Endurant® II ETLW1624C156E (UDI 00613994991706)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994991706), received between Jun 5, 2019 and May 1, 2026 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT A PATIENT REPRESENTATIVE CONTACTED TECHNICAL SERVICES APPROXIMATELY 14 YEARS LATER AND STATED THAT THE PATIENT EXPERIENCED AN ENDOLEAK THAT WAS REPAIRED 4 MONTHS EARLIER WITH AN ENDURANT CUFF. SUBSEQUENT INFORMATION RECEIVED CONFIRMED THAT THE ENDOLEAK WAS A TYPE IA INVOLVING THE ENDURANT BIFURCATED GRAFT. THE ENDOLEAK DID NOT RESOLVE FOLLOWING CUFF IMPLANTATION; THEREFORE, SIX ENDOANCHORS WERE PLACED, RESULTING IN A REDUCTION OF THE ENDOLEAK. THE PHYSICIAN LATER CONFIRMED THAT THE ENDOLEAK WAS FULLY RESOLVED ON FOLLOW-UP IMAGING. LACK OF WALL APPOSITION WAS NOTED IN THE LEFT LIMB; HOWEVER, NO TYPE IB ENDOLEAK WAS IDENTIFIED. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE TYPE IA ENDOLEAK WAS PROGRESSIVE DILATION OF THE AORTA SINCE THE INDEX PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25054531 ↗
• InjuryFeb 22, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 30MM ILIAC AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 8 YEARS POST THE INDEX PROCEDURE FOLLOW UP CT IDENTIFIED A TYPE IB ENDOLEAK WITH ANEURYSM GROWTH IN THE INTERNAL ILIAC. INTERVENTION WAS COMPLETED WITH COILING OF THE HYPOGASTRIC ARTERY AND THE LIMB WAS EXTENDED INTO THE INTERNAL ARTERY AND THE ENDOLEAK WAS RESOLVED. PER PHYSICIAN THE CAUSE OF THE TYPE IB ENDOLEAK WAS ANATOMY RELATED WHERE THE ANEURYSM GREW. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 13577039 ↗
• MalfunctionJun 5, 2019Migration or Expulsion of Device; 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 OF UNKNOWN SIZE. IT WAS REPORTED THAT CT 3 YEARS LATER SHOWED THAT THE LEFT LIMB HAD MIGRATED BACK. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8670319 ↗

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-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-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-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