Endurant® II ETBF2813C124ERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994991287), received between Mar 30, 2017 and Mar 30, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Occlusion Within Device” (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.

• InjuryMar 30, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ULCER. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH RIGHT LEG PAIN. THE PATIENT WAS DIAGNOSED WITH OCCLUSION OF THE ENDURANT STENT GRAFT. THE PHYSICIAN IMPLANTED A BALLOON EXPANDABLE STENT FROM THE RIGHT IPSILATERAL LIMB TO THE RIGHT COMMON ILIAC ARTERY AT THE LEVEL OF THE AORTIC BIFURCATION. THE EVENT WAS RESOLVED. THE PATIENT RE-PRESENTED WITH RIGHT LEG PAIN. THERE WAS STENT GRAFT OCCLUSION. THE PHYSICIAN PERFORMED A FEMORAL-FEMORAL GRAFT BYPASS AND THE BLOOD FLOW WAS RESTORED. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS RELATED TO THE PATIENT¿S ANATOMY, TIGHT STENOSIS PRE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion; Pain

  MAUDE report 6447646 ↗

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-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-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