Endurant® II ETBF2816C124ERecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00613994991317), received between Jun 28, 2017 and Jun 9, 2025 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (7 reports).

6 other recalls cover devices cleared under the same FDA submission (P100021); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 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: Insufficient Information

  MAUDE report 22165857 ↗
• InjuryApr 8, 2024Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM AND HELI- FX ENDOANCHORS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN 53MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, AFTER THE MAIN BODY HAD BEEN PUT IN AND THE LIMBS WERE EXTENDED, AND THE ENDOANCHORS WERE IMPLANTED, AN ANGIOGRAM SHOWED A ENDOLEAK OUT OF THE MAIN BODY. IT WAS THOUGHT THAT PERHAPS DURING THE PROCEDURE A GUIDEWIRE HAD POKED A HOLE IN THE MATERIAL. THE ENDOLEAK WAS NOT A TYPE IV BLUSH ENDOLEAK, BUT A DEFINITE TYPE IIIB. IT¿S ORIGIN WAS NOT EXPLAINED OR CLEAR. THE PHYSICIAN ELECTED TO PUT IN AN AORTIC CUFF TO SEE IF THAT WOULD COVER THE FENESTRATION HOWEVER IT WAS NOT SUCCESSFUL, SO THE PHYSICIAN DECIDED TO USE AN AUI TO FULLY RELINE THE GRAFT AND COME DOWN INTO THE RIGHT SIDE. A RIGHT TO LEFT FEM FEM WAS ALSO PERFORMED. THE LEFT LIMB OF THE GRAFT WAS INCLUDED WITH AN NON MDT OCCLUDER PLUG. PER THE PHYSICIAN THE CAUSE OF THE SUSPECTED TYPE IIIB ENDOLEAK WAS DUE TO USER ERROR. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 19059942 ↗
• InjuryMay 31, 2023Malposition of Device; Malposition of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 35MM RIGHT COMMON ILIAC ARTERY ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE ENDURANT II BIFURCATE STENT GRAFT WAS DEPLOYED IN THE FALSE LUMEN OF THE AORTA L EADING TO A SUPRARENAL DISSECTION WHERE A WIRE DISSECTED THE INFRARENAL AORTA UP TO THE SUPRACELIAC AORTA. THE CONTRALATERAL LIMB WAS PLACED IN THE TRUE LUMEN. INTERVENTION WAS PERFORMED AND STENT GRAFTS WERE IMPLANTED. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS USER ERROR. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 17030330 ↗
• MalfunctionJun 2, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A > 50MM ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED THE PATIENT RETURNED FOR A FOLLOW-UP WHERE ANEURYSM ENLARGEMENT AND TYPE II ENDOLEAK WERE OBSERVED. THE PHYSICIAN TREATED THE TYPE II ENDOLEAK WITH COILING AND GLUE. HOWEVER , THE MANIPULATION TO FIX THE TYPE II CAUSED A TYPE III ENDOLEAK ALSO  AS PER THE PHYSICIAN THE CAUSE OF THE TYPE III ENDOLEAK WAS AS A RESULT OF THE COILING TO STOP THE TYPE II ENDOLEAK.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14571977 ↗
• InjuryJan 29, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 78MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED WHEN THE PATIENT RETURNED FOR FOLLOW-UP THAT A TYPE IA ENDOLEAK HAD DEVELOPED. INTERVENTION WAS PERFORMED ON THE SAME DATE, THE ENDURANT STENT GRAFT SYSTEM WAS RELINED. THIS RESOLVED THE EVENT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WAS REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11251085 ↗
• InjuryAug 12, 2020Difficult to Insert; Difficult to Insert

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 65MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, ETBF2816C124E WAS IMPLANTED WITHOUT ISSUE. 3MENSIO CENTERLINE WORK-UP WAS PERFORMED AND IT WAS INDICATED A LOWEST 3RD RENAL TO AORTIC BIFURCATION MEASUREMENT OF 81MM. IT WAS REPORTED THAT THE GATE WAS RELEASED IN AN ANATOMICAL POSITION AND THE GRAFT DEPLOYMENT COMPLETE AND DELIVERY SYSTEM REMOVAL SUCCESSFULLY. IT WAS REPORTED THAT THE PHYSICIAN WAS NOT ABLE TO CANNULATE THE CONTRALATERAL GATE. ATTEMPTS WERE PERFORMED TO ADVANCE CATHETER, WIRE, SNARE AND APPROACH TECHNIQUES WITHOUT SUCCESS. IT WAS REPORTED THAT THE PHYSICIAN NOTED WHILE ATTEMPTING TO ACCESS THAT THE GATE OPENING WAS CLOSE TO THE POSTERIOR PORTION OF THE ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN THEN DECIDED TO USE ETUF2814C102E, WHICH WAS SUCCESSFULLY PLACED TO THE FEM-FEM AND LEFT ILIAC PLUG. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury

  MAUDE report 10395213 ↗
• InjuryDec 3, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 54 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK LENGTH WAS 10 MM, AND THE NECK DIAMETER RANGED FROM 23-25 MM. MILD PROXIMAL NECK CALCIFICATION AND THROMBUS WAS PRESENT. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, A TYPE IA ENDOLEAK WAS OBSERVED ON THE COMPLETION ANGIOGRAM. THE PHYSICIAN CARRIED OUT ANOTHER PROXIMAL BALLOON INFLATION, HOWEVER THE TYPE IA ENDOLEAK PERSISTED. THE PHYSICIAN WAS SATISFIED WITH THE PROXIMAL POSITION OF THE STENT GRAFT, AND SO THEY ELECTED TO IMPLANT HELI-FX ENDOANCHORS IN THE PROXIMAL NECK TO TREAT THE ENDOLEAK. 6 ENDOANCHORS WERE IMPLANTED, HOWEVER THE TYPE IA ENDOLEAK WAS OBSERVED AGAIN ON ANOTHER ANGIOGRAM. THE PHYSICIAN THEN ELECTED TO COMPLETE THE PROCEDURE AND FOLLOW UP ON A LATER DATE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9402792 ↗
• InjuryMar 22, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 6 YEARS POST THE INDEX PROCEDURE A CT WAS PERFORMED SHOWING A TYPE IA ENDOLEAK. IT IS NOTED THAT THE PATIENT HAD DISEASE PROGRESSION WITH NO ENDOVASCULAR TREATMENT OPTION AND THE PHYSICIAN DECIDED TO CONVERT TO OPEN SURGERY AND EXPLANTATION AND THE EVENT WAS RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED; DUE TO THE DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7361049 ↗
• InjuryJun 28, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS CALCIFIED. IT WAS REPORTED THAT A FOLLOW-UP CT SCAN SHOWED THERE WAS TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT HELI-FX ENDOANCHORS AND THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED. THE PHYSICIAN STATED THE CAUSE OF THE EVENT WAS DUE TO ANATOMY, CALCIFIED AORTIC NECK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6674877 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100021. One submission often covers many models, so check the product and lot details in each record.

• Z-0292-2022 · Oct 15, 2021 · Open, Classified
  Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STEN
• Z-0290-2022 · Oct 15, 2021 · Open, Classified
  Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
• Z-0291-2022 · Oct 15, 2021 · Open, Classified
  Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT G
• Z-2136-2021 · Jun 7, 2021 · Open, Classified
  Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aort
• Z-2135-2021 · Jun 7, 2021 · Open, Classified
  Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat i
• Z-1543-2017 · Feb 27, 2017 · Terminated
  Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E ETBF2513C166E ETBF2313C166E ETBF2316C166