ENDURANT® ENBF2813C166ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994762191), received between Jan 9, 2019 and Apr 23, 2021 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Leak/Splash” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathApr 23, 2021Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE AAA. UNDER 10 YEARS LATER, THE PATIENT PRESENTED WITH LOSS OF LEFT LEG MOTOR FUNCTION. IT WAS ALSO REPORTED THERE WAS STENT GRAFT SEPARATION. A CT REVEALED ACUTE LIMB ISCHEMIA. AN OPEN EXPLANT WITH AN AORTA BILATERAL FEMORAL BYPASS PROCEDURE WAS PERFORMED THE FOLLOWING DAY. ONE DAY POST THE INTERVENTION IT WAS REPORTED THE PATIENT DIED DUE TO RENAL FAILURE. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ACUTE LIMB ISCHEMIA. THE CAUSE OF THE PATIENT DEATH WAS RENAL FAILURE AND NOT BEING ABLE TO TOLERATE THE SURGICAL INTERVENTION. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT HAS EXPIRED.

  Patient problems: Ischemia; Renal Failure

  MAUDE report 11716141 ↗
• InjuryJan 9, 2019Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE WITH ABDOMINAL PAIN. A CT SHOWED A 9CM ABDOMINAL ANEURYSMS AND IT WAS NOTED THAT THE ENDURANT LIMBS HAD PULLED UP INTO THE ANEURYSM SAC AND A TYPE IB ENDOLEAK WAS PRESENT. THE PATIENT WAS TREATED WITH LIMBS EXTENDING DOWN INTO THE HYPOGASTRIC ARTERIES BILATERALLY AND NO ENDOLEAK WAS OBSERVED ON FINAL ANGIOGRAM. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO TORTUOUS ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8230635 ↗

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-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-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-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