Endurant® II ETUF2314C102ERecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169232556), received between Jun 23, 2017 and Mar 9, 2026 — classified as 3 deaths, 8 injuries.

The most frequently reported specific device problem is “Leak/Splash” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 21, 2021Class IIOpen, Classified

   Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.

   Z-0657-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2026Difficult to Insert; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM (54 MM) REPAIR USING THE STENT GRAFT ETUF2314C102E ENDUR II AUI, INSERTION DIFFICULTIES WERE ENCOUNTERED WHEN PASSING THROUGH A SELF-EXPANDABLE STENT THAT HAD BEEN PREVIOUSLY DEPLOYED IN THE FEMORAL ARTERY. AFTER COMPLETE DEPLOYMENT OF THE AUI STENT GRAFT, THE DELIVERY SYSTEM BECAME STUCK DURING REMOVAL AFTER GETTING CAUGHT IN THE FEMORAL ARTERY STENT. INTERVENTION WAS PERFORMED VIA CONVERSION FROM THE ENDOVASCULAR PROCEDURE TO AN OPEN ABDOMINAL AORTICANEURYSM REPAIR IN WHICH THE AUI STENT GRAFT WAS EXPLANTED AND THE EVENT WAS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENTS WAS DUE TO ANATOMICAL CHALLENGES, SPECIFICALLY PREVIOUS STENTED FEMORAL ARTERY WITH TORTUOUS ANATOMY. PRE IMPLANT SIZING SHOWED THEPROXIMAL NECK AS ANGLED WITH MILD THROMBUS AND CALCIFICATION. MODERATE BILATERAL ILIAC CALCIFICATION WAS ALSO NOTED.

  Patient problems: Insufficient Information

  MAUDE report 24543038 ↗
• DeathOct 31, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE TO TREAT A 51 MM ABDOMINAL AORTIC ANEURYSM, THE PATIENT PRESENTED WITH NARROW ACCESS AND DIFFUSED CALCIFICATION IN THE COMMON ILIAC ARTERIES, AS WELL AS SIGNIFICANT CIRCUMFERENTIAL CALCIFICATION AND VESSEL NARROWING IN THE DISTAL AORTA. BALLOON ANGIOPLASTY WITH 8 MM DIAMETERS WAS PERFORMED TO BREAK UP CALCIFICATION AND DILATE THE RIGHT COMMON ILIAC. THE STENT GRAFT ETUF2314C102E ENDUR II AUI WAS INSERTED ON A STIFF WIRE "BAREBACK" BUT COULD NOT PASS THE ADDITIONAL NARROWING IN THE DISTAL AORTA. THE DEVICE WAS REMOVED AND SUBSEQUENTLY DELIVERED THROUGH AN 18 FRENCH SHEATH, WHICH WAS LATER DETERMINED TO HAVE MOST LIKELY CAUSED PERFORATIONS IN MULTIPLE PLACES IN THE COMMON ILIAC AND/OR PROXIMAL EXTERNAL ILIAC ARTERY. AT THAT MOMENT, A BLOOD PRESSURE DROP INDICATED VESSEL PERFORATION , AND THE 18FR SHEATH WAS ADVANCED INTO THE DISTAL AORTA TO OCCLUDE THE PERFORATION. THE ENDURANT II AUI STENT GRAFT WAS SUCCESSFULLY DEPLOYED IN THE AORTA THROUGH THE SHEATH. A NON MDT STENT WAS DEPLOYED FROM THE DISTAL END OF THE AUI INTO THE RIGHT COMMON ILIAC TO COVER THE PERFORATION THAT LOOKED LOCALIZED TO THE PROXIMAL COMMON ILIAC ARTERY. ONCE THE NON

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 23434977 ↗
• DeathNov 18, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA AND ENDURANT STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 58 MM THORACIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, VAMF4646C200TU WAS ADVANCED TO THE THORACIC AORTA WITH SOME RESISTANCE BUT PLACED SUCCESSFULLY. UPON REMOVAL OF THE DELIVERY SYSTEM, FEMORAL ARTERY TISSUE WAS SEEN ON THE DELIVERY CATHETER. A 20FR SHEATH WAS INSERTED AND BLOOD PRESSURE WAS STABLE FOR A MOMENT AND THEN DROPPED SO BALLOON OCCLUSION WAS PERFORMED. DUE TO RIGHT ILIOFEMORAL ARTERY DAMAGE/EVULSION THE PHYSICIANS ELECTED TO DIRECT FLOW FROM THE ABDOMINAL AORTA TO THE RIGHT FEMORAL HEAD THROUGH THE AREA OF THE INJURY WITH AND ENDURANT 23 MM AUI AND 10 MM LIMBS TO BE FOLLOWED WITH A RIGHT TO LEFT FEM- FEM GRAFT . ONCE THE AUI AND LIMBS WERE IN PLACE, BALLOON OCCLUSION WAS RELEASED. THE PATIENTS BP CONTINUED TO DROP AND A RETROGRADE ANGIOGRAM THE RIGHT REVEALED A DISUNION BETWEEN ETLW16010C124E AND ETEW1010C82E. BALLOON OCCLUSION WAS ESTABLISHED VIA THE LEFT SIDE (BEHIND THE AUI). IN ORDER TO MAINTAIN BP WHILE WORKING ON THE RIGHT. AN ETEW1313C82E WAS PLACED TO BRIDGE THE ENDURANT LIMBS WITH A NON MDT 12 MM X 38 MM COVERED STENT TO SECURE IT. BALLOON OCCLUSION I

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 15824274 ↗
• InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ENDURANT STENT GRAFTS ETUF2314C102, ETLW1616C146E AND ETLW1613C82E WERE IMPLANTED FOR THE TREATMENT OF THROMBUS IN THE PREVIOUSLY IMPLANTED ESBF2314C103E AND ETLW1616C124E DEVICES (APPROXIMATELY 3 YEARS PREVIOUS). A FEM FEM BYPASS WAS ALSO COMPLETED DURING THE ORIGINAL INDEX PROCEDURE. APPROXIMATELY 2 YEARS POST THE ORIGINAL INDEX PROCEDURE INTERVENTION WAS COMPLETED FOR THROMBUS AND OCCLUSION AND THE PATIENT HAD BEEN ON ANTI-COAGULATION MEDICATION SINCE THIS TIME. APPROXIMATELY 3 YEARS POST THE ORIGINAL INDEX PROCEDURE THE PATIENT PRESENTED WITH RIGHT LEG PAIN AND ANGIOGRAM SHOWED EVIDENCE OF THROMBUS WITHIN THE PREVIOUSLY IMPLANTED ESBF2314C103E AND ETLW1616C124E DEVICES AND ETUF2314C102, ETLW1616C146E AND ETLW1613C82E WERE IMPLANTED. THROMBECTOMY WAS PERFORMED ON THE SAME DAY, THE ESBF2314C103E AND ETLW1616C124E WERE RE-LINED WITH AN ETUF2314C102 AND ETLW1616C146E WITH THE PLACEMENT OF AN ETLW1613C82E TO EXTEND INTO THE EXTERNAL RIGHT ILIAC. THROMBECTOMY WAS ALSO PERFORMED ON THE PREVIOUS FEMORAL-FEMORAL BYPASS AND FEMORAL-POPLITEAL BYPASS. DURING THE ANGIOGRAM POST IMPLANT OF THE ETUF2314C102E IT WAS NOTED THAT THE LEFT RENAL ARTERY APPEARED TO BE OCCLUDED, THROMBECTOMY WAS PER

  Patient problems: Numbness; Obstruction/Occlusion; Pain

  MAUDE report 12405513 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A OCCLUSIVE DISEASE AND SMALL ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 1 1/2 MONTHS POST PROCEDURE, THE PATIENT RETURNED FOR FOLLOW-UP WITH COMPLAINTS OF PAIN, WHERE IT WAS DISCOVERED THAT THE STENT GRAFT HAD THROMBOSED. THE EVENT WAS TREATED WITH AX-FEM BYPASS AND OPEN-SURGERY. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS A POSSIBLE CLOTTING DISORDER. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12058317 ↗
• InjuryApr 27, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II AUI STENT GRAFT WAS IMPLANTED ALONG WITH AN ENDURANT LIMB AND A NON-MDT CHIMNEY GRAFT IN THE ENDOVASCULAR TREATMENT OF A MAXIMUM DIAMETER 59.6MM ABDOMINAL AORTIC ANEURYSM. THERE WAS NOTED TO BE SEVERE PROXIMAL NECK TORTUOSITY WITH LOCALIZED THROMBUS AND CALCIUM AT THE PROXIMAL SEAL ZONE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE 6 ENDOANCHORS WERE IMPLANTED TO THE PROXIMAL NECK DUE TO AN OBSERVED TYPE IA ENDOLEAK. THIS SUCCESSFULLY RESOLVED THE ENDOLEAK. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 10000857 ↗
• InjuryOct 1, 2019Leak/Splash; Leak/Splash

  AN ENDURANT AUI STENT GRAFT SYSTEM WAS IMPLANTED IN PATIENT FOR ENDOVASCULAR TREATMENT OF A 50 MM ABDOMINAL AORTIC ANEURYSM. CALCIFICATION WAS NOTED. IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER THE AUI STENT AND EXTENSION LIMB WAS DEPLOYED SUCCESSFULLY THE FINAL ANGIOGRAM IDENTIFIED A SIGNIFICANT TYPE IA OR TYPE III ENDOLEAK. AS THERE WAS SOME ROOM TO EXTEND AN AORTIC CUFF WAS DEPLOYED. A REPEAT ANGIOGRAM WAS PERFORMED HOWEVER THE ENDOLEAK WAS STILL PRESENT WITH NO IMPROVEMENT NOTED. A RELIANT BALLOON WAS THEN INFLATED IN THE PROXIMAL ATTACHMENT WITH THE PIGTAIL IN THE BODY OF THE GRAFT. ANOTHER ANGIOGRAM WAS COMPLETED WHICH CONFIRMED THE ENDOLEAK WAS A TYPE IIIB. A 24 MM LIMB EXTENSION WAS USED TO BRIDGE THE PROXIMAL ATTACHMENT TO THE LIMB EXCLUDING THE SUSPECT AREA OF THE TYPE IIIB ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE TYPE IIIB ENDOLEAK CANNOT BE DETERMINED BUT COMMENTED THAT THERE APPEARED TO BE A BREACH IN THE MID GRAFT BODY THAT THE CALCIFIED ANATOMY MAY HAVE CONTRIBUTED TO. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9138808 ↗
• InjuryJan 3, 2018Leak/Splash; Leak/Splash

  AN ENDURANT AUI STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 68 MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE ONCE THE STENT GRAFT WAS IMPLANTED AN ANGIOGRAM WAS PERFORMED AND A TYPE III ENDOLEAK WAS OBSERVED. A 25MM AORTIC EXTENSION (ETCF2525C49E) WAS PLACED FROM BELOW THE RIGHT RENAL ARTERY DOWN 23MM INTO THE AUI THE NEXT DAY. THE TYPE III ENDOLEAK WAS RESOLVED POST INTERVENTION. THE CAUSE OF THE EVENT REMAINS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7160475 ↗
• InjuryOct 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 52MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, WHILE REMOVING THE DELIVERY SYSTEM, THE EXTERNAL ILIAC WAS PERFORATED. THE PHYSICIAN PERFORMED AN INTERVENTION AND A BYPASS GRAFT WAS SEWN IN FROM THE RIGHT PROXIMAL COMMON ILIAC TO THE RIGHT FEMORAL ARTERY, RESOLVING THE EVENT. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO THE PATIENT'S ANATOMY; NARROW ILIAC ARTERIES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Perforation of Vessels

  MAUDE report 6948021 ↗
• DeathSep 28, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY. THE STENT GRAFT WAS THROMBOSED SO AN INTERVENTION WAS PERFORMED TO EXPLANT THE GRAFT. DURING THE SECONDARY PROCEDURE, THE PATIENT EXPIRED FROM HYPERKALEMIA AND RHABDOMYOLYSIS. PER THE PHYSICIAN, THE PATIENT WAS A HEAVY SMOKER THAT CONTINUED TO SMOKE POST GRAFT IMPLANT WHICH MOST LIKELY CAUSED THE THROMBOSIS.

  Patient problems: Death; Occlusion

  MAUDE report 6899952 ↗
• InjuryJun 23, 2017Malposition of Device; Malposition of Device

  AN ENDURANT AUI STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT A 5.4 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. PATIENT HAS SMALL CALCIFIED ARTERIES. IT WAS REPORTED THAT AFTER THE DEPLOYMENT THE ENDURANT AUI STENT GRAFT THE DEVICE CONTINUED TO MOVE PROXIMALLY MULTIPLE TIMES. THE PHYSICIAN PULLED THE DEVICE TO THE INTENDED LANDING ZONE. A FINAL ANGIOGRAM WAS PERFORMED THERE WAS A FULL VIEW OF THE RENAL ARTERY AND THE MARKERS WERE NOT COVERING THE RENAL ARTERIES. THE PATIENT¿S CREATININE LEVEL WENT FROM 0.7 TO 5. THE CT REVEALED THAT THE ENDURANT AUI WAS COVERING THE RENAL ARTERY. THE PHYSICIAN ATTEMPTED BUT WAS UNABLE TO ACCESS THE RENAL ARTERY. THE PATIENT WAS NOT PRODUCING URINE DAYS LATER. THE PATIENT WAS SENT TO DIALYSIS. PER THE PRIMARY PHYSICIAN, THE CAUSES OF THE EVENTS ARE DUE TO THE PATIENT¿S ANATOMY, SMALL CALCIFIED ARTERIES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED BY THE PHYSICIAN.

  Patient problems: Occlusion; Renal Failure

  MAUDE report 6664055 ↗

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-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