Endurant® II ETBF2313C166ERecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00613994991188), received between Jun 12, 2017 and Apr 13, 2026 — classified as 10 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (11 reports).

1 FDA recall record name this device's identifier.

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 16, 2026.

Recalls naming this device

1. Feb 27, 2017Terminated

   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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Device Markings/Labelling Problem

  AN ENDURANT II STENT GRAFT ETBF2313C166E WAS INTENDED TO BE IMPLANTED. IT WAS REPORTED WHEN THE BOX WAS OPENED, THE OUTER PACKAGE WITH THE STICKERS/LABELS WAS MISSING. IT WAS NOTED THE SEAL WAS NOT BROKEN AND THE BOX HAD NOT BEEN OPENED BEFORE. IT WAS REPORTED WHEN THE BOX WAS OPENED BOTH CLEAR LABELS WERE STILL ATTACHED. WHEN IT WAS TAKEN OUT OF THE BOX, THE OUTSIDE LABEL PACKAGE WAS NOT ON IT AND IT WAS UNSURE IF DEVICE STERILITY WAS INTACT. THE DEVICE WAS NOT USED AND A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE CAUSE IS UNDETERMINED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24855419 ↗
• MalfunctionMar 28, 2025Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 60MM AAA. IT WAS REPORTED THAT DURING A FOLLOW-UP, BILATERAL TYPE IB ENDOLEAKS WERE NOTED. AN ILIAC LIMB WAS PLACED WITHIN (B)(6) TO CORRECT THE TYPE IB ENDOLEAK ON THE LEFT SIDE, WHILE NO INTERVENTION WAS PERFORMED ON THE RIGHT SIDE. THE TYPE IB OF THE LEFT ILIAC WAS TREATED AND RESOLVED. DISEASE PROGRESSION OF THE COMMON ILIAC ARTERIES BILATERALLY WAS NOTED AS THE CAUSE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718019 ↗
• MalfunctionFeb 28, 2023Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 60.6MM AAA ON THE. THE MAIN BODY WAS PLACED IPSILATERAL RIGHT AND EXTENDED WITH A 13X13X82 LIMB EXTENSION. A 16X16X156 ENDURANT WAS IMPLANTED AS THE CONTRALATERAL LIMB.  A CT WAS PERFORMED WHERE TYPE IA AND TYPE IB ENDOLEAKS WERE NOTED. THE NECK HAS DILATED TO GREATER THAN THE GRAFT SIZE PROXIMALLY AND BILATERALLY DISTALLY. AN ANGIOGRAPHY WAS ALSO PERFORMED. THE PATIENT IS ASYMPTOMATIC.  PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAKS IS NATURAL DISEASE PROGRESSION.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16451304 ↗
• MalfunctionMar 14, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 59.5MM ABDOMINAL AORTIC ANEURYSM. 4 ENDOANCHORS WERE IMPLANTED TO TREAT A TYPE IA ENDOLEAK DURING THE INDEX PROCEDURE. IT WAS REPORTED APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE, FOLLOW UP ULTRASOUND IDENTIFIED A TYPE IB ENDOLEAK. THE MAX DIAMETER OF THE AAA IS 57.7MM. NO RELATEDNESS ASSESSMENT HAS BEEN PROVIDED BY THE SITE OR THE SPONSOR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13758716 ↗
• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER THE STENT GRAFT WAS DEPLOYED A DISTAL AORTIC RUPTURE OCCURRED DURING ROUTINE BALLOONING. ENDOANCHORS WERE IMPLANTED PROPHYLACTICALLY FOR A TYPE IA ENDOLEAK. THE PROCEDURE WAS COMPLETED AND THE PATIENT TRANSFERRED TO ICU FOR MONITORING. THE PATIENTS CURRENT STATUS HAS BEEN DESCRIBED AS STABLE. PER THE PHYSICIAN THE CAUSE OF THE RUPTURE IS UNDETERMINED. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Rupture

  MAUDE report 10527329 ↗
• InjuryMar 11, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 71MM ABDOMINAL AORTIC ANEURYSM. IT WAS NOTED THAT DURING THE INDEX PROCEDURE A TYPE II ENDOLEAK WAS OBSERVED. IT WAS REPORTED THAT THE PATIENT RECEIVED A CT FOR AN UNRELATED CONDITION AND IT WAS OBSERVED THAT THE ANEURYSMAL SAC WAS ENLARGED TO 124MM. OPEN SURGERY WAS PERFORMED AND A SMALL HOLE WAS OBSERVED IN THE RIGHT POSTERIOR LATERAL ASPECT. THIS WAS CLOSED USING SUTURE AND THE REPAIR WAS REINFORCED USING BOVINE GRAFT MATERIAL AND THE ANEURYSM SAC THEN CLOSED OVER THE REPAIR. 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 8408175 ↗
• InjuryNov 29, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF UNKNOWN SIZE. THE NECK LENGTH WAS 16MM WITH DIAMETERS OF 19-20 MM. IT WAS REPORTED THAT AFTER IMPLANTATION, AFTER BALLOONING THE NECK AND LIMBS, A TYPE IA ENDOLEAK WAS NOTED ON THE COMPLETION ANGIOGRAM. THE NECK WAS RE-BALLOONED FOR A PROLONGED PERIOD AND ANOTHER ENDURANT STENT GRAFT WAS IMPLANTED ON THE SAME DAY. AFTER FURTHER TREATMENT THE LEAK WAS DIMINISHED ON THE ANGIOGRAM, BUT STILL PRESENT. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED, DUE TO A SHORT NECK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: Injury

  MAUDE report 8114565 ↗
• InjuryOct 1, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 3 YEARS 2 MONTHS LATER, A CT SCAN IDENTIFIED A TYPE IA ENDOLEAK. THE PHYSICIAN STATED THAT THE PATIENTS AAA INCREASED IN SIZE FROM 55MM TO 65-70MM. INTERVENTION WAS COMPLETED ONE MONTH LATER. THE PHYSICIAN HAD PLANNED TO INSERT AN AORTIC CUFF BUT ON FURTHER REVIEW IT APPEARED THERE WAS NO ROOM FOR A CUFF AND SO 5 ENDOANCHORS WERE IMPLANTED HOWEVER THE ENDOLEAK PERSISTED. THE PHYSICIAN THEN PROCEEDED TO PERFORM AN OFF LABEL CHEVAR TECHNIQUE TO EXTEND THE RENAL ORIFICE HIGHER AND IMPLANTED A LONGER 28X70 ENDURANT CUFF AND BILATERAL STENTS INTO THE RENAL ARTERIES WHILE SIMULTANEOUSLY BALLOONING ALL OF THE STENT GRAFTS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE ENDOLEAK RESOLVED. 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 7922818 ↗
• InjuryJan 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO ENDURANT STENT GRAFT AND HELI-FX ENDOANCHORS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN AORTIC ABDOMINAL ANEURYSM. CT EXAM SHOWED A MAXIMUM ANEURYSM DIAMETER OF 53MM. IT WAS REPORTED THAT 4 HELI-FX ENDOANCHORS WERE IMPLANTED IN THE PATIENT DUE TO CONCERN FOR LATE FAILURE. IT WAS NOTED THAT THE PATIENT HAD BACK PAIN AND IT WAS DEEMED TO BE CAUSALLY RELATED TO THE INDEX PROCEDURE BUT NOT RELATED TO THE DEVICE OR ANEURYSM. THE PATIENT RECOVERED WITH MEDICATION. IT WAS REPORTED THAT THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS SUICIDE AND NOT ANEURYSM RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Pain

  MAUDE report 7203374 ↗
• InjuryNov 20, 2017Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

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¿S ANATOMY; SEVERE ANTERIOR AORTIC NECK ANGLE, SEVERE LEFT ANGLE IN A VERY SHORT, CONICAL NECK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED BY THE PHYSICIAN.

  Patient problems: Injury

  MAUDE report 7044457 ↗
• MalfunctionOct 2, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, AT THE FINAL ANGIOGRAM, A TYPE IA ENDOLEAK WAS OBSERVED. THE PHYSICIAN DECIDED NOT TO TREAT THE ENDOLEAK AT THE TIME. PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6907770 ↗
• InjurySep 8, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. PROXIMAL NECK WAS 10MM AT IMPLANT WITH A 45 DEGREE ANGULATION. IT WAS REPORTED THAT A TYPE IA ENDOLEAK OCCURED. HELI-FX ENDOANCHORS WE IMPLANTED AND THE EVENT RESOLVED. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6851036 ↗
• InjuryAug 16, 2017Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS INSERTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 51 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. CURRENTLY THE RIGHT ILIAC IS 14.8 MM ¿ 10.3 MM FROM PROXIMAL TO DISTAL. THE LEFT ILIAC IS 15.5 MM, 13, 10.8 MM FROM PROXIMAL TO DISTAL. IT WAS REPORTED THAT A FOLLOW-UP CT WAS DONE AND SHOWED THAT THE ANEURYSM HAS GROWN FROM 5.1 CM TO 6.1 CM IN 18 MONTHS. NEITHER LIMB HAD WALL APPOSITION IN THE ILIAC ARTERIES, AND THE ILIACS HAD DILATED LARGER THAN THE 13 MM DIAMETER LIMBS. THERE WAS A 30-35 MM GAP FROM EDGE OF THE LIMBS TO THE HYPOGASTRIC ARTERY ON BOTH SIDES. THE PHYSICIAN ELECTED TO IMPLANT ENDURANT STENT GRAFT LIMBS BILATERALLY [16X13X93]. THE ENDOLEAK APPEARED TO BE RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED (THE LIMBS PULLED UP AS THE ANEURYSM SAC GREW AND THE ILIACS DILATED). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6796584 ↗
• InjuryAug 15, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT AFTER THE STENT GRAFT WAS IMPLANTED THERE WAS A TYPE IA ENDOLEAK. THE DECISION WAS MADE TO USE ENDOANCHORS. THE RADIOPAQUE MARKER ON GUIDE CAME OFF AFTER SECOND ENDOANCHOR DEPLOYMENT. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS DEVICE RELATED. PER THE PHYSICIAN, THE CAUSE OF THE ENDOLEAK WAS DUE TO THE PATIENT ANATOMY OF A SHORT CONICAL PROXIMAL AORTIC NECK. THE ENDOLEAK WAS FOUND TO HAVE RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6793664 ↗
• InjuryJun 12, 2017Microbial Contamination of Device; Microbial Contamination of Device

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DIRECTLY FROM THE PATIENT THAT THE PATIENT HAD PRESENTED WITH FLU LIKE SYMPTOMS, FEVER AND SHAKING. AFTER RECURRING RELAPSES AND PHYSICIAN APPOINTMENTS THE PATIENT WAS DIAGNOSED WITH ABDOMINAL INFECTION THAT IS BELIEVED TO BE ON THE ENDURANT STENT GRAFT BUT UNKNOWN CAUSE. PER THE PHYSICIAN, THE CAUSE OF THE INFECTION IS UNKNOWN. NO CLINICAL SEQUELAE WERE REPORTED AND THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT.

  Patient problems: Unspecified Infection

  MAUDE report 6635091 ↗

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 i
• 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 aort