ENDURANT® ENLW1624C124ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994761880), received between Nov 1, 2017 and Mar 21, 2022 — classified as 5 injuries.

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

• InjuryMar 21, 2022Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 11 YEARS POST THE INDEX PROCEDURE FOLLOW UP CT DEMONSTRATED ANEURYSMAL DILATION DISTAL TO THE PRIOR ENDOGRAFT WITH A LOSS OF SEAL NOTED IN ENLW1624C124E. THE APPROX AAA DIAMETER WAS NOTED AS 35MM. NO ENDOLEAK WAS OBSERVED TO THE AAA. INTERVENTION WAS COMPLETED WHERE AN ENDURANT LIMB ETLW1610C199E WAS PLACED TO EXTEND WITH SEAL ACHIEVED BEYOND NEW THE ANEURYSM. AS PER PHYSICIAN, THE CAUSE OF THE ANEURYSM WAS ANATOMY RELATED, WHERE THE PATIENT DEVELOPED DILATION DISTAL TO THE PRIOR REPAIR AS A RESULT OF DISEASE PROGRESSION.  NO ADDITIONAL CLINICAL SEQUELAE WAS REPORTED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm

  MAUDE report 13839122 ↗
• InjuryDec 18, 2019Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 87MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 7 MONTHS POST INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH ACUTE ABDOMINAL PAIN AND HYPOTENSION, PATIENT BLOOD PRESSURE UPON ARRIVAL INTO OPERATING SUITE WAS 57/46, RESULTING FROM A LARGE DISTAL TYPE IB ENDOLEAK. A RIGHT RETROPERITONEAL HAEMORRHAGE WAS IDENTIFIED ON THE ANGIOGRAM. A RIGHT FEMORAL ARTERY EXPOSURE WAS COMPLETED AND A DISTAL 28 X 28 X 82 EXTENSION PIECE WAS PLACED TO COVER THE RUPTURED AREA. EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY WAS COMPLETED AFTER THE PATIENT BECAME NORMOTENSIVE. EXTENSION OF THE GRAFT WAS COMPLETED AND EXTENDED INTO THE RIGHT FEMORAL ARTERY. BALLOON ANGIOPLASTY AND ADJUNCTIVE STENTING WAS COMPLETED. FINAL ANGIOGRAM INDICATED SUCCESSFUL EXCLUSION OF THE LEAK. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO LOSING THE PATIENT TO FOLLOW UP. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Low Blood Pressure/ Hypotension; Pain; Rupture

  MAUDE report 9488349 ↗
• InjuryMay 21, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 7 YEARS POST IMPLANT WITH A LEFT ILIAC RUPTURE. IT WAS NOTED ON A CT THAT THE LEFT ILIAC LIMB HAD MIGRATED TO THE LEVEL OF THE AORTIC BIFURCATION AND THAT THE LEFT ILIAC HAD EXPANDED. AN INTERVENTION WAS CARRIED OUT; A BALLOON WAS PLACED INSIDE THE BODY OF THE ENDURANT BIFURCATE FROM THE RIGHT, TO OCCLUDE BLOOD FLOW. THE PHYSICIAN THEN COILED THE LEFT HYPOGASTRIC AND IMPLANTED 2 ENDURANT LIMBS FROM THE STENT GRAFT BIFURCATION TO THE EXTERNAL ILIAC. ONCE THE ADDITIONAL STENT GRAFT LIMBS WERE IN PLACE, THE RUPTURE WAS NOTED TO BE OCCLUDED AND THE EVENT WAS RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED, DUE TO THE EXPANSION OF THE LEFT ILIAC. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 8627818 ↗
• InjuryAug 7, 2018Leak/Splash; Adverse 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 50MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 7 YEARS POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A TYPE IA ENDOLEAK. THE PHYSICIAN CARRIED OUT TREATMENT WITH THE PLACEMENT OF ANOTHER MANUFACTURER STENT GRAFT PROXIMALLY AND ANOTHER MANUFACTURER CUFF TO SUCCESSFULLY TREAT THE TYPE IA ENDOLEAK. ALTHOUGH BOTH EXISTING LIMBS WERE PATENT, THE PHYSICIAN CHOOSE TO RE-LINE THEM AS BOTH HAD CIRCUMFERENTIAL THROMBUS BILATERALLY. PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Injury; Thrombus

  MAUDE report 7755901 ↗
• InjuryNov 1, 2017Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE TREATMENT OF A 57MM ABDOMINAL AORTIC ANEURYSM. HOWEVER, IT WAS REPORTED THAT DURING A CT EXAMINATION PERFORMED APPROXIMATELY 6 YEARS POST IMPLANT, IT WAS OBSERVED THAT A LIMB HAD LOSS SEAL RESULTING IN A TYPE IB ENDOLEAK. IT WAS REPORTED THAT THE ENDOLEAK WAS SUCCESSFULLY TREATED BY EXTENSION OF THE CONTRALATERAL LIMB DOWN TO THE HYPOGASTRIC ARTERY WITH A LARGER DIAMETER LIMB. IT WAS REPORTED THAT THE CAUSE OF THE EVENT, AS PER THE PHYSICIAN, CANNOT CONCLUSIVELY BE DETERMINED HOWEVER, DISEASE PROGRESSION MAY HAVE BEEN A CONTRIBUTOR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6992648 ↗

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-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-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-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