ENDURANT® ENBF3620C145ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994762368), received between Mar 1, 2018 and Nov 22, 2018 — 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.

• InjuryNov 22, 2018Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 69MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A CT SCAN CARRIED OUT APPROXIMATELY SIX YEARS LATER REVEALED AN UNKNOWN ENDOLEAK. AN ENDURANT CUFF AND TWO ENDURANT LIMBS WERE INSERTED BUT THE ENDOLEAK WAS VISIBLE ABOVE THE GRAFT BUT NOT VISIBLE WHEN INSIDE THE GRAFT. THE PHYSICIAN ELECTED TO IMPLANT ENDOANCHORS AND A NON MDT STENT GRAFT HOWEVER THE ENDOLEAK HAS NOT RESOLVED AND THE PHYSICIAN ENDED THE PROCEDURE AT THIS TIME. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS POSSIBLY DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury

  MAUDE report 8098470 ↗
• InjuryMar 1, 2018Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR AN ABDOMINAL AORTIC ANEURYSM. AN ANGIOGRAM SHOWED THERE TO BE A TYPE III SEPARATION BETWEEN THE BIFURCATION STENT GRAFT AND THE LEFT ILIAC LIMB STENT GRAFT EXTENSION. INTERVENTION WAS CARRIED OUT ON THE SAME DATE TO RESOLVE THE ENDOLEAK, AN ETLW1620C156E WAS PLACED EVEN TO THE FLOW DIVIDER WITHIN THE BIFURCATION AND EXTENDING AS FAR AS THE DISTAL END OF THE PREVIOUSLY IMPLANTED LIMB EXTENSION. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO THE PATIENT¿S ANATOMY, ANGULATION OF THE PREVIOUS OVERLAP OCCURRED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7306407 ↗

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-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-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-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