ENDURANT® ENBF3220C166ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994762399), received between Aug 12, 2021 and Dec 6, 2023 — classified as 1 injury, 1 malfunction.

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.

• MalfunctionDec 6, 2023Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 55 X 57MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 12 YEARS POST THE PROCEDURE, FOLLOW UP CT SCAN REVEALED A POSSIBLE TYPE III ENDOLEAK LOCATED IN THE DISTAL AORTA, HOWEVER IT IS UNCLEAR WHICH ILIAC LIMB CONTAINED THE AFFECTED. IT WAS NOTED THE PATIENT IS ASYMPTOMATIC. PER THE PHYSICIAN THE CAUSE OF THE SUSPECTED TYPE III ENDOLEAK IS DUE TO A HOLE WORN IN THE GRAFT. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18272701 ↗
• InjuryAug 12, 2021Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATE STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A CT WAS PERFORMED WHERE A SUSPECTED TYPE 1A ENDOLEAK WAS OBSERVED. AN AORTOGRAM WAS CARRIED OUT AND CONFIRMED TYPE 1A ENDOLEAK AS SUSPECTED ON CT. INTERVENTION WAS PERFORMED WHERE THE PHYSICIAN SNORKELED THE LEFT RENAL AND PLACED A 36 MM ENDURANT AORTIC CUFF AT THE LEVEL OF THE HIGHER RIGHT RENAL ARTERY AND BALLOONING WAS THEN PERFORMED. A FINAL ANGIOGRAM WAS PERFORMED AND SHOWED NO ENDOLEAK REMAINING. AS PER PHYSICIAN, THE CAUSE OF THE EVENT IS DUE TO NECK DILATION OVER 10 YEARS SINCE IMPLANT. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12312388 ↗

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