ENDURANT® ENEW2020C82ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994762146), received between Jul 19, 2017 and Aug 17, 2021 — classified as 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2021Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT A CT WAS PERFORMED 10 YEARS LATER WHERE A ENDOLEAK TYPE 3A WAS OBSERVED. ADDITIONALLY, A DISTAL LEFT COMMON ILIAC ANEURYSM HAD DEVELOPED IN THE INTERIM. IT WAS STATED THAT A INADEQUATE OVERLAP OF 10-13MM BETWEEN THE ENLW1620C93E RIGHT LIMB AND ENEW2020C82E RIGHT DISTAL EXTENSION WAS NOTED DURING THE INITIAL FOLLOW-UP PERFORMED ONE MONTH POST INDEX PROCEDURE. AN INITIAL ANGIOGRAM CONFIRMED A COMPLETE DIS-ASSOCIATION OF THE RIGHT LIMB AND DISTAL EXTENSION, INTERVENTION WAS PERFORMED APPROXIMATELY 6 WEEKS POST CT WHERE AN ETEW2020C82E ILIAC EXTENSION WAS ADDITIONALLY IMPLANTED TO SPAN THE GAP AND SUCCESSFULLY RESOLVE THE TYPE 3A LEAK A NON-MEDTRONIC DEVICE WAS THEN DEPLOYED INTO THE LEFT INTERNAL ILIAC ARTERY, AFTER WHICH A ETLW1610C199E LIMB WAS DELIVERED INTO THE ETLW1624C93E LEFT ILIAC DEVICE TO EXTEND THE SEAL BEYOND THE ILIAC ANEURYSM AND ACHIEVE SEAL IN THE PROXIMAL LEFT EXTERNAL ILIAC ARTERY. AN ANGIOGRAM CONFIRMED ADEQUATE DISTAL SEAL AND SUCCESSFUL OCCLUSION OF THE LEFT HYPO, IT WAS DECIDED THE PROXIMAL OVERLAP OF THE ETLW1610C199E NEEDED TO BE EXTENDED WITH A ETLW1616C124E

  Patient problems: Insufficient Information

  MAUDE report 12330007 ↗
• InjuryApr 16, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN APPROXIMATELY SEVEN YEARS LATER AND CT SHOWED A TYPE IB ENDOLEAK ON THE RIGHT. IT WAS NOTED THAT THE RIGHT COMMON ILIAC ARTERY HAD DILATED AND NOW MEASURED 30MM. THE ORIGINAL IMPLANT ON THIS SIDE HAD A 20MM DIAMETER. THE PHYSICIAN COILED THE RIGHT HYPOGASTRIC AND THEN IMPLANTED THREE LIMBS ON THE RIGHT SIDE. IT WAS NOTED THAT THE LEFT SIDE ILIAC DIAMETER HAD ENLARGED AND WAS NOW 20MM WITH A 13MM DIAMETER STENT GRAFT PREVIOUSLY IMPLANTED, SO ANOTHER EXTENSION WAS ALSO IMPLANTED HERE. THE FINAL ANGIOGRAM SHOWED RESOLUTION OF THE TYPE IB ENDOLEAK AND GOOD PERFUSION TO THE LEFT HYPOGASTRIC ARTERY. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO NATURAL HISTORY OF ANEURYSM DISEASE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Abdominal Pain

  MAUDE report 8517505 ↗
• MalfunctionJun 15, 2018Leak/Splash; Occlusion Within Device; Leak/Splash; Occlusion Within Device

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF AN UNKNOWN SIZE. IT WAS REPORTED THAT A CT EXAM PERFORMED APPROXIMATELY 7 YEARS POST INDEX PROCEDURE, SHOWED THAT THERE WAS THROMBUS OF THE RIGHT LIMB (B)(4) AND A TYPE III SEPARATION IN THE LEFT LIMB BETWEEN THE BIFURCATE AND LEFT LIMB EXTENSION. THESE LIMBS WERE NOTED ON CT TO BE COMPLETELY OCCLUDED. THE CT ALSO SHOWED ANEURYSM EXPANSION. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS CURRENTLY UNKNOWN. IT WAS REPORTED THE EVENT IS NOT RESOLVED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7605732 ↗
• InjuryJul 19, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A GREATER THAN 5CM DIMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING A RECENT FOLLOW UP THE CT DEMONSTRATED A DISTAL TYPE I ENDOLEAK WITH ANEURYSM SAC EXPANSION. THE PHYSICIAN IMPLANTED ANOTHER ILIAC LIMB DISTALLY AND THE DISTAL TYPE I ENDOLEAK WAS RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE DISTAL TYPE I ENDOLEAK WAS PATIENT ANATOMY RELATED, AORTIC REMODELING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6726997 ↗

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