ENDURANT® ENTF3636C70ERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994762023), received between Aug 25, 2017 and Aug 25, 2017 — classified as 1 death.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathAug 25, 2017Leak/Splash; Leak/Splash

  A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT DURING AN ENDOVASCULAR TREATMENT OF A 10.5CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CHEST PAIN. A TYPE IA ENDOLEAK WAS DISCOVERED JUST BELOW THE RENAL ARTERIES. THE PHYSICIAN DECIDED TO IMPLANT HELI-FX ENDOANCHORS. 6 ANCHORS WERE PLACED ON THE RIGHT AND 3 ON THE LEFT. THIS DIMINISHED THE LEAK BUT DID NOT ELIMINATE IT COMPLETELY. THE PHYSICIAN DETERMINED THAT THERE WAS A TYPE IV ENDOLEAK IN THE PREVIOUSLY IMPLANTED TALENT STENT GRAFT. THE PHYSICIAN PERFORMED AN OPEN SURGERY ON THE PATIENT AND DETERMINED THAT THE ENDURANT STENT GRAFT HAD A PROXIMAL TYPE I ENDOLEAK AND THE TALENT STENT GRAFT HAD A TYPE IV FABRIC ENDOLEAK. THE PHYSICIAN NOTED THAT, PRIOR TO THE EXPLANT, THERE WERE AT LEAST EIGHT TINY HOLES IN THE TALENT GRAFT MATERIAL THAT CONTRIBUTED TO ANEURYSM SAC GROWTH. THE PHYSICIAN PLACED A HEMASHIELD GRAFT BUT THE PATIENT EXPIRED DURING THE OPEN PROCEDURE. PER THE PHYSICIAN, THE CAUSE OF DEATH WAS DUE TO EXCESSIVE BLOOD LOSS AND THE PATIENT WAS NOT CLOSED DUE TO TH

  Patient problems: Blood Loss; Death; Pain

  MAUDE report 6819832 ↗

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