ENDURANT® ENLW1620C93ERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994761927), received between Sep 29, 2017 and Feb 6, 2024 — classified as 5 injuries, 1 malfunction.

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

• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 106MM AAA. IT WAS REPORTED THAT A CT WAS TAKEN APPROXIMATELY 13 YEARS POST THE INDEX PROCEDURE SHOWED A TYPE IA ENDOLEAK. IT WAS NOTED THAT THE PATIENT HAD A NON-MDT CUFF AND LIMBS PRESENT WITHIN THE ENDURANT GRAFT WHICH WERE IMPLANTED ON AN UNKNOWN DATE. THE ENDURANT STENT GRAFTS AND NON-MDT STENT GRAFTS WERE EXPLANTED. THE PATIENTS CONDITION IS POST THE EXPLANT PROCEDURE WAS NOTED AS ALIVE AND WELL. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK WAS ANATOMY RELATED AND DUE TO AORTIC NECK DEGENERATION. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 18650670 ↗
• MalfunctionSep 1, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF >50MM AAA. IT WAS REPORTED APPROX. 10 YEARS POST IMPLANT , CT IMAGES SHOWED THE LEFT LIMB PULLED COMPLETELY OUT OF THE LIMB AND LCIA HAD DILATED TO 53MM. THE RIGHT LIMB HAD ALSO PULLED INTO THE ANEURYSM SAC. IT WAS ADDITIONALLY REPORTED THAT PROXIMALLY, THE GRAFT IS IN A GOOD PLACE AT THE LEVEL OF THE LOWEST RENAL. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED PER THE PHYSICIAN NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12406082 ↗
• InjuryNov 23, 2018Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 63 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED WHEN THE PATIENT RETURNED FOR FOLLOW UP APPROXIMATELY SEVEN YEARS LATER A TYPE IB ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN COILED THE INTERNAL ILIAC ARTERY AND EXTENDED WITH AN ENDURANT LIMB ETLW1613C156E DURING AN INTERVENTION PROCEDURE. THE EVENT WAS REPORTED TO BE RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO PATIENT ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8099784 ↗
• InjurySep 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HELI-FX ENDOANCHORS WERE USED IN THE TREATMENT OF MIGRATION IN A PREVIOUSLY IMPLANTED ANEURX STENT GRAFT SYSTEM IN A PATIENT. ONE TALENT AORTIC CUFF WAS ALSO IMPLANTED TOGETHER WITH BILATERAL ENDURANT ILIAC CUFFS DURING THE PROCEDURE. THE AAA DIAMETER WAS NOTED AS 43MM. THE PROXIMAL AORTIC NECK MEASURERS 28MM WITH THE PROXIMAL AORTIC ANGLE OF 20 DEGREES. IT WAS REPORTED THAT ONE DAY POST INDEX PROCEDURE, THE PATIENT EXPERIENCED HYPOTENSION. MEDICATION WAS ADMINISTERED AND THE HYPOTENSION RESOLVED. PER THE INVESTIGATOR THE CAUSE OF THE EVENT WAS POSSIBLY RELATED TO THE INDEX PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury; Low Blood Pressure/ Hypotension

  MAUDE report 7897177 ↗
• InjuryOct 24, 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 ENDOVASCULAR TREATMENT OF A 6 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT WAS NOT COMPLAINT WITH FOLLOW UP APPOINTMENTS. A RECENT CT REVEALED THAT THERE WAS A THERE WAS GOOD PROXIMAL SEAL ALL THE WAY UP TO THE LOWEST RENAL ARTERY HOWEVER THERE IS A DISTAL TYPE IB ENDOLEAK ON THE RIGHT, IPSILATERAL SIDE AND THERE WAS LOSS OF STENT GRAFT SEAL ON THE LEFT, CONTRALATERAL SIDE. THERE WAS ALSO A3CM SACCULAR ANEURYSM NOTED AT THE DISTAL RIGHT COMMON ILIAC. PER THE INVESTIGATOR, THE DISTAL TYPE I ENDOLEAK AND THE LOSS OF SEAL ARE RELATED TO THE PATIENT¿S ANATOMY, DILATATION OF THE ILIAC LIMB. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THE PHYSICIAN. IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED TO FIX AT TYPE IB ENDOLEAK ON THE RIGHT LIMB. IT WAS NOTED THAT THE LEFT LIMB ONLY HAD 5 MM OF SEAL BEFORE IT COULD BE PULLED UP INTO THE ANEURYSMAL SAC ALSO. DURING THE PROCEDURE, A LEFT EXTENSION LIMB WAS IMPLANTED WITHOUT ISSUE. WHILE ATTEMPTING TO DEPLOY THE RIGHT EXTENSION LIMB, AN ISSUE OCCURRED WITH THE FULL DEPLOYMENT OF THE STENT GRAFT. THE PHYSICIAN WA

  Patient problems: Injury

  MAUDE report 6970965 ↗
• InjurySep 29, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A PRE-OPERATIVELY RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR FOLLOW UP A DILATED NECK AND DISTAL SEAL ZONES WERE OBSERVED. IT WAS REPORTED THAT THERE WERE TYPE IB ENDOLEAKS IN BOTH ILIAC ARTERIES AND THAT THERE WAS A PROXIMAL TYPE I ENDOLEAK. THE ENDOLEAKS APPEAR TO BE RELATED TO THE DILATED PROXIMAL AND DISTAL ZONES. THE PHYSICIAN EXPLANTED THE STENT GRAFTS AND TREATED SURGICALLY. THE PATIENT'S CREATININE HAS GONE FROM 2.8 TO 1.6. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6903268 ↗

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