ENDURANT® ENBF3216C124ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994762443), received between Jun 1, 2017 and Jul 26, 2017 — 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.

• InjuryJul 26, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 8CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH ABDOMINAL PAIN. A CT SCAN REVEALED A POSSIBLE TYPE IA LEAK. AN INTERVENTION WAS PERFORMED USING HELI-FX ENDOANCHORS. THE HELI-FX GUIDE WAS DEFLECTED BETWEEN 0 AND 45 DEGREES ON DIFFERENT ENDOANCHOR DEPLOYMENT ATTEMPTS. IT WAS REPORTED THAT AFTER DEPLOYMENT OF THE THIRD ENDOANCHOR, THE APPLIER HAD DIFFICULTY PASSING THROUGH THE GUIDE. A NEW GUIDE WAS SELECTED AND A TOTAL OF ELEVEN ENDOANCHORS WERE IMPLANTED RESOLVING THE TYPE IA ENDOLEAK. PER THE PHYSICIAN, THE CAUSE OF THE ENDOLEAK WAS DUE TO THE PATIENT¿S ANATOMY; PROXIMAL AORTIC NECK DILATATION. PER THE PHYSICIAN, THE CAUSE OF THE INSERTION DIFFICULTY WAS DUE TO A KINK IN THE TIP OF THE HEL-FX GUIDE THAT OCCURRED DURING THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury; Pain

  MAUDE report 6744549 ↗
• InjuryJun 1, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT RETURNED FOR FOLLOW UP, AND A PROXIMAL TYPE I ENDOLEAK WAS IDENTIFIED. TWO DAYS LATER THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT AORTIC CUFF AND HELI-FX APTUS ENDOANCHORS AND THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE PROXIMAL TYPE I ENDOLEAK IS RELATED TO DISEASE PROGRESSION IN THE AORTIC NECK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6604998 ↗

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-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-0290-2022 · Oct 15, 2021 · Open, Classified
  Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
• 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