Heli-FX EndoAnchor SystemRecalls & reported problems across all models

We found 13 models of Heli-FX EndoAnchor System by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 191 adverse event reports in the FDA's MAUDE database, received between Sep 22, 2017 and Aug 12, 2026 — classified as 17 deaths, 73 injuries, 101 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (92 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Heli-FX EndoAnchor System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 13, 2017Terminated

   It was determined that the deflection length indicated on the Guide catheter handle does not match the label on the box and sterile packaging for two lots.

   Z-3227-2017 · Root cause: Labeling Change Control · names 2 of these models · Recall details · FDA record ↗

Most reported Heli-FX EndoAnchor System problems

Heli-FX EndoAnchor System models

13 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Heli-FX™ EndoAnchor™ System SA-85

  Endovascular suturing system
  6 deaths70 reports
• Heli-FX™ EndoAnchor™ System HG-18-90-22

  Endovascular suturing system
  1 recall1 report
• Heli-FX™ EndoAnchor™ System HG-18-90-42

  Endovascular suturing system
  1 recall0 reports
• Heli-FX™ EndoAnchor™ System SA-85

  Endovascular suturing system
  4 deaths44 reports
• Heli-FX™ EndoAnchor™ System SA-85

  Endovascular suturing system
  6 deaths41 reports
• Heli-FX™ EndoAnchor™ System SG-64

  Endovascular suturing system
  18 reports
• Heli-FX™ EndoAnchor™ System HG-16-62-28

  Endovascular suturing system
  5 reports
• Heli-FX™ EndoAnchor™ System HA-18-114

  Endovascular suturing system
  1 death4 reports
• Heli-FX™ EndoAnchor™ System HG-18-90-32

  Endovascular suturing system
  3 reports
• Heli-FX™ EndoAnchor™ System HG-16-62-28

  Endovascular suturing system
  2 reports
• Heli-FX™ EndoAnchor™ System SG-64

  Endovascular suturing system
  1 report
• Heli-FX™ EndoAnchor™ System HG-18-90-42

  Endovascular suturing system
  1 report
• Heli-FX™ EndoAnchor™ System HG-18-90-42

  Endovascular suturing system
  1 report

Recent Heli-FX EndoAnchor System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218471 ↗
• MalfunctionMay 1, 2026Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT A PATIENT REPRESENTATIVE CONTACTED TECHNICAL SERVICES APPROXIMATELY 14 YEARS LATER AND STATED THAT THE PATIENT EXPERIENCED AN ENDOLEAK THAT WAS REPAIRED 4 MONTHS PREVIOUSLY WITH AN ENDURANT CUFF. SUBSEQUENT INFORMATION RECEIVED CONFIRMED THAT THE ENDOLEAK WAS A TYPE IA INVOLVING THE ENDURANT BIFURCATED GRAFT. THE ENDOLEAK DID NOT RESOLVE FOLLOWING CUFF IMPLANTATION; THEREFORE, SIX ENDOANCHORS WERE PLACED, RESULTING IN A REDUCTION OF THE ENDOLEAK. THE PHYSICIAN LATER CONFIRMED THAT THE ENDOLEAK WAS FULLY RESOLVED ON FOLLOW-UP IMAGING. LACK OF WALL APPOSITION WAS NOTED IN THE LEFT LIMB; HOWEVER, NO TYPE IB ENDOLEAK WAS IDENTIFIED. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE TYPE IA ENDOLEAK WAS PROGRESSIVE DILATION OF THE AORTA SINCE THE INDEX PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25054516 ↗
• MalfunctionApr 24, 2026Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA. 5 WEEKS LATER, STENT GRAFT INFOLDING WAS OBSERVED ON IMAGING. THE SPONSOR ASSESSED THE INFOLDING AS POSSIBLY RELATED TO PROCEDURE AND RELATED TO DEVICE. THE CAUSE WAS UNKNOWN. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24978172 ↗
• InjuryApr 15, 2026Malposition of Device; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INDEX ENDOVASCULAR PROCEDURE TO TREAT A 45 MM ABDOMINAL AORTIC ANEURYSM, AN ENDURANT II/IIS STENT GRAFT SYSTEM (ESBF3214C103E WITH ETLW1616C93E AND ETLW1620C93E) WAS IMPLANTED SUCCESSFULLY AND ENDO-ANCHORS WERE THEN DEPLOYED. FIVE ENDO-ANCHORS WERE IMPLANTED SUCCESSFULLY; HOWEVER, DURING DEPLOYMENT OF THE SIXTH ENDO-ANCHOR, THE ANCHOR WAS REPORTED TO NOT BE ENGAGED WITH THE GRAFT FABRIC OR ARTERIAL WALL WHEN DEPLOYED. THE ENDO-ANCHOR MIGRATED ABOVE THE SUPRARENAL STENTS OF ESBF3214C103E. THE PHYSICIAN REMOVED THE ENDO-ANCHOR DELIVERY SYSTEM, INSERTED THE DILATOR OF A 16 FR SHEATH, AND ADVANCED THE 16 FR SHEATH PROXIMAL TO THE SUPRARENAL STENTS OF ESBF3214C103E OVER A STIFF 0.035-INCH GUIDEWIRE, THEN REMOVED THE DILATOR. A GOOSE-NECK STYLE SNARE WAS INSERTED TO ATTEMPT TO SNARE THE UNFIXED ENDO-ANCHOR. DURING THIS MANEUVER THE 16 FR SHEATH AND SNARE WERE PULLED DOWN INTO THE GRAFT, AFTER WHICH THE SNARE BECAME TANGLED WITH THE SUPRARENAL STENTS OF ESBF3214C103E. THE PHYSICIAN ATTEMPTED UNSUCCESSFULLY TO FREE THE SNARE AND THEN CONVERTED TO AN OPEN SURGICAL REPAIR OF THE ABDOMINAL ANEURYSM. THE ESBF3214C103E, ETLW1616C93E, ETLW1620C93E, AND SA-85 ENDO-A

  Patient problems: Insufficient Information

  MAUDE report 24881348 ↗
• InjuryMar 13, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR AORTIC REPAIR CASE USING THE HELI-FX ENDOSYSTEM PROPHYLACTICALLY WITH A NON MDT ENDO-GRAFT. THE AORTA DIAMETER AT THE RENAL ARTERY WAS 29-30MM AND THE PROXIMAL AORTIC NECK LENGTH WAS 15MM AT IMPLANT. THE VESSEL WAS NOT TORTUOUS AND HAD NO CALCIFICATION AT IMPLANT. IT WAS REPORTED DURING THE INDEX PROCEDURE ONE ENDOANCHOR BECAME DISLODGED FROM THE ENDOGRAFT AND EMBOLIZED INTO THE RIGHT RENAL ARTERY. AN ATTEMPT WAS MADE TO RECOVER THE ENDOANCHOR WITH AN EN-SNARE, BUT THIS WAS UNSUCCESSFUL. THE ENDOANCHOR REMAINS IN THE RENAL ARTERY, AND THE PATIENT HAS NOT RECEIVED ANY FURTHER TREATMENT. A 30-DAY COMPUTED TOMOGRAPHY IS PLANNED TO DETERMINE ANY ADVERSE EVENTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE CAUSE OF THE DISLODGEMENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24589108 ↗
• InjuryMar 9, 2026Misfire; Malposition of Device; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING THE PLACEMENT OF AN ENDOANCHOR USING THE HELI-FX APPLIER, THE APPLIER WOULD NOT DISENGAGE. THE APPLIER WAS ROTATED COUNTERCLOCKWISE IN AN ATTEMPT TO RELEASE THE ANCHOR, WHICH THEN BECAME DISLODGED AND FLOATED TOWARDS THE HEAD. AN ATTEMPT TO SNARE THE DISLODGED ANCHOR WAS UNSUCCESSFUL, AND THE ANCHOR WAS SUBSEQUENTLY LODGED INTO AN INTERCOSTAL ARTERY USING A GASTROINTESTINAL GRASPER. PLACEMENT OF ADDITIONAL ENDOANCHORS WAS RESUMED, BUT THERE WAS DIFFICULTY RELEASING THE ENDOANCHOR DURING THE NEXT ATTEMPT. A NEW APPLIER WAS OPENED AND USED TO SUCCESSFULLY PLACE THE REMAINING ENDOANCHORS WITHOUT FURTHER ISSUES. THE EVENT WAS RESOLVED BY REPLACING THE APPLIER AND COMPLETING THE PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24543688 ↗
• DeathMar 3, 2026Leak/Splash; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED FOR NSTMI AND FLANK PAIN AND WAS BEING TREATED BY CARDIO DUE TO HIS HEART FAILURE HISTORY. DURING ADMISSION A CT SHOWED CHRONIC AORTIC DISSECTION WITH ASCENDING ENDOLEAK. VASCULAR SURGERY WAS CONSULTED AND NO ACUTE INTERVENTION WAS RECOMMENDED WITH PLANS FOR ELECTIVE SURGERY IN 1 MONTH. DURING HOSPITALIZATION THE PATIENT DEVELOPED ACUTE UNRESPONSIVENESS REQUIRING EMERGENT INTUBATION. THE PATIENT SUFFERED AN ACUTE INFARCT IN THE RIGHT OCCIPITAL LOBE AND A CHRONIC INFARCT IN THE LEFT PARIETAL LOBE AND WAS TREATED WITH THROMBOLYTIC THERAPY FOLLOWED BY SUCCESSFUL MECHANICAL THROMBECTOMY. THE POST-PROCEDURE COURSE WAS COMPLICATED BY EPISTAXIS AND OROPHARYNGEAL AND GROIN ACCESS BLEEDING, SUSPECTED TO BE THROMBOLYTIC-INDUCED DISSEMINATED INTRAVASCULAR COAGULATION. SIX HOUR POST THROMBECTOMY HEAD CT SHOWED R P-O EVOLVING INFARCT WITH HAEMORRHAGIC CONVERSION IN THE STROKE BED AND CONTRAST STAINING. DUE TO DIC, PATIENT DEVELOPED A DISTRIBUTIVE SHOCK. THIS RESULTED IN ACUTE KIDNEY INJURY. THE PATIENT SUFFERED WITH PERSISTENT FEVERS AND LEUKOCYTOSIS, LIKELY RELATED TO WORSENING ASCENDING DISSECTION WITH EN

  Patient problems: Aortic dissection; Disseminated Intravascular Coagulation (DIC); Fever; Hemorrhage/Blood Loss/Bleeding; Hemothorax; Myocardial Infarction; Pain; Pneumonia; Renal Failure; Shock; Stroke/CVA; Unspecified Infection; Vascular Dissection

  MAUDE report 24497319 ↗
• MalfunctionDec 19, 2025Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING USE OF A HELI-FX ENDOANCHOR SYSTEM, THE END OF THE ENDOANCHOR BROKE OFF INSIDE THE APPLIER AND WAS SUBSEQUENTLY REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847677 ↗
• MalfunctionOct 24, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE FOR TREATMENT OF A 57MM ANEURYSM, THE STENT GRAFT ESBF3614C103E ENDUR IIS BIF WAS IMPLANTED IN THE ABDOMINAL AORTA. A COMPLETION ANGIOGRAM IDENTIFIED A TYPE 1A ENDOLEAK, ALTHOUGH THE POSITION OF THE PROXIMAL GRAFT EDGE WAS OPTIMAL AND ENDOANCHORS WERE PLACED IN THE DESIRED LOCATIONS. NO ADDITIONAL STEPS WERE TAKEN AT THE TIME, AND FOLLOW-UP IMAGING WAS PLANNED IN 30 DAYS TO FURTHER EVALUATE THE SITUATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PER THE PHYSICIAN THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377251 ↗
• DeathOct 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA .ENDOANCHORS WERE ALSO IMPLANTED DUE TO A AORTIC CONICAL NECK. IT WAS REPORTED THE PATIENT PRESENTED UNDER THREE MONTHS LATER AND THE STENT GRAFTS WERE EXPLANTED THE FOLLOWING DAY DUE TO AN INFECTED GRAFT. THE PHYSICIAN NOTED THERE WAS PUS SURROUNDING THE GRAFT UPON EXPLANT. THE PATIENT PASSED AWAY ON THE SAME DATE. NO CAUSE OF THE INFECTION OR THE PATIENT DEATH WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 23190503 ↗
• MalfunctionJun 9, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE INVOLVING THE STENT GRAFT ETBF2816C124E ENDUR II BIF, A LARGE ENDOLEAK WAS OBSERVED AFTER FULL DEPLOYMENT OF THE DEVICE. THE PATIENT WAS TREATED FOR A 42MM SACCULAR ANEURYSM WITH ENDOVASCULAR AORTIC REPAIR AND ESAR.IT WAS STATED THAT ENDOANCHORS WERE PLACED AFTER THE ENDOLEAK WAS OBSERVED TO RULE OUT A TYPE IA ENDOLEAK. DURING THE INVESTIGATION OF THE ENDOLEAK, THERE WAS A POSSIBILITY OF A TEAR OR HOLE IN THE ENDOGRAFT. PATIENT LEFT THE OPERATING ROOM WITH WHAT WAS THOUGHT TO BE A TYPE IIIB ENDOLEAK. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE PATIENT WILL BE MONITORED. A 30 DAY FOLLOW UP IS PLANNED TO CONFIRM THE ENDOLEAK TYPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165860 ↗
• MalfunctionJun 9, 2025Fracture; Misfire; Device Damaged by Another Device; Fracture; Misfire; Device Damaged by Another Device

  A HELI-FX ENDOANCHORING SYSTEM WAS USED TO AID THE DISTAL FIXATION OF A NON MDT FENESTRATED STENT GRAFT. THE FIRST ENDOANCHOR WAS LOADED AND THEN THE APPLIER INSERTED INTO PATIENT. THE DESIRED POSITION WAS ACHIEVED AND THE FIRST STAGE OF DEPLOYMENT COMPLETED. THE PHYSICIAN WAS HAPPY WITH THE POSITION SO THE SECOND STAGE OF DEPLOYMENT WAS COMMENCED. DURING THE DEPLOYMENT, THE CATHETER TORQUED DOWN AND JUMPED FORWARD. IT WAS THOUGHT IT CAUGHT ON THE STENT GRAFT AND PART OF THE ENDOANCHOR DEPLOYED. WHEN REMOVING THE APPLIER, A SMALL PIECE OF METAL WHICH WAS BELIEVED TO BE THE FOOTPLATE OF THE ENDOANCHOR WAS NOTICED. ANOTHER APPLIER WAS USED TO CONTINUE THE CASE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165312 ↗
• DeathApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INDEX PROCEDURE INVOLVING THE HELI-FX ENDOSYSTEM AND A N ENDURANT IIS, A RUPTURE WAS SUSPECTED WHEN THE NON-MEDTRONIC WIRE APPEARED TO DEFLECT OUTSIDE THE AORTIC LUMEN UPON REMOVAL OF THE HELI-FX GUIDE. PRE-OPERATIVELY THE DIAMETER OF THE AORTA AT THE RENAL ARTERY MEASURED 26MM WHILE THE LENGTH OF THE PROXIMAL AORTIC NECK WAS 9MM. MODERATE VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION WERE REPORTED. THE PROCEDURE INITIALLY INVOLVED THE SUCCESSFUL PLACEMENT OF A 32MM BIFURCATED DEVICE AND 16X16MM DIAMETER LIMBS, ALONG WITH SIX ENDOANCHORS DUE TO THE PATIENT'S SHORT AND CONICAL NECK ANATOMY. A SELECTIVE ANGIOGRAM WAS PERFORMED, AND NO RUPTURE LEAKS WERE IDENTIFIED AT THAT TIME. HOWEVER, APPROXIMATELY ONE HOUR LATER, THE PATIENT WAS REPORTED TO BE UNSTABLE, PROMPTING ANOTHER ANGIOGRAM WHICH REVEALED A TEAR ABOVE THE LEFT RENAL ARTERY. THE LEFT RENAL ARTERY WAS EMBOLIZED VIA BRACHIAL APPROACH AND COVERED WITH A 32X32X49MM AORTIC CUFF, WHILE THE RIGHT RENAL ARTERY WAS STENTED AND "SNORKELED" BEHIND A 36X36X49MM AORTIC CUFF, MAINTAINING BLOOD FLOW THROUGH THE STENT. THE PATIENT RECEIVED THREE UNITS OF BLOOD AND WAS TRANSFERRED TO CRITICAL CARE. MULTIPLE

  Patient problems: Stroke/CVA

  MAUDE report 21760743 ↗
• MalfunctionMar 31, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT DURING A PROPHYLACTIC PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM, A MALFUNCTION OCCURRED WITH A HELI-FX AP PLIER. AFTER SUCCESSFULLY IMPLANTING THREE ENDOANCHORS, THE FOURTH ENDOANCHOR FAILED TO LOAD FULLY INTO THE APPLIER WAS STICKING OUT. THE PHYSICIAN FOLLOWED THE INSTRUCTIONS FOR USE USING THE HELI-FX APPLIER. WHEN AN ATTEMPT WAS MADE TO LOAD ANOTHER ENDOANCHOR, THE SAME ISSUE OCCURRED. TO RESOLVE THE ISSUE, ANOTHER APPLIER WAS OPENED AND USED TO COMPLETE THE SURGERY. THE PROCEDURE WAS COMPLETED AS PLANNED WITH THE USE OF THE NEW APPLIER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729094 ↗
• MalfunctionMar 21, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT TREATED FOR AN ANEURYSM WITH A STENT GRAFT ESBF2514C103E ENDUR IIS BIF EXPERIENCED AN APPARENT TYPE IA ENDOLEAK. THE EVENT WAS DISCOVERED ON THE DATE OF A CT SCAN. NO PRE-OPERATIVE ANEURYSM RUPTURE WAS NOTED. THE PHYSICIAN CONFIRMED THAT THE TYPE IA ENDOLEAK WAS CAUSED BY VESSEL TORTUOSITY. INTERVENTION WAS PERFORMED, DURING WHICH THE PHYSICIAN BALLOONED THE VESSEL, PLACED ENDOANCHORS, AND DEPLOYED A NON-MDT STENT, RESULTING IN NEAR-COMPLETE RESOLUTION OF THE ENDOLEAK. THERE WAS A VERY FAINT ENDOLEAK VISIBLE AT THE END OF THE INTERVENTION. THE PHYSICIAN SUSPECTS THIS MAY BE RESOLVED WITH HEPARIN REVERSAL. A FOLLOW-UP EVALUATION IS PLANNED IN 30 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21661681 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls