ENDURANT® ENBF2516C145ERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994762238), received between Jun 16, 2017 and Feb 6, 2024 — classified as 1 death, 5 injuries.

The most frequently reported specific device problem is “Leak/Splash” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

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

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 106MM AAA. IT WAS REPORTED THAT A CT WAS TAKEN APPROXIMATELY 13 YEARS POST THE INDEX PROCEDURE SHOWED A TYPE IA ENDOLEAK. IT WAS NOTED THAT THE PATIENT HAD A NON-MDT CUFF AND LIMBS PRESENT WITHIN THE ENDURANT GRAFT WHICH WERE IMPLANTED ON AN UNKNOWN DATE. THE ENDURANT STENT GRAFTS AND NON-MDT STENT GRAFTS WERE EXPLANTED. THE PATIENTS CONDITION IS POST THE EXPLANT PROCEDURE WAS NOTED AS ALIVE AND WELL. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK WAS ANATOMY RELATED AND DUE TO AORTIC NECK DEGENERATION. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 18650650 ↗
• InjuryAug 10, 2022Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A  AAA.  IT WAS REPORTED WHEN THE PATIENT RETURNED FOR FOLLOW-UP , A TYPE IA ENDOLEAK WAS NOTED ON CTA.  PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY AND AORTIC NECK DILATION OVER TIME.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15202311 ↗
• InjurySep 14, 2021Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN APPROX. 60MM MM ABDOMINAL AORTIC ANEURYSM. ENDOLEAK TYPE 1A WAS OBSERVED ON A FOLLOW-UP VISIT ON AN UNKNOWN DATE (APPROX. 10 YEARS LATER). A CUFF WAS PLACED TO RESOLVE THE ISSUE. IT WAS REPORTED DURING THE INTERVENTION THE DEVICE CAUGHT ON THE SUPRA RENAL STENTS MAKING THE STENT GRAFT PUSH UP WHILE THE PHYSICIAN WAS TRYING TO RETRIEVE THE DEVICE. IT WAS REPORTED THE DELIVERY SYSTEM WAS VERY DIFFICULT TO RETRIEVE OR ADVANCE AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12465879 ↗
• InjuryJul 25, 2018Leak/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 5 YEARS POST INDEX PROCEDURE, THE PATIENT PRESENTED AT FOLLOW UP WITH A TYPE IA ENDOLEAK. INTERVENTION WAS COMPLETED WITH THE PLACEMENT OF ENDOANCHORS AND BALLOON ANGIOPLASTY AND THE ENDOLEAK RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO THE EXCESS CALCIFICATION PRESENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Calcium Deposits/Calcification; Hemorrhage/Blood Loss/Bleeding; Injury

  MAUDE report 7717635 ↗
• InjurySep 1, 2017Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 23MM IN DIAMETER AND 15MM IN LENGTH WITH 10 DEGREE ANGULATION. IT WAS REPORTED THAT A CT ON AN UNKNOWN DATE SHOWED THERE WAS AN ENDOLEAK. IT WAS ALSO NOTED THAT THE STENT GRAFT WAS LANDED LOW AT THE TIME OF THE ORIGINAL IMPLANT AND WITH THE DISEASE PROGRESSING PROXIMALLY IT CREATED AN ENDOLEAK. THE PHYSICIAN PLACED A 25MM DIAMETER AORTIC CUFF AND 6 ENDOANCHORS AND THE ENDOLEAK WAS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO THE STENT GRAFT BEING PLACED LOW ORIGINALLY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6837311 ↗
• DeathJun 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT EXPIRED ON AN UNKNOWN DATE OF AN UNKNOWN CAUSE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death

  MAUDE report 6647748 ↗

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-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-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 aort
• 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 i
• 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