Endurant® II ETLW1610C146E (UDI 00763000388966)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000388966), received between Jun 15, 2021 and Sep 25, 2026 — classified as 5 injuries, 1 malfunction.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Leak/Splash

  It was reported that an endoleak was identified on a follow-up CT scan performed approximately four 4 post-index procedure. The source of the endoleak could not be determined from the CT scan; therefore, the patient underwent angiographic evaluation. Multiple angiograms were performed to assess the source of the endoleak and to rule out Type II, Type Ia, and Type Ib endoleaks. According to the physician, the endoleak was believed to be associated with a tear in the graft fabric involving the left limb stent graft ; however, the exact location of the defect could not be identified angiographically. The cause of the endoleak is unknown. Tortuous anatomy was noted, while calcification and thrombus were not considered contributing factors. The left limb was relined during after which the endoleak resolved. No further patient consequences were reported.

  Patient problems: Insufficient Information

  MAUDE report 50895063 ↗
• InjuryAug 17, 2023Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE.  IT WAS REPORTED VIA PATIENT SERVICES ONE MONTH POST THE INDEX PROCEDURE, THE PATIENT'S RIGHT ILIAC STENT GRAFT BECAME CRIMPLED AND INTERVENTION WAS PERFORMED. IT WAS STATED THAT THE  PATIENT'S RIGHT LEG/FOOT TURNED PURPLE BEFORE THE STENT ISSUE WAS FIXED. NO CAUSE PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 17564654 ↗
• InjuryFeb 9, 2023Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 50MM AAA .  IT WAS REPORTED ON THE DATE OF A CT, A TYPE IB ENDOLEAK WAS NOTED ON THE LIMB ETLW1610C146E. INTERVENTION WAS PERFORMED THE FOLLOWING DAY AND THE LIMB WAS EXTENDED INTO THE EXTERNAL ILIAC ARTERY. THE TYPE IB ENDOLEAK RESOLVED.  PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY AND DISEASE PROGRESSION.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 16333561 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 68.5MM X 64 ABDOMINAL AORTIC ANEURYSM. AN ENDURANT CUFF AND LIMB WERE THEN IMPLANTED PRESUMABLY FOR THE TREATMENT OF A TYPE IA ENDOLEAK OVER 6 YEARS LATER. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY TO HOSPITAL NEARLY 3 MONTHS LATER, AFTER BEING FOUND UNCONSCIOUS ON THE FLOOR. A CT SHOWED A LARGE RUPTURED ABDOMINAL AORTIC ANEURYSM AND WHAT APPEARED TO BE A TYPE IA ENDOLEAK. THE PATIENT WAS TAKEN URGENTLY TO OR FOR CONVERSION TO OPEN REPAIR. IT WAS NOTED AT THIS TIME IN THE PATIENT¿S HISTORY THAT THE PATIENTS RIGHT KIDNEY WAS NOT FUNCTIONAL AS IT WAS TOTALLY ATRETIC AND THE LEFT RENAL ARTERY IS STENOTIC AND JAILED WITH 2 SUPRARENAL EXTENSIONS FROM THE ENDOGRAFT AND THE NEW PROXIMAL EXTENSION. ON THE RIGHT SIDE, THE INTERNAL ILIAC ARTERY IS COILED BECAUSE OF A COMMON ILIAC ANEURYSM AND THE STENT GRAFT EXTENDS INTO THE EXTERNAL ILIAC ARTERY. THERE WAS A VERY LARGE HEMATOMA ANTERIORLY AND IN THE RIGHT RETRO PERITONEUM . IT WAS SAID THE PATIENT PROBABLY HAD A STENT INSERTED INTO THE LEFT ANTERIOR DESCENDING ARTERY AROUND THE TIME OF THE EVAR. DURING THE OPEN CONVERSION

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Ischemia; Rupture

  MAUDE report 13856472 ↗
• InjurySep 24, 2021Obstruction of Flow; Obstruction of Flow

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 47MM ABDOMINAL AORTIC ANEURYSM . THE DIAMETER AT THE RENAL ARTERY WAS NOTED AS 22MM AND THE LENGTH OF THE PROXIMAL NECK NOTED AS 20MM. IT WAS REPORTED ONE DAY POST THE INDEX PROCEDURE FOLLOW UP CT IDENTIFIED THAT THE ENDURANT LIMB (ETLW1610C146E) WAS COMPRESSED AND OCCLUDING BLOOD FLOW. THE NEXT DAY, THE PHYSICIAN INTERVENED AND COMPLETED BILATERAL KISSING STENTS (BARE METAL BALLOON EXPANDABLE) TO SUCCESSFULLY OPEN THE LIMB.  PER THE PHYSICIAN THE CAUSES OF THE COMPRESSION WAS ANATOMY RELATED DUE TO SHORT RENAL TO BIFURCATION. THE RADIAL FORCE OF THE DOUBLE STENT ON THE IPSILATERAL LIMB COMPRESSED THE CONTRA LATERAL LIMB. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12524832 ↗
• MalfunctionJun 15, 2021Defective Component; Defective Component

  AN ENDURANT II STENT GRAFT SYSTEM WAS ATTEMPTED IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 62 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE DEVICE WAS INSERTED, WHERE IT WAS NOTED UNDER FLUOROSCOPY THAT THE PROXIMAL MARKERS OF THE DEVICE WERE NOT T LINED UP IN THE CRIMPED STATE. IT WAS STATED THAT ONE MARKER WAS 3-4 MM LOWER THAT THE OTHER. THE DEVICE WAS THEN REMOVED FROM THE PATIENT AND A ETLW1610C156E WAS THEN USED WITH NO ISSUES. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11999647 ↗

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