ENDURANT® ENEW2424C82ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994762139), received between Jun 27, 2018 and Aug 5, 2020 — classified as 2 injuries.

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.

• InjuryAug 5, 2020Leak/Splash; Leak/Splash

  AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM LOCATED IN THE ILIAC ARTERY. IT WAS REPORTED THAT DURING FOLLOW-UP, APPROXIMATELY 8.5 YEARS POST INDEX PROCEDURE, A CT WAS PERFORMED. IT WAS STATED THAT THE TWO DEVICES IMPLANTED IN THE LEFT ILIAC ARTERY HAD SEPARATED AND A TYPE IIIA ENDOLEAK WAS OBSERVED. IT WAS REPORTED THAT A LIMB WAS IMPLANTED AND THE EVENT WAS RESOLVED. AS PER THE PHYSICIAN, CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 10367399 ↗
• InjuryJun 27, 2018Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 32MM ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2011. THE PROXIMAL NECK DIAMETER WAS NOTED AS 23MM AND 20MM IN LENGTH. A TORTUROUS EXTERNAL ILIAC ARTERY WAS REPORTED AT THE INDEX PROCEDURE. IT WAS REPORTED THAT ON CT COMPLETED APPROXIMATELY 7.5 YEARS POST INDEX PROCEDURE, THE RIGHT ILIAC ARTERY HAD DILATED BEYOND THE SIZE OF THE 24MM IMPLANTED LIMB EXTENSION. INTERVENTION WAS CARRIED OUT WHERE THE RIGHT HYPO GASTRIC ARTERY WAS COILED AND A 16X10 ENDURANT LIMB WAS IMPLANTED INTO THE EXTERNAL ILIAC ARTERY TO SEAL IT. THE EVENT WAS RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED WHERE THE ILIAC ARTERY HAD DILATED OVER TIME. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7641530 ↗

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-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-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