ENDURANT® ENLW1628C124ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994762177), received between May 16, 2017 and Jan 29, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2020Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING A FOLLOW UP CT APPROXIMATELY 9 YEARS POST IMPLANT, IT WAS NOTED THAT THERE WAS A SEPARATION ENDOLEAK BETWEEN THE ENDURANT LIMBS. AN ADDITIONAL LIMB WAS IMPLANTED ON THE SAME DAY TO RESOLVE THE SEPARATION ENDOLEAK. THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9641886 ↗
• InjuryMay 16, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 7.1 X 7.5 CM ABDOMINAL AORTIC ANEURYSM. THE LEFT ILIAC ARTERY WAS 22, 21, 20 MM IN DIAMETER FROM PROXIMAL TO DISTAL. THE LEFT EXTERNAL ILIAC ARTERY WAS 7 MM ¿ 6 MM IN DIAMETER AND IT WAS 28 MM IN LENGTH FROM THE LEFT INTERNAL ILIAC TO A BEND. THE RIGHT ILIAC ARTERY WAS 10 MM IN DIAMETER. IT WAS REPORTED THAT THERE WAS A RIGHT LIMB OCCLUSION WHICH REQUIRED THE PATIENT TO HAVE A FEM-FEM BYPASS PROCEDURE TO BE PERFORMED. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT RELATED TO PATIENT ANATOMY; SPECIFICALLY, SMALL AND TORTUOUS ILIAC ARTERIES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 6570515 ↗

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-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-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-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-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