Endurant® II ETBF2513C124ERecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00613994991225), received between Feb 3, 2017 and Jun 30, 2023 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (6 reports).

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.

• InjuryJun 30, 2023Leak/Splash; Leak/Splash

  AN E DURANT BIFURCATE STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM AND DISSECTION. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL EMERGENTLY TO THE HOSPITAL WITH A RUPTURED ANEURYSM.  IT WAS STATED THAT THERE WAS A TYPE IB ENDOLEAK AND POTENTIAL HOLE IN THE STENT GRAFT. INTERVENTION WAS PERFORMED WHERE THE PROXIMAL PART OF THE ENDURANT WAS REMOVED VIA OPEN AAA REPAIR.  PER THE PHYSICIAN , THE CAUSE OF THE EVENT WAS ANATOMY. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 17238530 ↗
• InjuryFeb 8, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATED STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT RETURNED FOR A FOLLOW-UP CT APPROXIMATELY 3Y3M POST INDEX PROCEDURE WHERE A TYPE IA ENDOLEAK WAS OBSERVED. THE PHYSICIAN DECIDED TO IMPLANT A CUFF AND ENDOANCHORS IN ORDER TO TREAT THE ENDOLEAK. THE PHYSICIAN PLACED A 25X25X49 ENDURANT CUFF AT THE LEVEL OF THE LOWEST RENAL AND INTO THE EXISTING BIFURCATED GRAFT. THEN BALLOONED THAT CUFF USING A RELIANT BALLOON, AND PLACED 9 ENDOANCHORS AROUND THE PROXIMAL END OF THE CUFF AND EXISTING GRAFT. ANOTHER AORTAGRAM WAS PERFORMED AND THE ENDOLEAK HAD RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 13480792 ↗
• InjuryMay 6, 2020Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT RETURNED APPROXIMATELY SIX YEARS POST THE INDEX PROCEDURE COMPLAINING OF HIP PAIN. A CT WAS PERFORMED WHICH SHOWED THE ANEURYSM WAS NOW 80MM AND A TYPE IA ENDOLEAK IS SUSPECTED. IT WAS ALSO REPORTED THAT THE PATIENT WAS APPARENTLY SYMPTOMATIC WITH RIGHT HIP PAIN AT THE TIME OF THE INDEX PROCEDURE. INTERVENTION WAS PERFORMED AND THE ENDOLEAK WAS FIXED WITH THE IMPLANTATION OF A CUFF AND 4 ENDOANCHORS, A REVIEW OF THE ORIGINAL FILMS SHOWED THAT THE ORIGINAL PLACEMENT WAS 1 CM LOWER THAN THE RENALS AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY AND NOTED THE AORTIC NECK DIAMETER INCREASED IN SIZE TO CREATE A LEAK. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 10027711 ↗
• MalfunctionSep 10, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 54 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE ONE MONTH FOLLOW UP SCAN A TYPE IA ENDOLEAK WAS NOTED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS PATIENT ANATOMY RELATED, DUE TO THE DIAMETER OF AORTA WHERE THE SUPRA-RENAL STENT SITS AND STENT GRAFT ANGULATION IN THE AORTIC NECK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8979101 ↗
• InjurySep 4, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 4 YEARS LATER, THE PATIENT PRESENTED WITH A TYPE IB ENDOLEAK FROM THE RIGHT LIMB. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED FROM DISEASE PROGRESSION OF THE LILAC LIMB. IT WAS REPORTED THAT THE NEXT DAY, INTERVENTION WAS CARRIED OUT AND AN ADDITIONAL LIMB WAS IMPLANTED TO TREAT THE EVENT AND THE ISSUE WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7841948 ↗
• InjuryAug 3, 2018Leak/Splash; Patient-Device Incompatibility; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 66MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING A FOLLOW UP CT SCAN APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE A TYPE IA ENDOLEAK WAS DETECTED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Injury; No Consequences Or Impact To Patient

  MAUDE report 7746937 ↗
• InjuryFeb 3, 2017Occlusion Within Device; Malposition of Device; Occlusion Within Device; Malposition of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THE PROXIMAL AORTIC NECK IS 20 MM IN DIAMETER AND 30 MM IN LENGTH, THERE IS SOME CALCIFICATION IN THE ILIAC ARTERIES. IT WAS REPORTED THAT DURING THE PRIMARY PROCEDURE THE BIFURCATED IPSILATERAL LIMB OCCLUDED THE LEFT INTERNAL ILIAC ARTERY. THE PATIENT¿S LEFT ILIAC MEASURED 2 CM LONG. THE PHYSICIAN ATTEMPTED TO ACCORDION THE IPSILATERAL LIMB DURING THE INITIAL PROCEDURE. HOWEVER THE LEFT INTERNAL ILIAC ARTERY WAS INADVERTENTLY COVERED. THE PHYSICIAN ELECTED TO PERFORM AN EMBOLECTOMY, IMPLANTED A BALLOON EXPANDABLE 8X57 BARE METAL STENT, AND THE BLOOD FLOW WAS RESTORED. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT IS DUE TO PATIENT ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 6301686 ↗

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-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-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-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