ENDURANT® ENBF3616C145ERecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00613994762382), received between May 23, 2017 and Dec 10, 2024 — classified as 1 death, 3 injuries, 3 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT WAS TREATED FOR AN ANEURYSM USING A ENDURANT STENT GRAFT SYSTEM. APPROX. 13 YEARS, 4 MONTHS POST INDEX PROCEDURE A COMPUTED TOMOGRAPHY CONDUCTED WITHOUT CONTRAST DUE TO THE PATIENT'S POOR KIDNEY FUNCTION, REVEALED A TYPE IB ENDOLEAK. THE PHYSICIAN'S FINDINGS WERE BASED ON WHAT APPEARED TO BE NON-OPPOSED LIMBS OBSERVED IN THE IMAGING. THE HEALTHCARE PROFESSIONAL IDENTIFIED ANATOMY AND DISEASE PROGRESSION AS THE CAUSE OF THE EVENT. IT WAS CONFIRMED THAT THERE WERE NO ALLEGATIONS OR ISSUES RELATED TO THE TWO ENDURANT CUFFS IMPLANTED DURING THE INITIAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20890670 ↗
• MalfunctionAug 22, 2022Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA.  IT WAS REPORTED APPROXIMATELY 11 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CTA IDENTIFIED A TYPE IA ENDOLEAK.  PER THE PHYSICIAN THE CAUSE OF THE EVENT IS DISEASE PROGRESSION.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264195 ↗
• MalfunctionJan 17, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 53MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 9 YEARS POST THE INDEX PROCEDURE THE PATIENT RETURNED FOR A FOLLOW-UP CT WHERE A TYPE I ENDOLEAK WAS OBSERVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO DISEASE PROGRESSION.  NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13265547 ↗
• InjuryOct 11, 2017Leak/Splash; 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 RETURNED FOR FOLLOW UP. THE CT REVEALED A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT A 36 ENDURANT AORTIC CUFF AND THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED. A SNORKEL TECHNIQUE WAS ALSO PERFORMED. PER THE PHYSICIAN, THE CAUSES OF THE EVENTS WERE RELATED TO THE PATIENT ANATOMY; DILATED AORTIC NECK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6940875 ↗
• MalfunctionSep 1, 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. IT WAS REPORTED THAT THE PHYSICIAN WANTED TO DO ANOTHER FOLLOW UP EXAM AFTER A REGULAR ANNUAL ULTRASOUND. THE PATIENT WAS NOT SURE OF THE EXAM/PROCEDURE THAT NEEDED TO BE DONE BUT STATED THE PHYSICIAN MENTIONED SOMETHING ABOUT GLUING. THE PHYSICIAN CONFIRMED THAT AN ULTRASOUND REVEALED AN IRREGULARITY IN THE BLOOD FLOW BUT NO ENDOLEAK WAS OBSERVED. THE ULTRASOUND SHOWED THAT THE ANEURYSM SAC SHRANK FROM 53 MM IN DIAMETER TO 41 MM IN DIAMETER. THE CAUSE OF THE EVENT WAS UNKNOWN AND THE PHYSICIAN ELECTED TO SCHEDULE THE PATIENT FOR A FUTURE ANGIOGRAM ON AN UNKNOWN DATE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6837487 ↗
• InjuryJun 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 THE EMERGENT ENDOVASCULAR TREATMENT OF A 5.5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM AND A CONTAINED RUPTURED ILIAC ARTERY ANEURYSM. IT WAS REPORTED THAT THE PATIENT RETURNED FOR FOLLOW UP AND THERE IS A PUNCTATE FOCUS OF AIR NOTED JUST ABOVE THE AORTOILIAC BIFURCATION THAT IS NONSPECIFIC IN ETIOLOGY. NO EVIDENCE SURROUNDING THE PERIAORTIC INFLAMMATORY CHANGES. THE OPERATIVE REPORT INDICATES THAT THE ANGIOGRAM REVEALS THAT THE PREVIOUSLY REPORTED PUNCTATE FOCUS OF AIR NOTED JUST ABOVE THE AORTOILIAC BIFURCATION WAS RESOLVED. PER THE INVESTIGATOR, THE PUNCTATE FOCUS OF AIR NOTED JUST ABOVE THE AORTOILIAC BIFURCATION IS MOST LIKELY RELATED TO POSTSURGICAL IN NATURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Air Embolism

  MAUDE report 6647633 ↗
• DeathMay 23, 2017Fracture; Kinked; Leak/Splash; Migration or Expulsion of Device; Fracture; Kinked; Leak/Splash; Migration or Expulsion of Device

  ADDITIONAL INFORMATION REPORTED THAT THE PATIENT DIED ON (B)(6), 2017. THE PHYSICIAN STATED THAT THE CAUSE OF THE DEATH WAS DUE TO COMPLICATIONS FROM THE RUPTURED AORTIC ANEURYSM AND NOT PROCEDURE RELATED.

  Patient problems: Death; Rupture

  MAUDE report 6586253 ↗

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-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-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