ENDURANT® ENLW1613C124ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994761972), received between Jun 5, 2017 and Dec 22, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

6 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 60MM AAA. THE DIAMETER OF THE AORTA AT THE RENAL ARTERY WAS 28MM. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL APPROXIMATELY 14 YEARS AND 9 MONTHS LATER WITH PAIN AND ENDOLEAKS WERE IDENTIFIED. A TYPE IA ENDOLEAK WAS ASSOCIATED WITH THE ENBF2513C145E AND A TYPE IB WAS ASSOCIATED WITH THE ENLW1613C124E LIMB. INTERVENTION WAS PERFORMED ON THE SAME DATE AND AN ENDURANT CUFF AND ENDURANT II LIMB STENT GRAFT WERE IMPLANTED TO REPAIR THE ENDOLEAKS. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ATTRIBUTED TO DISEASE PROGRESSION OVER A 14 YEAR PERIOD. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 23861839 ↗
• MalfunctionFeb 9, 2024Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM AND ANEURX ILIAC LIMB WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN AAA. IT WAS REPORTED APPROXIMATELY 13 YEARS POST THE INDEX PROCEDURE, THE PATIENT RANG TECHNICAL SERVICES AND SAID THAT ONE OF THE STENT GRAFTS WAS LEAKING. THE PATIENT IS UNSURE WHICH GRAFT BUT KNOWS THAT IT WAS IMPLANTED IN 2011. THE PATIENT STATED THAT THE ANEURYSM HAS GROWN FROM 50MM TO 80MM ON A RECENT CT. THE PATIENT DID NOT REPORT ANY SYMPTOMS. NO CAUSE WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675634 ↗
• InjuryApr 16, 2019Adverse 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 THAT THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN APPROXIMATELY SEVEN YEARS LATER AND CT SHOWED A TYPE IB ENDOLEAK ON THE RIGHT. IT WAS NOTED THAT THE RIGHT COMMON ILIAC ARTERY HAD DILATED AND NOW MEASURED 30MM. THE ORIGINAL IMPLANT ON THIS SIDE HAD A 20MM DIAMETER. THE PHYSICIAN COILED THE RIGHT HYPOGASTRIC AND THEN IMPLANTED THREE LIMBS ON THE RIGHT SIDE. IT WAS NOTED THAT THE LEFT SIDE ILIAC DIAMETER HAD ENLARGED AND WAS NOW 20MM WITH A 13MM DIAMETER STENT GRAFT PREVIOUSLY IMPLANTED, SO ANOTHER EXTENSION WAS ALSO IMPLANTED HERE. THE FINAL ANGIOGRAM SHOWED RESOLUTION OF THE TYPE IB ENDOLEAK AND GOOD PERFUSION TO THE LEFT HYPOGASTRIC ARTERY. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO NATURAL HISTORY OF ANEURYSM DISEASE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Abdominal Pain; Aneurysm

  MAUDE report 8517502 ↗
• InjuryAug 30, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A FOLLOW UP CT SCAN SHOWED AN ENLARGING ANEURYSM SAC. THE PATIENT WAS BROUGHT TO THE OR FOR ENDOLEAK REPAIR. ANGIOGRAM OF THE RIGHT ENDOGRAFT LIMB DEMONSTRATED A TYPE III ENDOLEAK. THE ENDOLEAK WAS REPAIRED WITH A 16X16X135 LIMB FROM ANOTHER MANUFACTURE. FINAL ANGIOGRAM SHOWED THE ENDOLEAK HAS BEEN RESOLVED. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS ANATOMY RELATED. THE CT SHOWED A LARGE PIECE OF CALCIUM NEAR THE FABRIC HOLE. THE PHYSICIAN STATED THAT THE 6 YEARS OF RUBBING ON THE CALCIUM PROBABLY CAUSED THE FABRIC TEAR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6829746 ↗
• MalfunctionJun 5, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE CT REVEALED A DISTAL TYPE I ENDOLEAK FROM THE ENDURANT IPSILATERAL LIMB OF THE BIFURCATED STENT GRAFT. THE ANEURYSM IS CURRENTLY 4.8 CM IN DIAMETER. THE PATIENT¿S ILIAC ARTERY HAS DILATED TO 24MM-18.5 MM IN DIAMETER. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT ILIAC LIMB EXTENSION TO THE ORIGIN OF THE INTERNAL ARTERY. THE DISTAL TYPE I ENDOLEAK WAS RESOLVED. THERE IS A TYPE IV ENDOLEAK PRESENT IN THE IPSILATERAL EXTENSION HOWEVER THE PHYSICIAN STATED THAT THIS WAS DUE TO A LARGE DOSE OF ANTI-COAGULATE MEDICATION GIVEN AND SHORT PROCEDURE TIME. IT WAS ALSO NOTED THAT THE ENDURANT CONTRALATERAL LIMB WAS OCCLUDED. IT IS UNKNOWN WHEN THE OCCLUSION OCCURRED, SINCE THERE IS BLOOD FLOW THERE HAS NOT BEEN AND WILL NOT BE TREATMENT FOR THE OCCLUSION. PER THE PHYSICIAN, THE CAUSE OF THE DISTAL TYPE I ENDOLEAK WAS DUE TO USER ERROR. THE IPSILATERAL LIMB SHOULD HAVE BEEN EXTENDED DISTALLY AT THE INDEX PROCEDURE. THE CAUSE OF THE OCCLUSION IS RELATED TO THE PATIENT¿S ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATI

  Patient problems: Occlusion

  MAUDE report 6612909 ↗

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-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-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-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
• Z-1543-2017 · Feb 27, 2017 · Terminated
  Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E ETBF2513C166E ETBF2313C166E ETBF2316C166