANDONED. AN ALTERNATIVE GUIDE WAS USED TO COMPLETE THE PROCEDURE. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS A PRODUCT RELATED ISSUE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10967630 ↗
• MalfunctionDec 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A HELI- FX GUIDE WAS INTENDED TO BE USED IN AN ENDOVASCULAR TREATMENT. IT WAS REPORTED THE PRODUCT PACKAGE WAS OPENED, THE CATHETER GUIDE WAS COVERED WITH AN UNKNOWN WHITE POWDER. THE USE OF THIS GUIDE WAS THEN ABANDONED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS A PRODUCT RELATED ISSUE. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10959216 ↗
• MalfunctionDec 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A HELI-FX GUIDE WAS INTENDED TO BE USED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS NOTED WHEN THE PHYSICIAN OPENED THE PACKAGING OF THE GUIDE, AN UNKNOWN WHITE POWDER WAS PRESENT ALONG THE CATHETER SHAFT. AN ALTERNATIVE GUIDE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS PRODUCT RELATED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10958734 ↗
• MalfunctionDec 3, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A HELI-FX GUIDE WAS INTENDED TO BE USED IN AN EVAR PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, AN UNIDENTIFIED WHITE POWDER WAS FOUND COVERING THE WHOLE CATHETER BODY (SHAFT) OF THE GUIDE AFTER OPENING THE PACKAGING. THE USE OF THIS GUIDE WAS ABANDONED AND AN ALTERNATIVE GUIDE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS A PRODUCT RELATED ISSUE. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10940861 ↗
• MalfunctionNov 24, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A HELI-FX ENDOANCHORING SYSTEM WAS IMPLANTED PROPHYLACTICALLY IN AN ENDURANT IIS STENT GRAFT SYSTEM IN DURING THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, AFTER OPENING THE PACKAGING OF THE GUIDE WAS OPENED, PART OF THE GUIDE SHAFT WAS FOUND TO BE COVERED WITH UNKNOWN WHITE POWDER. THE PHYSICIAN BELIEVED THIS MAY HAVE AFFECTED THE STERILITY, AND DECIDED TO REPLACE WITH AN ADDITIONAL HELI-FX GUIDE TO COMPLETE THE PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10895955 ↗
• MalfunctionNov 24, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A HELI-FX ENDOANCHORING SYSTEM WAS IMPLANTED PROPHYLACTICALLY IN AN ENDURANT IIS STENT GRAFT SYSTEM DURING THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, AFTER OPENING THE PACKAGING OF THE GUIDE WAS OPENED, PART OF THE GUIDE SHAFT WAS FOUND TO BE COVERED WITH UNKNOWN WHITE POWDER. THE PHYSICIAN BELIEVED THIS MAY HAVE AFFECTED THE STERILITY AND DECIDED TO REPLACE WITH AN ADDITIONAL HELI-FX GUIDE TO COMPLETE THE PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10895856 ↗
• MalfunctionNov 24, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A HELI-FX ENDO-ANCHORING SYSTEM WAS IMPLANTED PROPHYLACTICALLY IN AN ENDURANT IIS STENT GRAFT SYSTEM IN DURING THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, AFTER OPENING THE PACKAGING OF THE GUIDE WAS OPENED, THE MOST DISTAL PART OF THE GUIDE SHAFT WAS FOUND TO BE COVERED WITH UNKNOWN WHITE POWDER. THE POWDER COULD BE WIPED AWAY EASILY BUT THE PHYSICIAN BELIEVED THIS MAY HAVE AFFECTED THE STERILITY AND DECIDED TO REPLACE WITH AN ADDITIONAL HELI-FX GUIDE TO COMPLETE THE PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10894882 ↗
• MalfunctionMar 27, 2020Material Deformation; Material Deformation

  A HELI-FX GUIDE WAS INTENDED TO BE USED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT WHEN THE CUSTOMER UNPACKAGED THE DEVICE, IT WAS NOTED THAT THE PRODUCT WAS KINKED AT THE DISTAL PART. THE CAUSE OF THE EVENT AS PER THE PHYSICIAN IN UNKNOWN. . NO CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9887658 ↗

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