Endurant® II ETLW1613C93E (UDI 00613994991539)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994991539), received between May 9, 2017 and Sep 30, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 18, 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.

• InjurySep 30, 2024Leak/Splash; Leak/Splash

  AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 60MM AAA. AN ENDURANT CUFF ETCF2828C49E WAS IMPLANTED 10 YEARS AND FIVE MONTHS LATER DUE TO A TYPE IA ENDOLEAK WHICH WAS IDENTIFIED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY THE FOLLOWING MONTH AND A IB ENDOLEAK WAS OBSERVED IN THE LEFT ILIAC LIMB ETLW1613C93E . INTERVENTION WAS PERFORMED ON THE SAME DAY AND A LIMB EXTENSION WAS IMPLANTED. THIS RESOLVED THE IB ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE IB ENDOEAK WAS ANATOMY RELATED DUE TO ILIAC DISEASE PROGRESSION. NO CAUSE OF THE IA ENDOLEAK WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 20331549 ↗
• MalfunctionAug 12, 2024Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN AAA. IT WAS REPORTED APPROXIMATLEY 9 YEARS POST THE INDEX PROCEDURE, THAT THE PATIENT PRESENTED TO THE ER WITH ABDOMINAL PAIN AND A CT SHOWED A IA ENDOLEAK AND BILATERAL IB ENDOLEAKS. BOTH LIMBS HAVE MIGRATED INTO THE ANEURYSM SAC. NO FUTURE REPAIR IS PLANNED AS THE FAMILY CHOSE PALLIATIVE CARE. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO AORTIC DEGENERATION AND REMODELING. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Abdominal Pain

  MAUDE report 19960271 ↗
• MalfunctionJan 3, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A CT EXAM PERFORMED APPROXIMATELY 2 YEARS POST IMPLANT, THE PATIENTS RIGHT ILIAC ARTERY DIAMETER MEASURED BETWEEN 12.7-13MM.THE CT EXAM ALSO REVEALED A TYPE IB ENDOLEAK ON THE RIGHT SIDE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THE PHYSICIAN.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 7159517 ↗
• MalfunctionNov 29, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 67MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 3 MONTHS POST INDEX PROCEDURE, ON FOLLOW UP CT, THE PHYSICIAN WAS CONCERNED ABOUT THE POSSIBLE PRESENCE OF A TYPE IA ENDOLEAK. A TYPE IB ENDOLEAK WAS SUSPECTED WITHIN (B)(4). AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS DUE TO ANATOMY AS THE INFRARENAL AORTA AND RIGHT COMMON ILIAC APPEAR TO HAVE DILATED SINCE THE INITIAL IMPLANT OF THE STENT GRAFTS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THE PHYSICIAN

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 7066179 ↗
• InjuryMay 9, 2017Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT HAD FALLEN AND HIT THEIR SIDE AND PRESENTED EMERGENTLY TO THE HOSPITAL. CURRENTLY, THE ABDOMINAL AORTIC ANEURYSM IS 7 CM IN DIAMETER. A CT REVEALED BILATERAL DISTAL TYPE I ENDOLEAKS AND THE STENT GRAFTS APPEARED TO HAVE MIGRATED PROXIMALLY. THE ANGIOGRAM CONFIRMED BILATERAL DISTAL TYPE I ENDOLEAKS. THE PHYSICIAN DECIDED TO IMPLANT ENDURANT ILIAC LIMBS BILATERALLY EXTENDING THE ILIAC LIMBS INTO THE COMMON ILIAC ARTERIES. THE BILATERAL DISTAL TYPE I ENDOLEAKS WERE RESOLVED. THE PHYSICIAN STATED THAT THE CAUSE OF THE BILATERAL DISTAL TYPE I ENDOLEAKS AND LIMB MIGRATION WERE RELATED TO THE PATIENT¿S ANATOMY OF CONTINUED DISEASE PROGRESSION OF THE COMMON ILIAC ARTERIES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6555942 ↗

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