ENDURANT® ENBF2820C145ERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994762467), received between Oct 24, 2017 and Feb 23, 2022 — classified as 2 injuries, 1 malfunction.

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.

• MalfunctionFeb 23, 2022Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATED STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM .  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN AND A CT TAKEN SHOWED EVIDENCE OF A TYPE IA ENDOLEAK AND THE AAA SAC IS NOW MEASURING 83MM.  AS PER THE PHYSICIAN THE TYPE IA ENDOLEAK WAS DUE TO THE PATIENTS OWN ANATOMY AS A RESULT OF DISEASE PROGRESSION WHICH CAUSED THE LOSS OF SEAL.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13583349 ↗
• InjuryDec 16, 2019Adverse 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 A >30MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY IN ABDOMINAL PAIN APPROXIMATELY SEVEN YEARS LATER AND AN ENLARGING RIGHT COMMON ILIAC AORTIC ANEURYSM WAS IDENTIFIED. THE PATIENT RECEIVED TREATMENT WITH EMBOLISATION OF THE RIGHT HYPOGASTRIC ARTERY AND AN EXTENSION LIMB ON THE RIGHT AS FAR AS THE RIGHT EIA. THE LEFT SIDE WAS EXTENDED ALSO AS FAR AS THE LEFT HYPOGASTRIC. THE EVENT WAS RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm

  MAUDE report 9472246 ↗
• InjuryOct 24, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT WAS NOT COMPLAINT WITH FOLLOW UP APPOINTMENTS. A RECENT CT REVEALED THAT THERE WAS A THERE WAS GOOD PROXIMAL SEAL ALL THE WAY UP TO THE LOWEST RENAL ARTERY HOWEVER THERE IS A DISTAL TYPE IB ENDOLEAK ON THE RIGHT, IPSILATERAL SIDE AND THERE WAS LOSS OF STENT GRAFT SEAL ON THE LEFT, CONTRALATERAL SIDE. THERE WAS ALSO A3CM SACCULAR ANEURYSM NOTED AT THE DISTAL RIGHT COMMON ILIAC. PER THE INVESTIGATOR, THE DISTAL TYPE I ENDOLEAK AND THE LOSS OF SEAL ARE RELATED TO THE PATIENT¿S ANATOMY, DILATATION OF THE ILIAC LIMB. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THE PHYSICIAN. IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED TO FIX AT TYPE IB ENDOLEAK ON THE RIGHT LIMB. IT WAS NOTED THAT THE LEFT LIMB ONLY HAD 5 MM OF SEAL BEFORE IT COULD BE PULLED UP INTO THE ANEURYSMAL SAC ALSO. DURING THE PROCEDURE, A LEFT EXTENSION LIMB WAS IMPLANTED WITHOUT ISSUE. WHILE ATTEMPTING TO DEPLOY THE RIGHT EXTENSION LIMB, AN ISSUE OCCURRED WITH THE FULL DEPLOYMENT OF THE STENT GRAFT. THE PHYSICIAN WA

  Patient problems: Injury

  MAUDE report 6970963 ↗

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 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