ENDURANT® ENEW1313C82ERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994762153), received between Nov 10, 2017 and Nov 10, 2017 — classified as 1 injury.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2017Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT CONTACTED TECHNICAL SERVICES TO REPORT THAT SHE HAD RECEIVED A CARD IN THE POST ABOUT HER IMPLANTED DEVICE. UNTIL THIS TIME, THE PATIENT STATES SHE HAD NO KNOWLEDGE THAT SHE HAD HAD STENT GRAFTS IMPLANTED IN HER, NEITHER DID SHE KNOW THAT FOLLOW UP WAS NEEDED FOR THEM. PATIENT REPORTED THAT SHE HAD BEEN TREATED ALREADY FOR AN ENDOLEAK THAT HAS OCCURRED AND IS SCHEDULED FOR THE REPAIR OF ANOTHER ENDOLEAK WITH A DIFFERENT PHYSICIAN TO THE ORIGINAL PHYSICIAN WHO IMPLANTED THE DEVICE. PATIENT STATES THAT SHE HAD SYMPTOMS THAT "KEPT ME IN BED" SINCE APPROXIMATELY 4 YEARS POST INDEX PROCEDURE AND THIS LED TO THE ENDOLEAK REPAIR. ACCORDING TO THE IMPLANTING PHYSICIAN, THE PATIENT WAS LOST TO FOLLOW UP. A CT HAD REVEALED THAT THE ANEURYSM WAS GETTING LARGER AND THE PATIENT WAS REFERRED TO ANOTHER FACILITY TO TREAT WHAT MAY HAVE BEEN A TYPE II ENDOLEAK. THE IMPLANTING PHYSICIAN HAS NOT SEEN THE PATIENT SINCE THAT TIME AND THEREFORE CANNOT PROVIDE ANY INFORMATION REGARDING THE ALLEGED NEW ENDOLEAK. NO OTHER CLINICAL SEQUELAE WERE REPOR

  Patient problems: Injury

  MAUDE report 7016901 ↗

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-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-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 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