Endurant® II ETLW1616C124E (UDI 00613994991591)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994991591), received between Jul 16, 2018 and Nov 26, 2024 — 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.

• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II SENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROX. 10 YEARS AND 2 MONTHS POST INDEX PROCEDURE, AN ENDURANT LIMB WAS IMPLANTED DUE TO DISEASE PROGRESSION. THE PATIENT¿S ILIAC ARTERY APPEARED TO HAVE BECOME ECTATIC OVER TIME.  PER THE PHYSICIAN THE CAUSE OF THE DISEASE PROGRESSION WAS ANATOMY RELATED DUE TO THE ECTASIA OF THE ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED, AND THE PATIENT IS FINE.

  Patient problems: Aneurysm

  MAUDE report 20783017 ↗
• InjuryOct 23, 2023Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT (ETBF2816C166E) AND ENDURANT LIMB (ETLW1616C124E) WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 6 2MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 9 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT SCAN REVEALED A TYPE IB ENDOLEAK ON THE LEFT ILIAC. TREATMENT WAS PERFORMED AND AN ADDITIONAL ENDURANT LIMB (ETLW1624C93E) WAS SUCCESSFULLY IMPLANTED RESOLVING THE ENDOLEAK.  PER THE PHYSICIAN THE CAUSE OF THE TYPE IB ENDOLEAK IS ANATOMY RELATED DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 17983920 ↗
• InjurySep 1, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 62MM ABDOMINAL AORTIC ANEURYSM IT WAS REPORTED THAT ON THE DATE OF A CT, SIX YEARS LATER. AN ENLARGING ANEURYSM SAC WAS NOTED AND WHAT APPEARED TO BE A TYPE II ENDOLEAK. A SAC PUNCTURE WAS THEN PERFORMED, UPON INJECTING CONTRAST IT WAS NOTED THERE WAS ACTUALLY A IB ENDOLEAK ON THE RIGHT ILIAC LIMB ETLW1616C124E. INTERVENTION WAS PERFORMED A MONTH LATER AND THE ENDURANT LIMB ETLW1616C124E WAS IMPLANTED AND EXTENDING JUST ABOVE THE RIGHT HYPOGA STRIC. THIS RESOLVED THE IB ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm; Injury

  MAUDE report 10475888 ↗
• MalfunctionDec 12, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF 55 MM ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2013. IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR FOLLOW UP APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE IT WAS NOTED THAT THE PATIENT POSSIBLY HAD A TYPE III ENDOLEAK ASSOCIATED WITH A GRAFT TEAR OR HOLE IN THE AREA OF THE MAIN TRUNK OF THE BIFURCATED STENT GRAFT SYSTEM. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8154341 ↗
• InjuryJul 16, 2018Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 65 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 4 YEARS AND 4 MONTHS POST INDEX PROCEDURE, A CT SHOWED THE PATIENT HAD A TYPE IB ENDOLEAK IN THE LEFT LIMB DUE TO THE GRAFT LIMB NO LONGER ENGAGING WITH THE LEFT COMMON ILIAC ARTERY. THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Injury; No Consequences Or Impact To Patient

  MAUDE report 7689438 ↗

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-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-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-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