ENDURANT® ENBF2513C166ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994762252), received between May 19, 2017 and Sep 27, 2022 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2022Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED BY THE PATIENT THROUGH TECHNICAL SERVICES, THAT THE PATIENT HAD A PROCEDURE, WHERE AN ENDURANT LIMB WAS IMPLANTED DUE TO AN UNKNOWN ENDOLEAK. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15493834 ↗
• MalfunctionMar 8, 2022Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATED STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM IT WAS REPORTED THE THE PATIENT RETURNED FOR A FOLLOW-UP AND A CT SHOWED THE PRESENCE OF TYPE IA AND TYPE IB ENDOLEAKS.  NO CAUSE OF THE ENDOLEAKS AS PER THE PHYSICIAN WAS PROVIDED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693512 ↗
• InjuryApr 30, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 58MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A TYPE IB ENDOLEAK WAS OBSERVED ON THE LEFT IPSILATERAL SIDE AND RIGHT CONTRALATERAL SIDE FOLLOWING EXAMINATION OF A CT SCAN. THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 7472029 ↗
• InjuryNov 10, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 59MM DIAMETER ABDOMINAL AORTIC ANEURYSM. HOWEVER, IT WAS REPORTED THAT, APPROXIMATELY 6 YEARS AND 8 MONTHS POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN. A CT WAS PERFORMED AND SHOWED A TYPE IA ENDOLEAK WITH A CONTAINED RUPTURE/BULGE BY THE RENAL ARTERIES, AWAY FROM THE STENT GRAFT. THE PHYSICIAN DECIDED TO TREAT THE EVENT USING TWO 32X32X49 ENDURANT AORTIC CUFFS PLACED DISTAL TO THE SMA, COVERING THE RENAL ARTERIES AND INTO THE MAIN BODY OF THE PREVIOUS STENT GRAFT TO SOLVE THE ENDOLEAK. THE ENDOLEAK WAS NOT RESOLVED AND THE PHYSICIAN ELECTED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INTERVENTION. IT WAS REPORTED THAT, A FOLLOW UP CT PERFORMED 2 DAYS POST RE-INTERVENTION REVEALED THAT THE ENDOLEAK HAD SELF-RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO THE PATIENT'S ANATOMY WITH THE BULGE IN THE PATIENTS ABDOMINAL AORTIC NECK PREVENTING THE GRAFT FROM OPPOSING TO THE AORTIC WALL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain; Rupture

  MAUDE report 7016899 ↗
• DeathMay 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS IN HOSPICE CARE AT THE TIME OF DEATH AFTER EXPERIENCING SEVERAL FALLS, FRACTURED SHOULDER, UTI'S, C. DIFF COLITIS, ATRIAL FIBRILATION, RENAL FAILURE, AND HEART FAILURE ALL WITHIN THE 4.5 MONTHS PRIOR TO DEATH. THE CAUSE OF DEATH WAS DETERMINED TO BE DUE TO CONGESTIVE HEART FAILURE AND RENAL FAILURE.

  Patient problems: Death

  MAUDE report 6578561 ↗

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-0290-2022 · Oct 15, 2021 · Open, Classified
  Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
• 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-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-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
• 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