Endurant® II ETLW1628C124E (UDI 00613994991348)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994991348), received between Mar 14, 2017 and May 8, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Leak/Splash” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 9 YEARS POST THE INDEX PROCEDURE, AN INTERVENTION PROCEDURE WAS COMPLETED DUE TO DISEASE PROGRESSION. THE INTERNAL ARTERY WAS COILED AND EXTENDED INTO THE EXTERNAL ILIAC ARTERY. PER THE PHYSICIAN THE REASON FOR INTERVENTION WAS DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 16884878 ↗
• InjuryJun 25, 2019Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED INTO THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTA ANEURYSM ON AN UNKNOWN DATE AT AN UNKNOWN LOCATION. VESSEL MORPHOLOGY AT THE TIME OF IMPLANT IS UNKNOWN. THE PATIENT ARRIVED VIA HELICOPTER TO TRAUMA CENTER. THE CT REVEALED THAT THE PATIENT HAD AN ENDURANT STENT GRAFT SYSTEM IMPLANTED WITH A TYPE III ENDOLEAK, SEPARATION BETWEEN THE CONTRALATERAL 16X28 ILIAC LIMB AND THE 28X28X82 EXTENSION ILIAC LIMB. THE PHYSICIAN IMPLANTED AN ENDURANT 16X18X124 ILIAC LIMB STENT GRAFT RE-LINING EXISTING STENT GRAFTS AT CONTRA GATE TO CONTRA LIMB OVERLAP. THE TYPE III ENDOLEAK, SEPARATION WAS RESOLVED. IT FURTHER WAS REPORTED THAT A CT SHOWED A TYPE III SEPARATION ENDOLEAK ON THE LEFT SIDE ON AN UNKNOWN DATE AND ANGIOGRAM CONFIRMED THE ENDOLEAK. THE ETLW1628C124E APPEARED TO HAVE SEPARATED FROM THE DISTAL EXTENSION. INTERVENTION WAS PERFORMED WITH THE ADDITION OF AN ENDURANT EXTENSION TO BRIDGE THE SEPARATION AND THE ENDOLEAK WAS NOT OBSERVED AGAIN. THE CAUSE OF THE EVENT IS RELATED TO ANATOMY AS PER THE PHYSICIAN DUE TO THE TORTUOSITY OF THE LEFT ILIAC. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8730900 ↗
• InjuryNov 13, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 1.5 YEARS POST INDEX PROCEDURE. A CT SCAN SHOWED A TYPE III SEPARATION, ENDOLEAK BETWEEN THE ENDURANT ILIAC LIMB AND THE ENDURANT ILIAC EXTENSION. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER ENDURANT ILIAC LIMB TO RECONNECT THE TWO DEVICES. THE TYPE III SEPARATION, ENDOLEAK WAS RESOLVED. 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 7023943 ↗
• InjurySep 22, 2017Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.7 CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A CT SCAN DISCOVERED THAT THE LEFT LIMB HAD PULLED UP TOWARD THE SAC AND A TYPE 1B ENDOLEAK HAD DEVELOPED. THE PHYSICIAN ELECTED TO EMBOLIZE THE INTERNAL ILIAC ARTERY AND EXTEND COVERAGE TO THE EXTERNAL ILIAC ARTERY BY IMPLANTING A 16MM X 13MM STENT GRAFT LIMB. THE PHYSICIAN DETERMINED THAT THE EVENT WAS RESOLVED AFTER THE INTERVENTION HAD BEEN PERFORMED. THE PHYSICIAN STATED THAT THE EVENT WAS ANATOMY RELATED; SPECIFICALLY, THE LEFT COMMON ILIAC HAD GROWN IN DIAMETER FROM ABOUT 24 MM TO ABOUT 30 MM. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6886520 ↗
• InjuryJun 22, 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 THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED ANEURYSM WITH A TYPE II ENDOLEAK FORM A LUMBAR ARTERY, TYPE IA ENDOLEAK DUE TO DISEASE PROGRESSION AND TYPE IB ENDOLEAK ON THE RIGHT LIMB. THE DECISION WAS MADE TO EXPLANT THE STENT GRAFT AND OPEN REPAIR. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS BECAUSE THE PATIENT WAS LOST TO FOLLOW-UP AND FROM THE TYPE II ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 6661178 ↗
• InjuryMar 14, 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 A CT REVEALED A RUPTURED LEFT COMMON ILIAC ARTERY. THE ILIAC LIMB MEASURE 33MM AND THE 28MM LIMB PLACED WAS NO LONGER APPOSED TO THE AORTIC WALL AND THERE WAS A DISTAL TYPE I ENDOLEAK PRESENT. THE LEFT HYPOGASTRIC ARTERY WAS EMBOLIZED AND A 16X10X156 LIMB WAS PLACED IN THE EXISTING 16X28X124 LIMB AND EXTENDED INTO THE LEFT COMMON ILIAC ARTERY. IT WAS NOTED THAT THE RIGHT LIMB (16X10X93) WAS PATENT AND HAD GOOD SEAL. THE EVENT WAS REPORTEDLY RESOLVED. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS DUE TO PATIENT ANATOMY; SPECIFICALLY, ANEURYSMAL DISEASE PROGRESSION OF THE LEFT HYPOGASTRIC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 6404692 ↗

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-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-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
• 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