Endurant® II ETBF2513C145ERecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00613994991232), received between Mar 21, 2017 and Mar 18, 2025 — classified as 1 death, 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (5 reports).

1 FDA recall record name this device's identifier.

5 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 18, 2026.

Recalls naming this device

1. Feb 27, 2017Class IITerminated

   Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific models and serial numbers as this specific subset of stent grafts has greater susceptibility to fabric permeability variations that may be associated with endoleaks observed during the initial implant procedure.

   Z-1543-2017 · Root cause: Packaging change control · Recall details · FDA record ↗

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.

• DeathMar 18, 2025Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A RUPTURED AAA. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY 11 YEARS POST-INDEX PROCEDURE WITH A RUPTURED ANEURYSM. THE PHYSICIAN CONVERTED TO OPEN REPAIR. THE STENT GRAFTS WERE EXPLANTED AND AN AORTA BIFEMORAL BYPASS GRAFT WAS IMPLANTED. THE PHYSICIAN COULD NOT IDENTIFY ANY POSSIBLE LEAK SOURCE DUE TO EXCESSIVE BLEEDING BUT IT WAS CONFIRMED AN ENDOLEAK WAS SUSPECTED TO BE THE CAUSE OF THE RUPTURE. IT WAS UNCLEAR THE EXACT TYPE BUT IT WAS REPORTED THAT A TYPE II ENDOLEAK WAS MOST LIKELY. THE PATIENT PASSED AWAY TWO DAYS LATER.

  Patient problems: Rupture

  MAUDE report 21629850 ↗
• InjuryMar 11, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A EVAR PROCEDURE WAS PERFORMED TO TREAT A 60MM AAA . DURING FOLLOW-UP A TYPE III ENDOLEAK WAS NOTED IN THE ENDURANT II BIFURCATE. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS ANATOMY AND A POSSIBLE DEVICE ISSUE AT THE FLOW DIVIDER.

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

  MAUDE report 21571356 ↗
• InjuryJun 14, 2022Leak/Splash; Device Damaged by Another Device; Leak/Splash; Device Damaged by Another Device

  AN ENDURANT II BIFURCATED STENT GRAFT WAS IMPLANTED FOR THE TREATMENT OF A 56MM ABDOMINAL AORTIC ANEURYSM WITH A SHORT NECK. IT WAS REPORTED DURING THE INDEX PROCEDURE THAT THE LEFT RENAL ARTERY WAS STENTED PRE GRAFT PLACEMENT AND THE ANGLE OF THE RENAL ARTERY CHANGED DRAMATICALLY. THE PHYSICIAN THEN ELECTED TO LAND THE GRAFT INFRA RENAL. THE MAIN BODY AND CONTRALATERAL LIMB WERE IMPLANTED SUCCESSFULLY. THE FINAL ANGIOGRAM SHOWED A PROXIMAL TYPE IA ENDOLEAK. BALLOONING WAS PERFORMED BUT THE TYPE IA ENDOLEAK PERSISTED. THE PHYSICIAN ATTEMPTED TO IMPLANT HELI-FX ENDOANCHORS TO TREAT THE ENDOLEAK AND NOTED THAT THE APPLIER SOUNDED REALLY SLOW AND DIFFERENT THAN NORMAL. DURING THE SECOND STAGE OF DEPLOYMENT, THE APPLIER DID NOT FULLY RELEASE ALL THE WAY AND CLICKED AT THE END OF DEPLOYMENT. THE PHYSICIAN TRIED TO PULL THE APPLIER BACK BUT IT WAS STUCK ON THE ENDOANCHOR. ONCE IT WAS RELEASED, SIX ADDITIONAL ENDOANCHORS WERE THEN PLACED, BUT THE APPLIER STILL CONTINUED TO SOUND SLOW. A FINAL ANGIOGRAM WAS PERFORMED AND THE TYPE IA ENDOLEAK REMAINED. BALLOONING WAS CARRIED OUT BUT THE PHYSICIAN DECIDED TO FINISH THE PROCEDURE AND WILL MONITOR THE PATIENT. AS PER THE PHYSICIAN, THE CAUSE O

  Patient problems: Insufficient Information

  MAUDE report 14684847 ↗
• MalfunctionSep 23, 2021Material Deformation; Material Deformation

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55MM X 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE FOLLOW UP CT SHOWED A RIGHT LIMB COMPRESSION WITH FLOW VISUALIZED. THE OTHER ENDURANT LIMB ETLW1616C124E (V29560141) IS CONFIRMED AS WIDELY PATENT. SAC REGRESSION FROM PRE IMPLANT (55MM X 50MM) TO 28MM X 50MM WAS ALSO NOTED. PER THE PHYSICIAN THE CAUSE OF THE RIGHT LIMB COMPRESSION IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12518874 ↗
• InjuryJun 17, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT TECHNICAL SERVICES RECEIVED A CALL TO STATE THAT THE STENT GRAFT WERE EXPLANTED BECAUSE THEY DID NOT WORK WELL WHEN IMPLANTED IN THE CALLERS SPOUSE. IT WAS NOTED THAT THE PATIENT ALMOST EXPIRED DUE TO THE STENT GRAFT. THE CAUSE OF THE EVENT WAS NOT PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED.

  Patient problems: Aneurysm; Insufficient Information

  MAUDE report 12017202 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 62MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED ON THE DATE OF A CT, JUST OVER FOUR YEARS LATER , THAT IT WAS NOTED THERE WAS ANEURYSM ENLARGEMENT WITHOUT AN APPARENT ENDOLEAK. TWELVE DAYS LATER, INTERVENTION WAS PERFORMED AND IT WAS THOUGHT THERE WAS AN ENDOLEAK POSSIBLY COMING FROM THE RIGHT ILIAC ETLW1628C124E LIMB. THE PHYSICIAN EXTENDED THIS LIMB WITH A NON MDT ILIAC LIMB. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm

  MAUDE report 10458867 ↗
• InjuryOct 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 57MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED ONE WEEK POST THE INDEX PROCEDURE WITH AN OCCLUDED LIMB EXTENDING INTO THE BIFURCATE WAS OBSERVED ON CT. NO KINKING OR GRAFT MALFUNCTION WAS NOTED. THE PATIENT RECEIVED A FEMORAL-FEMORAL BYPASS. THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Occlusion

  MAUDE report 7938061 ↗
• InjuryNov 9, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF UNKNOWN SIZE. IT WAS REPORTED THAT DURING A FOLLOW UP CT PERFORMED APPROXIMATELY 3.5 YEARS POST INDEX PROCEDURE, OCCLUSION OF THE RIGHT LIMB OF THE STENT GRAFT WAS OBSERVED. IT WAS STATED THAT THE PATIENT HAD REPORTED PAIN IN HIS RIGHT LEG FROM APPROXIMATELY 3 YEARS POST INDEX PROCEDURE WHICH THE PHYSICIAN STATES TO BE LIKELY RELATED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS RELATED TO ANGULATION OF THE AORTA, CAUSING THROMBOSIS OF THE LIMB TO OCCUR. IT WAS REPORTED THAT THERE WAS NO INTERVENTION PERFORMED AT TIME OF EVENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED BY THEIR PHYSICIAN.

  Patient problems: Occlusion; Pain

  MAUDE report 7012510 ↗
• InjuryMar 21, 2017Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.7 CM ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK MEASURES FROM 20-23MM IN DIAMETER AND 15MM AORTIC NECK LENGTH. IT WAS REPORTED THAT DURING DEPLOYMENT OF THE MAIN BODY, THE STENT GRAFT MOVED DOWN LOWER THAN THE PHYSICIAN INTENDED, RESULTING IN A TYPE IA ENDOLEAK. A 25X25 CUFF WAS IMPLANTED AND THE EVENT RESOLVED WITH PROPER PROXIMAL SEAL. THE PHYSICIAN STATED THAT THE DELIVERY SYSTEM AND THE STENT GRAFT MUST HAVE MOVED DOWN DUE TO USER ERROR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6421701 ↗

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-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-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-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 infra
• 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 aortoili