ENDURANT® ENLW1616C93ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994761958), received between Jan 16, 2018 and Jan 8, 2019 — 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 18, 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.

• InjuryJan 8, 2019Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE FOLLOW UP CT REVEALED AN ENDOLEAK WHERE THE RIGHT COMMON ILIAC HAD DILATED AND THE EXISTING LIMB PULLED OUT OF THE ILIAC AND INTO THE ANEURYSM SAC. INTERVENTION WAS COMPLETED ON (B)(6) 2018. THE PHYSICIAN EMBOLIZED THE RIGHT HYPOGASTRIC ARTERY, CANNULATED THE EXISTING LIMB AND EXTENDED THE LIMB INTO THE EXTERNAL ILIAC ARTERY. THE ENDOLEAK WAS CONFIRMED AS RESOLVED POST INTERVENTION. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY RELATED WHERE THE RIGHT COMMON ILIAC ARTERY HAD DILATED CAUSING LIMB TO LOSE SEAL AND PULL BACK INTO THE ANEURYSM. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8226351 ↗
• InjuryJan 16, 2018Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 6 YEARS POST THE INDEX PROCEDURE WITH ABDOMINAL PAIN. CT EXAM SHOWED THE LEFT LIMB OF THE IMPLANT WAS PULLED UP INTO THE ANEURYSMAL SAC AND THE RIGHT LIMB SEEMED TO BE ONLY A FEW MM INTO THE COMMON ILIAC ARTERY. IT WAS NOTED THAT THE ANEURYSMAL SAC SHOWED FLOW. THE EVENT WAS RESOLVED WITH COILING OF THE LEFT HYPO GASTRIC AND EXTENSION OF A LIMB INTO THE LEFT EXTERNAL ILIAC ARTERY AND ON THE RIGHT INTO THE HYPOGASTRIC ARTERY. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO ENLARGEMENT OF THE ILIAC ARTERIES SINCE THE INITIAL PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Abdominal Pain

  MAUDE report 7192813 ↗

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 infra
• 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 aortoili
• 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