Endurant® II ETBF2516C124ERecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00613994991256), received between Jul 27, 2017 and Aug 10, 2022 — classified as 1 death, 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2022Material Deformation; Material Deformation

  AN ENDURANT IIS BIFURCATED STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM .  IT WAS REPORTED DURING THE INDEX PROCEDURE THE ENDURANT IIS WAS IMPLANTED WITH NO ISSUES. THE PHYSICIAN THEN ATTEMPTED TO IMPLANT A LIMB BUT INSTEAD BEGAN IMPLANTING A 25X16X124 ENDURANT II BIFURCATED STENT GRAFT AS THE WRONG DEVICE WAS OPENED BY THE REP. THE BIFURCATED GRAFT WAS PLACED IN THE GATE AS IF IT WERE THE CORRECT LIMB. TOO MUCH OF THE GRAFT HAD BEEN DEPLOYED TO RECAPTURE OR PULL IT OUT BEFORE THE PHYSICIAN NOTICED IT WAS THE WRONG GRAFT. THE PHYSICIAN DECIDED TO CONTINUE DEPLOYING THE BIFURCATED GRAFT INSIDE THE GATE OF THE ORIGINAL GRAFT(23X14X103). THE SUPRARENAL STRUTS WE¿RE ABOUT 7MM ABOUT THE LEVEL OF THE GRAFT BIFURCATION. THE GATE OPENED INSIDE THE COMMON ILIAC ARTERY. A 10X37 BARE METAL STENT WAS PLACED IN THE IPSILATERAL LIMB OF THE 25X16X124 GRAFT AT THE LEVEL OF THE CONTRA LATERAL GATE. THE GATE WAS CRUSHED AGAINST THE COMMON ILIAC WALL. THIS LEFT THE IPSILATERAL LIMB PATENT. THE OTHER LIMB OF THE ORIGINAL GRAFT WAS DEPLOYED WITH NO ISSUE. AFTER BALLOONING BOTH COMMON ILIAC LIMBS AN ANGIOGRAM WAS PERFORMED. BOTH LIMBS WERE PATENT AND NO ENDOLE

  Patient problems: Insufficient Information

  MAUDE report 15201537 ↗
• InjuryApr 25, 2022Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN 35 MM RCIAA .  IT WAS REPORTED THE PATIENT RETURNED FOR A FOLLOW-UP CT WHERE THE CT REVEALED THE CONTRA LATERAL LIMB (LEFT) WAS CRUSHED VISUALLY AND THE LIMB AND VASCULATURE TO THE LEFT COMMON FEMORAL ARTERY WAS THROMBOSED.  NO CAUSE AS PER THE PHYSICIAN WAS PROVIDED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 14192201 ↗
• InjuryDec 14, 2021Adverse 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 PROCEDURE. IT WAS REPORTED VIA TECHNICAL SERVICES APPROXIMATELY 21 MONTHS POST IMPLANT THAT THE PATIENT HAD CALLED TO INFORM THAT THE STENTS DIDN'T WORK AND WERE REMOVED. NO CAUSE OF THE EVENT WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 13001872 ↗
• InjuryOct 29, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY OVER SIX YEARS LATER WITH A RUPTURED ANEURYSM. THE PATIENT WAS BROUGHT TO THE OR WHERE IT WAS VERIFIED THAT THE GRAFT'S CONTRALATERAL LIMB HAD SEPARATED FROM THE MAIN BODY BIFURCATE. THE LEFT INTERNAL ILIAC ARTERY WAS COILED OFF AND THE CONTRALATERAL LIMB WAS REPAIRED WITH A 16X16X156 LIMB AND EXTENDED INTO THE LEFT EXTERNAL ARTERY WITH A 16X16X124 LIMB. THE IPSILATERAL RIGHT LIMB WAS ALSO FOUND TO HAVE A TYPE IIIA ENDOLEAK AT THE JUNCTION OF THE IPSILATERAL LIMB OF THE MAIN BODY AND THE EXISTING LIMB. A 16X28X124 LIMB WAS USED TO REPAIR THIS ENDOLEAK AND THE RUPTURE WAS CONTAINED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY & NATURAL CHANGES IN THE ANEURYSM SAC. THE PATIENTS LACK OF FOLLOW-UP WAS ALSO NOTED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 10755336 ↗
• DeathJul 24, 2020Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 35 MM AND 22 MM ABDOMINAL AORTIC ANEURYSM IN THE COMMON AND INTERNAL ILIAC ARTERY RESPECTIVELY. IT WAS REPORTED THAT DURING POST OPERATIVE CT, PATIENT WAS NOT ABLE TO MOVE THE LEGS, BUT HAD SENSATIONS AND PULSES. APPROXIMATELY 5 HOURS POST INDEX PROCEDURE, PATIENT HAD NO PULSES, SENSATION OR MOVEMENT IN THE LEGS. EVENT WAS TREATED WITH AN AX-BIFEMORAL BYPASS ON THE SAME DAY OF THE INDEX PROCEDURE. IT WAS REPORTED THAT THE PATIENT IS PARALYZED IN THE LEGS. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Death; Occlusion; Paralysis

  MAUDE report 10319490 ↗
• InjuryOct 11, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 56 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT CT FROM APPROXIMATELY TWO YEARS LATER SHOWED A TYPE IA ENDOLEAK. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 9178448 ↗
• MalfunctionJun 13, 2018Leak/Splash; Device Difficult to Setup or Prepare; Activation, Positioning or Separation Problem; Leak/Splash; Device Difficult to Setup or Prepare; Activation, Positioning or Separation Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 61 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING A ROUTINE FOLLOW UP CT SCAN PERFORMED APPROXIMATELY 3.5 YEARS POST INDEX PROCEDURE, IT WAS DISCOVERED THERE WAS A SEPARATION BETWEEN THE IPSILATERAL LIMB OF THE BIFURCATED DEVICE AND THE 16X24 LIMB IN THE RIGHT COMMON ILIAC. THE MAXIMUM ANEURYSMAL DIAMETER WAS 63MM. THIS SEPARATION CAUSED A TYPE 3 ENDOLEAK AND THE ANEURYSM TO GROW. IT WAS REPORTED THAT THIS SEPARATION WAS NOT EVIDENT IN PREVIOUS FOLLOW UP. AS PER THE PHYSICIAN, THEY HAD SOME DIFFICULTY WITH LIMB PLACEMENT DURING THE CASE (MOST DISTAL STENT RING DID NOT OPEN). THE PHYSICIAN STATED THAT THERE MAY NOT HAVE BEEN ADEQUATE OVERLAP AND THAT THE REMODELING OF THE AORTA CAUSED A SEPARATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm

  MAUDE report 7596038 ↗
• InjuryJul 27, 2017Leak/Splash; Leak/Splash

  HELI-FX APTUS ENDOANCHOR APPLIER WAS SELECTED FOR THE TREATMENT OF A PROXIMAL TYPE I ENDOLEAK OF ENDURANT STENT. IT WAS REPORTED THAT A DUPLEX ULTRASOUND REVEALED A PROXIMAL TYPE I ENDOLEAK OF THE ENDURANT STENT GRAFT. THE INVESTIGATOR IMPLANTED 6 HELI-FX APTUS ENDOANCHORS AND THE IMPLANTATION OF THE HELI-FX APTUS ENDOANCHORS WAS SUCCESSFUL. THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED. THE INVESTIGATOR DID NOT INDICATE THE CAUSE OF THE EVENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6749305 ↗

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 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