ENDURANT® ENLW1624C93ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994761897), received between May 19, 2017 and Feb 19, 2019 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2019Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED ON AN UNKNOWN DATE, CT A TYPE IB ENDOLEAK WAS OBSERVED FROM THE RIGHT CIA WHICH HAD LOST SEAL AND HAS NOW INCREASED IN SIZE. APPROXIMATELY SEVEN YEARS POST THE INDEX PROCEDURE, THE PHYSICIAN COILED THE RIGHT HYPOGASTRIC AND PLACED AN EXTENSION ENDURANT LIMB. ADDITIONALLY, THE PHYSICIAN ELECTED TO IMPLANT AN AORTIC CUFF DUE TO CONCERN FOR A TYPE IA ENDOELAK. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO CONTINUOUS EXPANSION OF THE RIGHT CIA. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8349218 ↗
• InjuryMay 17, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN ABDOMINAL AORTIC DISEASE. IT WAS REPORTED APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE A CT WAS PERFORMED WHICH SHOWED THAT THE RIGHT ILIAC LIMB HAD PULLED OUT OF THE ILIAC AND WAS NOW IN THE AORTA. INTERVENTION WAS PERFORMED. DURING THE INTERVENTION, THE PHYSICIAN SUCCESSFULLY GOT A WIRE THROUGH THE ENDURANT LIMB BUT IT WAS DECIDED THAT THE LIMB WAS AT TOO BAD OF AN ANGLE AND THE WIRE COULD NOT STRAIGHTEN. IT WAS DECIDED TO PLACE AN AUI DEVICE ON THE LEFT SIDE AND OCCLUDE THE RIGHT COMMON ILIAC ARTERY. A FINAL ANGIO WAS PERFORMED AND THERE WAS NO ENDOLEAK. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED WITH THE RIGHT COMMON ILIAC MEASURING 38MM AND THAT AT THE TIME OF IMPLANT, THEY MAY NOT HAVE IMPLANTED FAR ENOUGH INTO THE RIGHT COMMON ILIAC. DUE TO EXPANSION OF THE RIGHT COMMON ILIAC, THE ENDURANT LIMB NOW HAD NOTHING TO ATTACH TO. NO ADDITIONAL CLINICAL SEQUELA WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7521454 ↗
• InjuryMay 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HELI-FX ENDOANCHORS WERE IMPLANTED IN AN ENDURANT STENT GRAFT DURING THE ENDOVASCULAR TREATMENT OF AN 61MM ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK LENGTH WAS OBSERVED TO BE 20MM IN LENGTH, WITH AN AORTIC DIAMETER OF 17.67MM AT 1MM, 16.8MM AT 10MM, 17.67 AT 15MM AND 18.39 AT 20MM BELOW THE LOWEST RENAL ARTERY. THE PROXIMAL AORTIC NECK ANGLE WAS 80 DEGREES. THREE ENDOANCHORS WERE IMPLANTED DUE TO A CONCERN FOR LATE FAILURE. IT WAS REPORTED THAT APPROXIMATELY 6 YEARS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED PULMONARY ISSUES, SPECIFICALLY HYPOXEMIA. THE EVENT RELATIONSHIP WAS DETERMINED TO BE UNCERTAIN. THE PATIENT WAS GIVEN OXYGEN AT HOME AS TREATMENT. THE EVENT WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Hypoxia

  MAUDE report 7498087 ↗
• InjuryNov 14, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL APPROXIMATELY 6 YEARS AND 2 MONTHS POST INDEX PROCEDURE WITH ABDOMINAL PAIN. A CT SCAN SHOWED THAT THE ANEURYSM HAS GROWN FROM 5.5 CM TO 8.6CM A PROXIMAL TYPE I ENDOLEAK AND A DISTAL TYPE I ENDOLEAK WAS ALSO NOTED ON THE RIGHT. THE LEFT APPEARED TO HAVE A SEAL. THE PHYSICIAN IMPLANTED A 36X36X49 ENDURANT CUFF PROXIMALLY AND A 16X24X93 ENDURANT RIGHT SIDE EXTENSION DISTALLY. THE PROXIMAL ENDOLEAK HAS RESOLVED WITH THE CUFF PLACEMENT. THE RIGHT SIDE EXTENSION WAS PLACED WITH A SMALL RESIDUAL ENDOLEAK THAT WAS BALLOONED MULTIPLE TIMES. THE ENDOLEAK IMPROVED BUT THE DECISION WAS MADE TO HAVE A FOLLOW UP CT SCAN AFTER DISCHARGE. A RETROGRADE ANGIOGRAM WAS DONE ON THE LEFT SIDE AND NO ENDOLEAK WAS VISUALIZED. IT WAS REPORTED THAT THE PHYSICIAN CONFIRMED THAT, POST RE-INTERVENTION, THE PATIENT WAS NO LONGER HAVING ABDOMINAL PAIN OR TENDERNESS. PER THE PHYSICIAN THE EVENT WAS ANATOMY RELATED (DISEASE PROGRESSION). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT FINE.

  Patient problems: Pain

  MAUDE report 7028187 ↗
• InjuryMay 19, 2017Adverse 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 AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT RETURNED FOR FOLLOW-UP AND THE CT SHOWED THERE WAS DISEASE PROGRESSION OF THE ILIAC ARTERY ON THE RIGHT SIDE. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY RELATED, DUE TO A 4CM ILIAC ANEURYSM BELOW THE EXISTING ENDURANT LIMB ON RIGHT SIDE OF PATIENT. THE DECISION WAS MADE TO COIL THE HYPOGASTRIC ARTERY ON THE RIGHT SIDE AND EXTEND WITH AN ENDURANT STENT GRAFT AND THIS SUCCESSFULLY RESOLVED THE EVENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm

  MAUDE report 6579118 ↗

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