Endurant® II ETBF2313C124ERecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00613994991164), received between Feb 8, 2017 and Aug 25, 2025 — classified as 3 deaths, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

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

5 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 ↗

2. Feb 27, 2017Class IITerminated

   Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific models and serial numbers as this specific subset of stent grafts has greater susceptibility to fabric permeability variations that may be associated with endoleaks observed during the initial implant procedure.

   Z-1543-2017 · Root cause: Packaging change control · Recall details · FDA record ↗

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.

• MalfunctionAug 25, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR AORTIC REPAIR PROCEDURE USING A STENT GRAFT ETBF2313C124E ENDUR II BIF AND BILATERAL LIMBS TO TREAT A 63 MM ANEURYSM, DIFFICULTIES WERE ENCOUNTERED DURING REMOVAL OF THE MAIN BODY STENT GRAFT'S DELIVERY SYSTEM. AFTER DEPLOYMENT OF THE MAIN BODY, THE DELIVERY SYSTEM COULD NOT BE BACKED OUT OVER THE WIRE. WHILE ADVANCING THE DELIVERY SYSTEM BACK INTO THE COMMON FEMORAL ARTERY, A KINK IN THE WIRE WAS IDENTIFIED. THE WIRE WAS THEN CUT PROXIMAL TO THE KINK, ALLOWING THE DELIVERY SYSTEM TO BE REMOVED WITH MINOR DIFFICULTY. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883367 ↗
• DeathFeb 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 53MM SACCULAR AAA .  IT WAS REPORTED DURING THE PROCEDURE, AFTER IMPLANTING THE MAIN BODY AND A LIMB, THE PHYSICIAN BEGAN VERY LIGHTLY BALLOONING THE PROXIMAL NECK SEAL ZONE. WHILE BALLOONING THERE WAS A CHANGE IN DIAMETER OF THE PROXIMAL NECK AND A RUPTURE WAS CONFIRMED. THE PATIENTS BLOOD PRESSURE DROPPED AND SUSTAINED BALLOON INFLATION WAS USED TO MAINTAIN SYSTOLIC PRESSURE. THE PHYSICIAN  THEN OBTAINED LEFT ARM ACCESS AND USED A CHIMNEY TECHNIQUE TO PLACE A NON MDT STENT INTO THE LEFT RENAL ARTERY AND SUBSEQUENTLY PLACED A 25/25/49 AORTIC CUFF TO THE LEVEL OF THE RIGHT RENAL ARTERY.  AFTER BALLOONING,  THE CUFF HELPED SLOW THE EXTRAVASATION IN THE PROXIMAL NECK BUT THE PATIENT CONTINUED TO BE UNSTABLE AND THE PATIENT WAS  CONVERTED TO AN OPEN SURGICAL REPAIR.  PER THE PHYSICIAN THE CAUSE OF THE RUPTURE WAS DUE TO VERY FRIABLE AND CALCIFIED TISSUE IN THE PROXIMAL SEAL ZONE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Ischemia; Low Blood Pressure/ Hypotension; Rupture; Thrombosis/Thrombus

  MAUDE report 16442062 ↗
• InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 6 MONTHS POST THE INDEX PROCEDURE FOLLOW UP CT SHOWED THE PATIENT LOST FLOW TO THE LIMB DUE TO OUTFLOW ISSUES. INTERVENTION WITH A FEM CROSSOVER GRAFT WAS PERFORMED AND THE OCCLUSION RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE OCCLUSION WAS AS THE EXTERNAL ILIAC WAS DISEASED AND NOTED THAT THE GRAFT WAS NOT KINKED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16234005 ↗
• DeathMay 26, 2021Adverse 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 PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN AORTIC ULCER. IT WAS STATED THAT THE PATIENT WAS THROWING THROMBUS BEFORE THE INITIAL PROCEDURE. PATIENT UNDERWENT EVAR TO PREVENT THROMBUS FROM THE INFRARENAL AORTA FROM CONTINUING TO BREAK OFF AND CAUSE ISCHEMIA IN HER LOWER EXTREMITIES. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED ON THE NEXT DAY POST INDEX PROCEDURE, HOWEVER, THE PATIENT RETURNED TO THE HOSPITAL ON THE NEXT DAY POST DISCHARGE WITH ABDOMINAL PAIN. IT WAS STATED THAT THE PATIENT WAS ADMITTED AND TAKEN TO SURGERY FOR AN ISCHEMIC RIGHT COLON. PATIENT DIED APPROXIMATELY 1 WEEKS POST INDEX PROCEDURE. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS BOWEL ISCHEMIA. THE PHYSICIAN STATED THAT THROMBUS WENT INTO THE SMA CAUSING THE RIGHT COLON ISCHEMIA. THE PHYSICIAN STATED THAT WIRE MANIPULATION COULD HAVE LEAD TO MORE THROMBUS GOING INTO THE SMA. THE PHYSICIAN DOES NOT BELIEVE THAT THE DEVICE LEAD TO THE COMPLICATION DUE TO IT BEING THE RIGHT COLON NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT EXPIRED.

  Patient problems: Embolism/Embolus; Ischemia; Pain

  MAUDE report 11886274 ↗
• InjuryOct 15, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 66MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY NEARLY SIX YEARS LATER WITH A TYPE IA AND IB ENDOLEAK THAT HAD LED TO A RUPTURED ANEURYSM. AN EMERGENCY INTERVENTION PROCEDURE WAS CARRIED OUT THE FOLLOWING DAY AND AN AORTIC CUFF, BILATERAL RENAL SNORKELS, ENDOANCHORS AND BILATERAL LIMB EXTENSIONS WERE IMPLANTED. THE EVENT IS REPORTED TO BE RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 7964702 ↗
• DeathJun 28, 2018Difficult to Advance; Difficult to Advance

  AN ENDURANT II STENT GRAFT SYSTEM WAS PLANNED TO BE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE PHYSICIAN ATTEMPTED TO INTRODUCE THE BIFURCATED STENT GRAFT ETBF2313C124E THOUGHT THE LEFT EXTERNAL ILIAC BUT WAS UNSUCCESSFUL. IT WAS REPORTED THAT THE PHYSICIAN THEN PRE-DILATED THE LEFT EXTERNAL ILIAC WITH A NON MDT 8X40 PTA BALLOON AND IT WAS THOUGHT THAT AN ILIAC TEAR OCCURRED AT THIS POINT. THE PHYSICIAN WAS STILL UNABLE TO ADVANCE THE BIFURCATED STENT GRAFT DELIVERY SYSTEM THROUGH THE EXTERNAL ILIAC. THE PHYSICIAN REMOVED THE DELIVERY SYSTEM AND PLACED A 14F SHEATH TO ACHIEVE HAEMOSTASIS IN THE ARTERIOTOMY. THE PHYSICIAN THEN ATTEMPTED TO BALLOON THE LEFT EXTERNAL ILIAC WITH A 10MM PTA BALLOON. UPON REMOVING THE CONTRAST FROM THE PTA BALLOON, THE ANAESTHESIOLOGIST STATED THAT THE BLOOD PRESSURE WAS DROPPING. THE PHYSICIAN THEN ADVANCED THE 14F SHEATH INTO THE DISTAL AORTA AND THEN PLACED AN ENDURANT II ILIAC EXTENSION STENT GRAFT ETEW1010C82E INTO THE SHEATH. AFTER POSITIONING THE SHEATH DISTAL TO THE ILIAC TEAR, THE PHYSICIAN DEPLOYED THE STENT GRAFT. THE PHYSICIAN STATED THAT THE B

  Patient problems: Death; Perforation of Vessels

  MAUDE report 7645505 ↗
• InjuryFeb 8, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 48MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK WAS 18-17MM IN DIAMETER AND 45MM IN LENGTH. THE RIGHT ILIAC ARTERIES MEASURED 10-11MM IN DIAMETER AND THE LEFT ILIAC ARTERIES MEASURED 10-9-11MM IN DIAMETER. IT WAS REPORTED THAT THERE WAS LEFT LIMB OCCLUSION AND THE PATIENT HAD CLAUDICATION STARTING AT THE LEFT BUTTOCK. THE PHYSICIAN ELECTED TO PERFORM A FEMORAL TO FEMORAL BYPASS AND THE EVENT WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Claudication; Occlusion

  MAUDE report 6312658 ↗

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-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-0290-2022 · Oct 15, 2021 · Open, Classified
  Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
• 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