Endurant® II ETBF2316C166ERecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00613994991218), received between Jun 28, 2017 and Jul 27, 2022 — classified as 2 deaths, 5 injuries.

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

• InjuryJul 27, 2022Malposition of Device; Malposition of Device

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 70CM ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE. CT SHOWED A TYPE IB ENDOLEAK FROM THE LEFT COMMON ILIAC DUE TO EXPANSION OF THE NATIVE ILIAC ARTERY. THE RIGHT COMMON ILIAC ARTERY HAD ALSO EXPANDED BUT THERE WAS NO ENDOLEAK OBSERVED. THE PROXIMAL MAIN BODY GRAFT HAD NO TYPE IA ENDOLEAK OR LOSS OR SEAL, BUT WAS 7MM DISTAL TO THE RENAL ARTERIES. THE PHYSICIAN DETERMINED THAT THERE WAS NOT ENOUGH AREA BELOW THE LEFT ILIAC GRAFT TO FLARE A LIMB. THE PHYSICIAN THEN COILED THE LEFT HYPOGASTRIC ARTERY, AND EXTENDED INTO THE LEFT EXTERNAL ILIAC ARTERY WITH A ETLW1616C93E (B)(4). THERE WAS ABOUT 1CM OF DISTANCE FROM THE RIGHT LIMB OF THE GRAFT (NO TYPE 1B LEAK), SO THE PHYSICIAN PLACED A ETLW1620C93E (B)(4) TO MAINTAIN A SEAL IN THE RIGHT COMMON ILIAC. A ETCF2525C49E (B)(4) WAS THEN PLACED INSIDE THE MAIN BODY OF THE ENDURANT GRAFT AT THE LEVEL OF THE RENAL ARTERIES. THE PHYSICIAN THEN PLACED HELI-FX ENDOANCHORS AT THE TOP OF THE PLACED CUFF.  IVUS SHOWED THAT THE LEFT HYPOGASTRIC ARTERY WAS NOT YET THROMBOSED AND RECEIVING COLLATE

  Patient problems: Insufficient Information

  MAUDE report 15111990 ↗
• DeathJan 6, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED ON AN UNKNOWN DATE APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED AND A TYPE IA ENDOLEAK WAS IDENTIFIED. THE ANEURYSM SIZE WAS REPORTED TO BE 130MM. A TAVR PROCEDURE WAS SCHEDULED FOR (B)(6) 2021 WHERE THE AORTIC ENDOGRAFTS WERE PLANNED TO BE EXPLANTED HOWEVER ON THE (B)(6) 2021 THE PATIENTS ANEURYSM RUPTURED. INTERVENTION WAS COMPLETED WHERE 2 28MM ENDURANT CUFFS WERE IMPLANTED. THE FIRST CUFF WAS DEPLOYED AT THE LEVEL OF THE SMA COVERING BOTH RENALS. THE SECOND CUFF WAS DEPLOYED DISTAL TO THE FIRST CUFF. THE TYPE IA ENDOLEAK WAS NO LONGER PRESENT AND THE ANEURYSM WAS NOT FILLING ON THE FINAL RUN. IT WAS REPORTED BY THE PHYSICIAN THAT THE PATIENT EXPIRED. NO CAUSE OF THE DEATH WAS PROVIDED HOWEVER THE PHYSICIAN COMMENTED THAT THE PATIENT HAD OTHER COMORBIDITIES. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Insufficient Information; Rupture

  MAUDE report 13174533 ↗
• DeathMar 4, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 6 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY. A TYPE IV ENDOLEAK OR GRAFT TEAR WAS SUSPECTED. INTERVENTION WAS COMPLETED WITH A NON MDT STENT IMPLANTED TO RELINE THE ENDURANT STENT GRAFT. IT WAS REPORTED THE PATIENT HAD CONTINUING HYPOTENSION AFTER THE STENT WAS RELINED AND THE PHYSICIAN ELECTED TO CONVERT TO OPEN REPAIR HOWEVER IT WAS REPORTED THE PATIENT EXPIRED. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY RELATED. THE CAUSE OF DEATH IS UNDETERMINED.

  Patient problems: Death; Low Blood Pressure/ Hypotension

  MAUDE report 8386396 ↗
• InjuryJul 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HELI-FX ENDOANCHORING SYSTEM WAS USED AS AN ACCESSORY DEVICE DUE TO CONCERN FOR LATE FAILURE IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 56MM ABDOMINAL AORTIC ANEURYSM. AN ENDURANT II STENT GRAFT SYSTEM WAS ALSO IMPLANTED DURING THE PROCEDURE. NINE ENDOANCHORS WERE SUCCESSFULLY IMPLANTED FROM THE MAIN BODY OF THE ENDOGRAFT TO THE PROXIMAL NECK. IT WAS REPORTED POST THE INDEX PROCEDURE THE PATIENT DEVELOPED BILATERAL INCISIONAL PAIN WHICH WAS TREATED WITH MEDICATION. ECCHYMOSIS AROUND THE INCISION SITE WAS OBSERVED THE FOLLOWING DAY WHICH RESOLVED WITHOUT TREATMENT. ONE DAY POST THE INDEX PROCEDURE BLEEDING AND ANEMIA WERE REPORTED. THIS EVENT WAS TREATED WITH A BLOOD TRANSFUSION AND CONFIRMED AS RESOLVED. ON THE SAME DATE THE PATIENTS URINARY OUTPUT WAS DECREASED AND A UTI WAS DIAGNOSED THE FOLLOWING DAY. TREATMENT WITH MEDICATION AND IVF REPLACEMENT RESOLVED THIS EVENT. A PLEURAL EFFUSION WAS ALSO DIAGNOSED ON THIS DAY. IT IS REPORTED THAT THIS RESOLVED WITHOUT TREATMENT. THE ABOVE REPORTED EVENTS WERE DETERMINED TO BE RELATED TO THE INDEX PROCEDURE. APPROXIMATELY ONE YEAR LATER THE PATIENT DEVELOPED THROMBOCYTOPENIA AND CARE HAS SINCE TRANSFERRED TO ANOTHER GROUP. NO ADDIT

  Patient problems: Blood Loss; Hematoma; Injury; Pain; Pleural Effusion; Renal Failure; Urinary Tract Infection

  MAUDE report 7657918 ↗
• InjuryFeb 1, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 71 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT RETURNED FOR FOLLOW UP ON AN UNKNOWN DATE. THE MAIN BODY OF THE STENT GRAFT WAS EXPLANTED BECAUSE OF A SUSPECTED TYPE IV ENDOLEAK. IT WAS NOTED THAT BOTH LIMBS AND THE SUPRA RENAL STENT WERE LEFT IN PLACE. IT WAS NOTED THAT THE EXPLANTATION RESOLVED THE ENDOLEAK AND THAT THE PRODUCT WILL BE REPLACED IN THE FUTURE BY AN MDT PRODUCT. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7233617 ↗
• InjuryOct 12, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 92.8 CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT HAD RIGHT THIGH CRAMPING WHEN BIKE RIDING AND WALKING; AS WELL AS, RIGHT LEG WEAKNESS. IMAGING REVEALED THAT THERE WAS AN OCCLUSION IN THE RIGHT LIMB. THE PHYSICIAN INVESTIGATOR ASSESSED THE EVENT RELATIONSHIP TO BE UNCERTAIN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED BY THEIR PHYSICIAN.

  Patient problems: Claudication; Occlusion; Weakness

  MAUDE report 6943829 ↗
• InjuryJun 28, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT HAD A ROUTINE FOLLOW UP SCAN. THE PATIENT HAD BEEN FOLLOWED FOR A PERSISTENT TYPE II ENDOLEAK. ON THE MOST RECENT SCAN THE PHYSICIAN NOTICED A NEW ENDOLEAK THAT WAS THOUGHT TO BE A TYPE I OR III ENDOLEAK. AN AORTAGRAM WAS DONE. AFTER REVIEW OF THE FILMS IT WAS DECIDED THAT THERE WAS AN ENDOLEAK EITHER FROM THE PROXIMAL ATTACHMENT ZONE OR THE BIFURCATION OF THE STENT GRAFT. THERE WAS A NOTICEABLE ENDOLEAK BUT THE ORIGIN OF THE ENDOLEAK COULD NOT BE DETERMINED. THE PLAN WAS TO IMPLANT A CUFF OR AUI DEVICE. THERE WAS ABOUT 1CM FROM THE RENALS TO THE TOP OF THE ORIGINAL GRAFT. THE PHYSICIAN THEN DECIDED TO PLACE AN ENDURANT AORTIC CUFF FOLLOWED BY TWO ENDURANT ILIAC CUFFS LINING THE LIMBS OF THE PREVIOUS STENT GRAFTS. THE AORTIC CUFF WAS BALLOONED FOLLOWED BY KISSING BALLOONS IN THE ILIACS. ANOTHER AORTAGRAM WAS PERFORMED AND THE ENDOLEAK HAD BEEN SUCCESSFULLY RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE

  Patient problems: Injury

  MAUDE report 6675330 ↗

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-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-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