ENDURANT® ENBF2316C145ERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994762290), received between May 12, 2017 and Jul 26, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (3 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.

• InjuryJul 26, 2021Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 52 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A ROUTINE CT PERFORMED UNDER 10 YEARS LATER SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK AND A IB ENDOLEAK ON THE ENDURANT LIMB (B)(4). INTERVENTION WAS PERFORMED ABOUT A MONTH LATER. AN ENDURANT CUFF AND ENDOANCHORS WERE IMPLANTED, WHICH RESOLVED THE IA ENDOLEAK. FOLLOWING THIS, AN ATTEMPT WAS MADE TO REPAIR THE IB ENDOLEAK. THE PHYSICIAN DID NOT HAVE CONSENT TO COIL AND COVER THE LEFT HYPOGASTRIC ARTERY SO THE PHYSICIAN EXTENDED WITH AN ETLW1620C93E ENDURANT LIMB BUT THIS PROVED UNSUCCESSFUL AND THE IB ENDOLEAK REMAINED. AS PER THE PHYSICIAN THE CAUSE OF THE IA ENDOLEAK COULD NOT BE DETERMINED. THE CAUSE OF THE IB ENDOLEAK WAS STATED TO BE AS A RESULT OF CONTINUED ANEURYSMAL DISEASE OF THE ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 12223483 ↗
• InjuryOct 17, 2018Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM.. APPROXIMATELY SIX YEARS LATER, A TYPE IA ENDOLEAK WAS OBSERVED DURING A FOLLOW UP CT. IT WAS REPORTED THE STENT GRAFT WAS 1CM FROM THE LEVEL OF THE LOWEST RENAL BUT THE PHYSICIAN REPORTED THERE WERE NO PREVIOUS FILMS SO HE WAS UNABLE TO TELL IF THE GRAFT HAD MIGRATED. AN INTERVENTION PROCEDURE WAS CARRIED OUT APPROXIMATELY TWO WEEKS LATER TO TREAT THE ENDOLEAK. AN ENDURANT CUFF WAS IMPLANTED UP TO THE LEVEL OF THE LOWEST RENALS. FOUR ENDOANCHORS WERE ALSO PLACED AT THE PROXIMAL END OF THE CUFF TO ENSURE GOOD SEAL. THE EVENT IS REPORTED TO BE RESOLVED WITH NO SIGN OF THE TYPE IA ENDOLEAK ON THE ANGIOGRAM CARRIED OUT AT THE END OF THE PROCEDURE. THE PHYSICIAN REPORTED THE CAUSE OF THE EVENT TO BE PROGRESSIVE NECK DILATION. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7973851 ↗
• MalfunctionMay 12, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.6 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE VESSEL MORPHOLOGY WAS REPORTED THE PROXIMAL AORTA WAS 21-19-20 MM IN DIAMETER. THE RIGHT ILIAC ARTERY WAS 18 MM IN DIAMETER AND THERE WAS 20 MM BETWEEN THE BIFURCATION AND THE RIGHT HYPOGASTRIC ARTERY. THE LEFT ILIAC ARTERY WAS 16-17 MM IN DIAMETER. THE FEMORAL ARTERIES WERE 7-8 MM IN DIAMETER. IT WAS REPORTED THAT A RECENT CT REVEALED THAT THERE WAS A POSSIBLE TYPE III FABRIC ENDOLEAK IN THE ENDURANT STENT GRAFT BIFURCATE OR A POSSIBLE TYPE II ENDOLEAK. THERE WAS CONTRAST OBSERVED AT THE LEVEL OF THE FLOW DIVIDER NEAR THE ORIGIN OF THE INFERIOR MESENTERIC ARTERY AND LUMBAR ARTERIES. CURRENTLY THE ANEURYSM IS 6.4 CM IN DIAMETER. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THE PHYSICIAN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6563832 ↗

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 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