ENDURANT® ENLW1616C124ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994761941), received between Jan 30, 2017 and Nov 6, 2024 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2024Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED A FOLLOW UP CT SCAN CONDUCTED APPTOX. 13 YEARS, 6 MONTHS POST INDEX PROCEDURE, REVEALED A SUSPECTED ENDOLEAK BUT IT WAS NOT CONFIRMED. THE PHYSICIAN SCHEDULED AN EXPLORATORY ANGIOGRAM 18 DAYS LATER WHICH IDENTIFIED A SUSPECTED TYPE IB ENDOLEAK ON THE LEFT ILIAC ENDURANT LIMB. INTERVENTION WAS PERFORMED ON THE SAME DAY AND A ENDURANT (ETLW1620C93E) LIMB EXTENSION WAS IMPLANTED TO ADDRESS THE ENDOLEAK FIX THE LEAK, EFFECTIVELY RESOLVING IT. PER THE PHYSICIAN THE CAUSE OF THE TYPE IB ENDOLEAK WAS ANATOMY RELATED DUE THE LEFT ILIAC ENLARGING OVER TIME EXCEEDING THE ORIGINAL STENT DIAMETER SINCE THE INITIAL IMPLANTATION. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 20619647 ↗
• InjuryNov 9, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II WAS INTENDED TO BE IMPLANTED DURING A SECONDARY ENDOVASCULAR PROCEDURE TO EXTENDED ANOTHER STENT GRAFT. IT WAS CONFIRMED THAT THE DEVICE BEING EXTENDED WAS A MEDTRONIC DEVICE (MODEL ENLW1616C124E, SN (B)(4)) IT WAS EXTENDED DUE TO COMMON ILIAC ENLARGEMENT AND TYPE 1B ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12778179 ↗
• InjuryAug 16, 2021Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 52 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A ROUTINE CT PERFORMED UNDER 10 YEARS LATER SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK AND A IB ENDOLEAK ON THE ENDURANT LIMB (V00885373). INTERVENTION WAS PERFORMED ABOUT A MONTH LATER. AN ENDURANT CUFF AND ENDOANCHORS WERE IMPLANTED, WHICH RESOLVED THE IA ENDOLEAK. FOLLOWING THIS, AN ATTEMPT WAS MADE TO REPAIR THE IB ENDOLEAK. THE PHYSICIAN DID NOT HAVE CONSENT TO COIL AND COVER THE LEFT HYPOGASTRIC ARTERY SO THE PHYSICIAN EXTENDED WITH AN ETLW1620C93E ENDURANT LIMB BUT THIS PROVED UNSUCCESSFUL AND THE IB ENDOLEAK REMAINED. AS PER THE PHYSICIAN THE CAUSE OF THE IA ENDOLEAK COULD NOT BE DETERMINED. THE CAUSE OF THE IB ENDOLEAK WAS STATED TO BE AS A RESULT OF CONTINUED ANEURYSMAL DISEASE OF THE ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 12323810 ↗
• InjuryJan 30, 2017Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT WAS LOST TO FOLLOW UP. THE PATIENT PRESENTED WITH ABDOMINAL PAIN. THE CT REVEALED THAT THERE ANEURYSM EXPANSION, CURRENTLY 7.6 CM IN DIAMETER, THE PROXIMAL EDGE OF THE BIFURCATED STENT GRAFT WAS 6 MM BELOW THE RENAL ARTERY HOWEVER THERE WAS A GOOD SEAL WITH NO ENDOLEAKS PROXIMALLY, AND BILATERAL DISTAL TYPE I ENDOLEAKS. THERE WAS DILATATION OF RIGHT ILIAC ARTERY AND A SHORT COMMON ILIAC ARTERY CAUSING LOSS OF SEAL RESULTING IN THE ENDURANT IPSILATERAL ILIAC LIMB PULLING BACK INTO ANEURYSM SAC. THE PHYSICIAN ELECTED TO IMPLANT TWO ENDURANT ILIAC STENT GRAFTS BILATERALLY AND THE BILATERAL DISTAL TYPE I ENDOLEAKS WERE RESOLVED. THE PHYSICIAN STATED THE CAUSES OF THE EVENTS WERE RELATED TO THE PATIENT¿S ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 6288174 ↗

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-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-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