ENDURANT® ENLW1610C124ERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994762009), received between Dec 18, 2020 and Dec 18, 2020 — 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.

• DeathDec 18, 2020Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 5 MONTHS POST IMPLANT THE PATIENT HAD A IB ENDOLEAK OF THE LEFT LIMB. INTERVENTION WAS PERFORMED AND THE PHYSICIAN PLACED COILS BEHIND THE LIMB OF THE GRAFT AND THE ENDOLEAK APPEARED TO BE RESOLVED. APPROXIMATELY 5 MONTHS LATER, THE PATIENT PRESENTED WITH A RUPTURED ANEURYSM. THE PATIENT WAS REPORTED AS VERY UNSTABLE. THERE APPEARED TO BE IA ENDOLEAK OBSERVED ON ANGIO AND AN ENDURANT AORTIC CUFF WAS IMPLANTED. AN ENDURANT LIMB WAS BEING PREPPED TO BE IMPLANTED NEXT BUT AS THIS WAS BEING DONE, THE PATIENT BECAME PULSELESS. CPR WAS PERFORMED BUT THE PATIENT DID NOT RESPOND AND THE PATIENT EXPIRED. AS PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAKS ARE UNKNOWN. THE CAUSE OF THE RUPTURE WAS REPORTEDLY DUE TO THE IB ENDOLEAK. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: Rupture

  MAUDE report 11035888 ↗

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-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-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-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