Endurant® II ETLW1610C124E (UDI 00613994991096)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994991096), received between Apr 4, 2018 and Oct 13, 2021 — 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.

• InjuryOct 13, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED ON AN UNKNOWN DATE APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE, A TYPE IB ENDOLEAK WAS OBSERVED THROUGH LIMB ETLW1610C124E. INTERVENTION WAS PERFORMED ON THE (B)(6) OF (B)(6) 2021, WHERE ANOTHER ENDURANT LIMB WAS IMPLANTED TO EXTEND THE RIGHT LIMB. THERE WAS NO LEAK SEEN ON FINAL ANGIOGRAM.  AS PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12623758 ↗
• InjuryApr 4, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT, APPROXIMATELY 4 YEARS POST INDEX PROCEDURE THE PATIENT PRESENTED WITH ABDOMINAL TENDERNESS. ON CT EXAM THERE APPEARED TO BE A TYPE IA ENDOLEAK. THE NEXT DAY, AFTER ENDOANCHORS DEPLOYMENT FOR THE TYPE IA ENDOLEAK, THE ANGIOGRAM REVEALED A JETTING ENDOLEAK FROM THE WALL OF THE MAIN BODY OF THE BIFURCATED DEVICE. AN AORTIC CUFF WAS DEPLOYED AND SEALED THE HOLE BUT ON THE NEXT ANGIOGRAM ANOTHER HOLE WAS OBSERVED IN THE CONTRALATERAL LIMB. THE PHYSICIAN RELINED THE LIMB WITH A 16X16X82 ENDURANT LIMB AND THE FINAL ANGIOGRAM SHOWED THE ENDOLEAK HAD RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury; Pain

  MAUDE report 7395029 ↗

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-0290-2022 · Oct 15, 2021 · Open, Classified
  Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
• 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