ENDURANT® ENCF2525C49ERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994762108), received between Aug 11, 2017 and Aug 11, 2017 — classified as 1 injury.

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.

• InjuryAug 11, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT AORTIC CUFF WAS IMPLANTED PROPHYLACTICALLY IN A PATIENT DURING AN ENDOVASCULAR TREATMENT FOR A TYPE II ENDOLEAK. THE PATIENT HAD BEEN LOST TO FOLLOW UP. APPROXIMATELY FOUR YEARS AND TWO MONTHS POST INDEX PROCEDURE, A CT REVEALED THAT THE PATIENT HAD A LIKELY PROXIMAL TYPE I ENDOLEAK WITH A SEAL ZONE REGRESSION OF A COUPLE OF MILLIMETERS. THE PHYSICIAN DETERMINED THE PROXIMAL TYPE I ENDOLEAK TO BE DUE TO PROGRESSIVE PROXIMAL AORTIC NECK DILATATION. THE ANEURYSM MEASURED 13 CM IN DIAMETER. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT II AORTIC STENT GRAFT CUFF. IT WAS REPORTED THAT DURING THE SECONDARY PROCEDURE, 20FR SENTRANT SHEATH WAS ADVANCED THROUGH A PREVIOUSLY DEPLOYED BARE METAL STENT HOWEVER UNABLE TO BE ADVANCED TO INTENDED LOCATION. THE PHYSICIAN ELECTED TO REMOVE THE 20FR SENTRANT SHEATH AND MODIFIED THE CATHETER, CUTTING OFF A PORTION OF THE CATHETER. THE 20FR SENTRANT SHEATH WAS REINSERTED IN TO THE PATIENT AND THE ENDURANT AORTIC CUFF DELIVERY SYSTEM AND A FLUSH CATHETER WERE ADVANCED TO THE INTENDED LANDING ZONE. THE PHYSICIAN STATED THAT DURING DELIVERY OF THE ENDURANT AORTIC CUFF THERE WAS EXTREME DRAG, A FEW STENT RINGS WERE EXPOSED HOWEVER

  Patient problems: Injury

  MAUDE report 6787942 ↗

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