Endurant® II ETLW1624C82E (UDI 00613994991676)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994991676), received between Jul 10, 2017 and Feb 5, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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.

• MalfunctionFeb 5, 2025Leak/Splash; Leak/Splash

  TWO ENDURANT II STENT GRAFT WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN AAA. IT WAS REPORTED THAT A CT TAKEN REVEALED POSSIBLE BILATERAL IB ENDOLEAKS. IT WAS SAID THERE IS A SUSPECTED IB ENDOLEAK COMING FROM THE LCIA AND DISEASE PROGRESSION FROM THE RCIA WHICH IS NOW ANEURYSMAL. NO CAUSE WAS PROVIDED. NO OTHER CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm

  MAUDE report 21312250 ↗
• InjuryMar 6, 2018Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZED DISSECTION. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO EMERGENCY ROOM (ER) WITH A RUPTURE APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE CONFIRMED ON CT. THE PATIENT HAD DEVELOPED A TYPE IB ENDOLEAK FROM THE RIGHT COMMON ILIAC ARTERY, THE PATIENTS VITALS WERE REPORTEDLY STABLE. THE PATIENT RECEIVED TREATMENT WITH TWO EXTENSION LIMBS PLACED IN THE RIGHT COMMON ILIAC ARTERY AND THE ENDOLEAK RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED BUT IT IS LIKELY DUE TO THE TYPE IB THAT WAS OBSERVED DURING THE INTERVENTION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 7317629 ↗
• MalfunctionJul 10, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A RECENT ULTRASOUND REVEALED A POSSIBLE DISTAL TYPE I ENDOLEAK. CURRENTLY THE ANEURYSM IS 5.5 CM IN DIAMETER. PER THE PHYSICIAN, THE CAUSES OF THE EVENTS ARE UNKNOWN. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THE PHYSICIAN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6698945 ↗

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