Endurant® IIs ESBF3214C103E (UDI 00763000306342)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000306342), received between Apr 23, 2021 and Mar 24, 2022 — classified as 2 deaths.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN 80MM RUPTURED ABDOMINAL AORTIC ANEURYSM .  IT WAS REPORTED THE EVAR WAS PERFORMED AS PLANNED BUT THE PATIENT DID NOT SURVIVE THE OPERATION. AS PER THE PHYSICIAN THE CAUSE OF THE DEATH WAS THE RUPTURED ANEURYSM AND EMERGENT EVAR. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Rupture

  MAUDE report 13891276 ↗
• DeathApr 23, 2021Leak/Splash; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A 67MM RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT WAS BECOMING UNSTABLE WHEN ARRIVING TO THEATRE, THE PHYSICIAN MANAGED TO SEAL THE ANEURYSM. IT WAS REPORTED THAT AS PER MANAGEMENT OF A RUPTURE PROTOCOL, THE MAIN BODY BIFURCATION WAS MOVED IN THE 12MM CONICAL NECK AND ONLY HALF OF THAT SEAL LENGTH WAS OBTAINED SEQUENTIALLY PRODUCING A SMALL TYPE IA ENDOLEAK. AN ENDURANT CUFF ALONG WITH 6 HELI-FX ENDOANCHORS WERE THEN IMPLANTED TO TREAT THE IA ENDOLEAK. IT WAS REPORTED THE PATIENT EXPIRED EARLY THE FOLLOWING DAY. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS WAS CONSIDERED THAT THE PATIENT HAD ARRIVED TOO LATE INTO HOSPITAL AND THAT THE COAGULATION CASCADE WAS TOO FAR ALONG, WHEN AN EXPLORATORY LAPAROTOMY WAS PERFORMED FOR DECOMPRESSION OF THE ABDOMEN, A SEVERE DISEASED LIVER WAS ALSO OBSERVED. IT WAS REPORTED THE PHYSICIAN WAS HAPPY WITH THE PERFORMANCE OF THE STENT GRAFTS BUT IT WAS NOTED THAT THESE TYPES OF PATIENTS USUALLY DON'T RECOVER FROM THIS TYPE OF INSULT. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT HAS EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 11715752 ↗

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-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-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-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-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-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