Endurant® II ETLW1624C124E (UDI 00613994991690)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994991690), received between May 18, 2018 and Sep 21, 2020 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNMOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING A FOLLOW-UP, APPROXIMATELY 78 MONTHS POST INDEX PROCEDURE, IT WAS NOTED THAT THE ETLW1624C124E ENDURANT LIMB ON LEFT SIDE OF THE PATIENT WAS NO LONGER SEALED IN LEFT COMMON ILIAC ARTERY. IT WAS STATED THE LIMB WAS RELINED WITH AN ENDURANT II STENT GRAFT AND A NON-MEDTRONIC DEVICE WAS DEPLOYED TO TREAT THE EVENT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 10559197 ↗
• InjuryDec 2, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 90 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW UP APPROXIMATELY 5 YEARS POST INDEX PROCEDURE WITH ABDOMINAL PAIN. AN ENLARGED AAA SAC WAS OBSERVED ON THE CTA, WHICH THE PHYSICIAN BELIEVED TO BE DUE TO A TYPE IIIA SEPARATION LEAK BETWEEN THE BOTTOM OF THE MAIN BODY LIMB AND THE ENDURANT II LIMB EXTENSION. THE PATIENT WAS TREATED WITH IMPLANT OF AN ADDITIONAL LIMB TO BRIDGE THE TYPE IIIA ENDOLEAK. THE EVENT WAS THEN RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS RELATED TO THE PATIENT'S ANATOMY. IT WAS NOTED THAT THERE WAS LARGE AAA SAC WITH NO THROMBUS, AND THAT THE PHYSICIAN BELIEVED THAT THE PATIENT'S DISEASE WAS PROGRESSING IN THE NECK AND ILIAC'S OF THE AORTA. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Abdominal Pain

  MAUDE report 9395338 ↗
• InjuryMay 28, 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 ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 6 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT DEMONSTRATED THE PATIENT'S RIGHT ILIAC HAS EXPANDED AND NOW MEASURES 30MM. THE RIGHT ILIAC LIMB OF THE GRAFT WAS NOW POSITIONED AT THE AORTIC BIFURCATION, CAUSING A TYPE IB ENDOLEAK. INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT 2 ENDURANT LIMBS TO CREATE A DISTAL SEAL EXTENDING FROM THE GRAFT FLOW DIVIDER TO THE RIGHT EXTERNAL ILIAC. THE GRAFTS WERE BALLOONED AND FINAL ANGIO CONFIRMED THE ENDOLEAK HAS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY RELATED DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8645193 ↗
• MalfunctionDec 4, 2018Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT IDENTIFIED A DISTAL TYPE IB ENDOLEAK WITH LOSS OF SEAL. THE LIMB HAS RETRACTED OUT OF THE RCIA AND BACK INTO ANEURYSM. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY RELATED DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8128416 ↗
• InjuryMay 18, 2018Occlusion Within Device; Occlusion Within Device

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 72 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED TO A HOSPITAL WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, AN ANGIOGRAM WAS PERFORMED, AND A TYPE IIIB ENDOLEAK WAS OBSERVED DUE TO A TEAR IN THE BIFURCATE. AN AUI WAS USED TO REALIGN THE EXISTING STENT GRAFT AND NO LEAK WAS VISIBLE DURING THE FINAL RUN. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. ADDITIONAL INFORMATION RECEIVED AND IT WAS REPORTED THAT AFTER THE INDEX PROCEDURE IN 2014 THERE WAS AN OCCLUSION OF THE RIGHT LIMB. THE PATIENT UNDERWENT A FEM-FEM BYPASS TO IMPROVE THE CIRCULATION BUT THE OCCLUSION RETURNED ALONG WITH INFECTION WHICH THEN REQUIRED THE REMOVAL OF THE FEM-FEM BYPASS TO CONVERT TO A RIGHT AUXILIARY TO POPLITEAL BYPASS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury; Ischemia; Occlusion; Unspecified Infection

  MAUDE report 7525429 ↗

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-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-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