ENDURANT® ENCF3232C49ERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994762085), received between Mar 20, 2018 and Dec 4, 2020 — classified as 1 death, 2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2020Fracture; Leak/Splash; Adverse Event Without Identified Device or Use Problem; Fracture; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ANEURX BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. AN ENDURANT CUFF WAS THEN IMPLANTED APPROXIMATELY 9 YEARS AND 5 MONTHS LATER AND APPROXIMATELY 2 YEARS AND 11 MONTHS LATER 2 ENDURANT AORTIC EXTENSIONS WERE IMPLANTED. IT WAS REPORTED THROUGH TECHNICAL SERVICES APPROXIMATELY 18 YEARS POST INDEX PROCEDURE, THAT ONE OF THE STENT GRAFTS HAS A FRACTURED STENT. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 10947981 ↗
• InjuryMar 20, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II EXTENSION CUFF AND AN ANUERX STENT GRAFT SYSTEM WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF UNKNOWN SIZE. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY, APPROXIMATELY 8 YEARS POST IMPLANT, WITH A RUPTURED ANEURYSM, DUE TO A TYPE IA ENDOLEAK. IT WAS REPORTED THAT THE ENDURANT CUFF HAD LOST PROXIMAL SEAL, LEADING TO THE TYPE IA ENDOLEAK. THE PHYSICIANS IMPLANTED AN ADDITIONAL ENDURANT II CUFF AND 12 HELI-FX ENDOANCHORS AS TREATMENT, INTENTIONALLY COVERING THE PATIENT'S RENAL ARTERIES IN ORDER TO GAIN A MORE ROBUST PROXIMAL SEAL. A RELIANT BALLOON WAS USED TO IRON THE CUFF. AN ANGIOGRAM WAS THEN PERFORMED, WHICH SHOWED CONTINUAL FILLING WITHIN THE ANEURYSM FROM THE TYPE IA ENDOLEAK. THE PHYSICIANS THEN RE-BALLOONED USING THE RELIANT AND IMPLANTED A FURTHER 4 ENDOANCHORS WITHIN THE STENT GRAFT MATERIAL. ANOTHER ANGIOGRAM WAS THEN PERFORMED, SHOWING THAT THERE WAS STILL SOME FILLING WITHIN THE ANEURYSM. THE PHYSICIANS ELECTED TO END THE PROCEDURE AND OBTAIN A FOLLOW-UP CT ON A LATER DATE. THE PHYSICIAN STATED THE CAUSE OF THE EVENT WAS ANATOMY RELATED, DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WER

  Patient problems: Rupture

  MAUDE report 8435513 ↗
• DeathMar 20, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED UNKNOWN DIAMETER ABDOMINAL AORTIC ANEURYSM AND SUBSEQUENT IMPLANTATION OF ANOTHER ANEURX STENT GRAFT AND ENDURANT STENT GRAFT WAS ALSO PERFORMED. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS RECEIVING TREATMENT WITH THE ATTEMPTED IMPLANTATION OF AN AUI DEVICE BUT THEN EXPIRED DURING THIS PROCEDURE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO MIGRATION OF THE STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death; Rupture

  MAUDE report 7353686 ↗

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-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