Endurant® II ETLW1620C146E (UDI 00763000519964)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000519964), received between Apr 12, 2023 and May 28, 2026 — classified as 4 injuries, 3 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 90MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT IDENTIFIED A TYPE IB ENDOLEAK IN ETLW1620C146E ((B)(6)). INTERVENTION WAS COMPLETED. AN INITIAL ANGIOGRAM CONFIRMED A TYPE IB ENDOLEAK. A CATHETER WAS PLACED BEHIND THE GRAFT INTO THE ABDOMINAL AORTIC ANEURYSM SAC AND THE SAC WAS EMBOLIZED USING NON MDT (PENUMBRA COILS) AND GLUE. A RIGHT GRAFT LIMB EXTENSION ETLW1620C156E ((B)(6) WAS THEN IMPLANTED. AN INJECTION THROUGH THE SHEATH AGAIN SHOWED A TYPE IB ENDOLEAK. AFTER DISCUSSION, THE RIGHT HYPOGASTRIC ARTERY WAS EMBOLIZED AND THE RIGHT GRAFT LIMB WAS EXTENDED AND RELINED INTO THE PROXIMAL RIGHT EXTERNAL ILIAC ARTERY WITH ETLW1613C156E & ETLW1616C146E AND THE ENDOLEAK WAS CONFIRMED AS RESOLVED. PER THE PHYSICIAN THE CAUSE WAS DUE TO ANATOMY, SPECIFICALLY DILATATION OF THE RIGHT COMMON ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 25315803 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF AAA. ON CT APPROXIMATELY 2.5 MONTHS POST INDEX PROCEDURE, THROMBUS WAS IDENTIFIED NEAR THE VERY DISTAL ASPECT OF THE RIGHT ILIAC LIMB ETLW1620C146E (B)(6), WITH EXTENSION INTO THE NATIVE EXTERNAL ILIAC ARTERY. THERE WAS NO ISSUE WITH THE ENDURANT BIFURCATE. THE INDIVIDUAL WAS OTHERWISE ASYMPTOMATIC AND REPORTED TO BE DOING WELL. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO THE DEVICE. THE INDIVIDUAL WAS RECOMMENDED TO START A COURSE OF XARELTO, WITH A PLAN FOR ANOTHER FOLLOW-UP VISIT THREE MONTHS LATER.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22802400 ↗
• MalfunctionMar 12, 2024Use of Device Problem; Use of Device Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE THE CONTRALATERAL GATE OF THE BIFURCATE WAS CANULATED AND THE PHYSICIAN REQUESTED A 16X20X146 LIMB FOR THE CONTRALATERAL SIDE. ETLW1620C146E; (B)(6) WAS OPENED AND IMPLANTED. AFTER THE LIMB WAS IMPLANTED THE CIRCULATING NURSE DISCOVERED THAT THE STENT GRAFT'S EXPIRATION DATE WAS 23-FEB-2024 AND INFORMED THE PHYSICIAN. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES AND THE ANEURYSM TOTALLY EXCLUDED. THE CAUSE OF IMPLANTING THE EXPIRED GRAFT WAS THE EXPIRATION DATE WAS DISCOVERED AFTER THE GRAFT WAS IMPLANTED. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884922 ↗
• InjuryFeb 7, 2024Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT LIMB (ETLW1620C146E) WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 62MM ABDOMINAL AORTIC ANEURYSM . IT WAS NOTED THAT THE LENGTH OF THE PROXIMAL AORTIC NECK AT IMPLANT WAS 60MM AND THE DIAMETER OF AORTA AT RENAL ARTERY WAS NOTED AS 29MM. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE ENDURANT II LIMB WAS SUCCESSFULLY IMPLANTED. HOWEVER, CT SCAN REVEALED THAT THE STENT GRAFT LIMB HAD THREE SEPARATE TYPE III ENDOLEAKS. THERE WAS NO EXCESSIVE BALLOONING AND NO DIFFICULTIES WERE ENCOUNTERED DURING THE IMPLANT PROCEDURE. AS TREATMENT, THE LIMB WAS RELINED WITH ANOTHER STENT GRAFT. PER THE PHYSICIAN THE CAUSE OF THE TYPE III ENDOLEAK COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 18659176 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 76MM RUPTURED AAA .   IT WAS REPORTED THAT 6 MONTHS LATER , THE PATIENT COMPLAINED OF LEFT LIMB CLAUDICATION AND IT WAS FOUND THAT THE LEFT LIMB STENT GRA FT ETLW1620C146E E WAS OCCLUDED. ABOUT 3 MONTHS LATER , A RIGHT TO LEFT FEMORAL TO FEMORAL BYPASS WAS PERFORMED AS TREATMENT TO RESOLVE THE OCCLUSION.  PER THE PHYSICIAN THE CAUSE OF THE OCCLUSION WAS ANATOMY. IT WAS SAID THE PATIENTS PRE-EXISTING PERIPHERAL ARTERY DISEASE WAS WORSE ON THE LEFT SIDE AND IT IS BELIEVED THIS CAUSED AN OUTFLOW ISSUE WITH LED TO THE THROMBOSIS OF THE ENDURANT LIMB.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 18285401 ↗
• MalfunctionJun 6, 2023Difficult to Remove; Malposition of Device; Difficult to Remove; Malposition of Device

  AN ENDURANT II STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA. IT WAS REPORTED DURING THE INDEX PROCEDURE, AN ILIAC LIMB ETLW1620C146E WAS DEPLOYED UNDER FLUOROSCOPIC GUIDANCE. THE LIMB HAD BEEN COMPLETELY DEPLOYED BUT AS THE DELIVERY SYSTEM WAS BEING REMOVED , IT GOT CAUGHT ON THE PROXIMAL LEADING EDGE FABRIC . ATTEMPTS WERE MADE TO DISLODGE THE TAPERED TIP, THE DEVICE PULLED DOWN BY ABOUT 5MM. THE CONE WAS ULTIMATELY  FREED FROM THE FABRIC AND THE DELIVERY SYSTEM WAS REMOVED. THERE WAS NO INJURY TO THE PATIENT.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17069585 ↗
• MalfunctionApr 12, 2023Difficult to Insert; Deformation Due to Compressive Stress; Difficult to Insert; Deformation Due to Compressive Stress

  AN ENDURANT II LIMB WAS INTENDED TO BE IMPLANTED AS PART OF THE ENDOVASCULAR TREATMENT OF A 50MM AAA . IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN WAS LOADING THE DELIVERY SYSTEM OVER A .035 NON MDT WIRE AND THE WIRE WOULD NOT FULLY ADVANCE THROUGH THE DEVICE. MULTIPLE ATTEMPTS OF RE FLUSHING THE WIRE LUMEN AND RE ADVANCING MULTIPLE WIRES THROUGH THE WIRE LUMEN ALL FAILED. UNDER FLUOROSCOPY THE HYPO TUBE WAS CLEARLY VISUALIZED AND KINKED. THE DEVICE WAS NEVER ADVANCED INTO THE PATIENT. ANOTHER STENT GRAFT WAS USED INSTEAD. PER THE PHYSICIAN THE CAUSE OF ISSUE IS A DEFECTIVE DEVICE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16723656 ↗

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-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-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-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