ENDURANT® ENBF2516C166ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994762221), received between Mar 20, 2017 and May 4, 2018 — classified as 5 injuries.

The most frequently reported specific device problem is “Leak/Splash” (2 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.

• InjuryMay 4, 2018Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT NECK DILATION AND A TYPE IA ENDOLEAK WERE OBSERVED ON A CT SCAN COMPLETED APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE. THE PHYSICIAN ATTRIBUTED THE CAUSE OF THE EVENT TO NECK DILATION. IT WAS REPORTED THAT THE ENDURANT STENT GRAFT WAS PLACED LOW IN THE AORTIC NECK DURING THE INDEX PROCEDURE, NO MIGRATION OCCURRED AND THE TYPE IA ENDOLEAK WAS CAUSED BY NECK DILATION. THE PATIENT RECEIVED TREATMENT WITH AN ENDURANT AORTIC EXTENSION AND SIX ENDOANCHORS. THE EVENT WAS RESOLVED AND NO LEAK WAS IDENTIFIED ON THE FINAL ANGIOGRAM. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7487310 ↗
• InjurySep 11, 2017Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 8.0 CM ABDOMINAL AORTIC ANEURYSM. IT WAS NOTED THAT THERE WAS 30 DEGREES OF ANGULATION. IT WAS REPORTED THAT THE PATIENT PREVIOUSLY HAD ANOTHER MANUFACTURER¿S CUFF AND LIMB IMPLANTED FOR A TYPE IA AND IB, RESPECTIVELY. THE TYPE IB REPORTEDLY RESOLVED BUT THE TYPE IA REMAINED. THE PATIENT THEN PRESENTED EMERGENTLY WITH A MIGRATION AND TYPE IA ENDOLEAK. 18 HELI-FX ENDOANCHORS WERE IMPLANTED ALONG WITH A 32 ENDURANT AORTIC CUFF AND ANOTHER MANUFACTURER¿S STENT. A LEAK STILL REMAINED BUT IT COULD NOT BE DETERMINED IF IT WAS A TYPE IA OR A TYPE II. THE PHYSICIAN STATED THAT THE CAUSE OF THE MIGRATION AND TYPE IA WAS DUE TO DISEASE PROGRESSION; AND THE CAUSE OF THE TYPE IB WAS DUE TO UNDER-SIZING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED BY THEIR PHYSICIAN.

  Patient problems: Injury

  MAUDE report 6855458 ↗
• InjurySep 4, 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 THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH ADDITIONAL LIMBS (23X13X145 AND 16X13X93) IMPLANTED. THE PATIENT¿S AAA HAS GROWN FROM LESS THAN 3CM TO 5CM. A SECONDARY INTERVENTION WAS PERFORMED AND AN ENDURANT II CUFF, WITH HELI-FX ENDOANCHORS, WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD CHEST PAIN AND WAS ADMITTED FOR WHAT WAS THOUGHT TO BE A MYOCARDIAL INFARCTION. A CT SCAN WAS DONE OF THE ABDOMEN AND IT WAS DETERMINED THAT THE PATIENT HAD AN IVC FILTER THAT HAS STUCK THE IPSILATERAL LIMB OF THE STENT GRAFT ON THE RIGHT SIDE. IN ADDITION, THERE ALSO APPEARS TO BE A DISTAL TYPE I ENDOLEAK. THE PHYSICIAN, THE CAUSE OF THE TYPE IB ENDOLEAK WAS DUE TO ANATOMY CHANGES AND POSSIBLY FROM THE IVC FILTER STICKING IN THE IPSILATERAL LIMB OF THE STENT GRAFT ON THE RIGHT SIDE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED BY THEIR PHYSICIAN.

  Patient problems: Myocardial Infarction; Pain

  MAUDE report 6840974 ↗
• InjuryAug 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY SEVEN YEARS AFTER THE INDEX PROCEDURE , THE PATIENT PRESENTED EMERGENTLY. THE PATIENT ACQUIRED INFECTION FROM URETHRAL CATHERIZATION. AS A RESULT, THE STENT GRAFT WAS INFECTED. THE PATIENT RECEIVED TREATMENT. THE STENT GRAFT SYSTEM WAS EXPLANTED AND AN OPEN TUBE GRAFT WAS IMPLANTED. THE EVENT WAS RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENTS COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Unspecified Infection

  MAUDE report 6799800 ↗
• InjuryMar 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CORRECTION: A 28X14X102 DEVICE WAS IMPLANTED IN THE EXISTING STENT GRAFT ON THE RIGHT IPSILATERAL SIDE. IT WAS NOTED THAT IT WAS LANDED 1CM PROXIMAL TO THE PREVIOUS STENT GRAFT, WHICH WAS ~ 8MM BELOW THE LOWEST LEFT RENAL ARTERY. THE EVENT WAS REPORTEDLY RESOLVED AND THE PROCEDURE WAS COMPLETED. THE NEXT DAY, THE PATIENT'S CREATININE HAD INCREASED FROM 2.3 PRE-PROCEDURE TO 3. THE PATIENT WAS NOT MAKING ANY URINE.

  Patient problems: Pain; Rupture

  MAUDE report 6419390 ↗

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-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-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