ENDURANT® ENLW1620C124ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994761910), received between Sep 19, 2017 and Apr 1, 2022 — classified as 4 injuries, 1 malfunction.

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 18, 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.

• MalfunctionApr 1, 2022Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATED STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM .  IT WAS REPORTED THE THE PATIENT RETURNED FOR A FOLLOW-UP AND A CT SHOWED THE PRESENCE OF TYPE IA AND TYPE IB ENDOLEAKS.  IT WAS REPORTED THAT THE LIMB MODEL MODEL ENLW1620C124E, IMPLANTED DURING THE INDEX PROCEDURE ALSO CONTAINED AN ENDOLEAK TYPE IB, AS PER THE PHYSICIAN. AS PER THE PHYSICIAN, THE CAUSE OF THE TYPE IA AND IB ENDOLEAKS IS DUE TO CONTINUED DILATATION OF THE AORTIC NECK AND COMMON ILIAC ARTERIES. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13976638 ↗
• InjuryJul 2, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A PATIENT. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY NINE YEARS LATER WITH LEFT LEG SWELLING, NUMBNESS AND TINGLING. THE PHYSICIAN STATED THAT THERE WAS NO PULSE FELT ON THE LEFT FEMORAL ARTERY WHILE THERE WAS A STRONG PULSE ON THE RIGHT FEMORAL ARTERY. AN ANGIOGRAM WAS PERFORMED AND IT WAS NOTED THAT THE LEFT LIMB WAS COMPLETELY PULLED UP INTO THE AAA SAC AND A THROMBUS WAS ALSO NOTED IN THE BODY OF THE STENT GRAFT AND THE LEFT LIMB. IT WAS REPORTED THAT THE LEFT EXTERNAL ILIAC WAS ALSO OCCLUDED. INTERVENTION WAS PERFORMED ON THE SAME DATE. AN ATHERECTOMY WAS PERFORMED AND THE THROMBUS REMOVED. AN AORTIC CUFF WAS IMPLANTED TO RELINE THE MAIN BODY AND A LEFT LIMB EXTENSION WAS ALSO IMPLANTED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS MOST LIKELY DUE TO THE PATIENT HAVING TO CROUCH AND BEND FOR A PROLONGED PERIODS OF TIME DUE TO WORK CONDITIONS. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 10225608 ↗
• InjuryJan 8, 2020Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM ON THE (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY TO ER APPROXIMATELY EIGHT YEARS AND 7MONTHS POST THE INDEX PROCEDURE WITH SEVERE ABDOMINAL PAIN. A CT SCAN PREFORMED EARLY ON THE FOLLOWING CONFIRMED A TYPE IB ENDOLEAK ON THE LEFT SIDE. THE ANEURYSM WAS NOTED TO BE 83MM IN DIAMETER. INITIALLY THE PATIENT'S CONDITION WAS REPORTED AS STABLE BUT THEIR CONDITION DETERIORATED AND AN ANEURYSM RUPTURE WAS CONFIRMED. IT IS REPORTED THAT THE PATIENT RECEIVED TREATMENT AND THE PHYSICIAN IMPLANTED A ETLW1616C93E BRIDGE LIMB AND A ETLW1628C93E LIMB TO EXTEND DOWN TO THE LEFT INTERNAL ILIAC ARTERY (IT WAS NOTED THERE WAS 91MM OF UNCOVERED LCIA). THE PHYSICIAN ALSO IMPLANTED AN ETLW1624C93E LIMB THAT EXTENDED DOWN TO THE RIGHT INTERNAL ILIAC ARTERY (IT WAS NOTED THERE WAS 20MM OF UNCOVERED RCIA). IT WAS REPORTED THAT THE EVENT WAS RESOLVED AND SEAL ACHIEVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY. IT IS REPORTED THAT THE PATIENTS ANEURYSM SAC CONTINUED TO DILATE OVER NINE YEARS AND HAD LOST SEAL RESULTING IN THE TYPE IB ENDOLEAK ON THE LEFT SIDE. NO

  Patient problems: Abdominal Pain; Rupture

  MAUDE report 9563248 ↗
• InjurySep 6, 2018Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN DIAMETER ABDOMINAL AORTIC ANEURYSM. APPROX. 7 YEARS, 4 MONTHS POST INDEX PROCEDURE, IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN. A CT REVEALED A LARGE AAA WITH AN ENDOLEAK AND INTRA-ABDOMINAL BLOOD SUSPICIOUS FOR AN AORTIC RUPTURE. THE CT SHOWED THAT BOTH IMPLANTED LIMBS WERE ¿FLOATING¿ IN THE AAA SAC DUE TO TYPE IB ENDOLEAKS FROM DISEASE PROGRESSION. THE RIGHT LIMB ALONG WITH THE ENTIRE ILIAC ARTERY WAS OCCLUDED. IT WAS NOTED THAT THE NECK AREA APPEARED TO BE QUITE DILATED WITH A POSSIBLE TYPE IA ENDOLEAK AND IT LOOKED LIKE THE STENT GRAFT HAD SLIPPED DOWN 6MM BELOW THE RENALS. THE AORTIC NECK DIAMETER WAS 34MM AND THE AAA DIAMETER WAS 82MM. NECK LENGTH WAS 6MM WITH A PROXIMAL NECK ANGULATION OF 45 DEGREES. INTERVENTION WAS CARRIED OUT WITH THE IMPLANTATION OF AN ENDURANT AUI AND EXTENSION TO THE EXTERNAL ILIAC ARTERY WITH TWO FURTHER LIMBS. TOUCH UP WAS THEN PERFORMED USING A RELIANT BALLOON. FOUR ENDOANCHORS WERE IMPLANTED NEAR THE TOP OF THE AORTIC AUI IMPLANT TO ENHANCE SEAL AND FIXATION. ANGIOGRAM SHOWED GOOD PATENCY AND NO SIGN OF AN ENDOLEAK

  Patient problems: Abdominal Pain; Myocardial Infarction; Occlusion

  MAUDE report 7849690 ↗
• InjurySep 19, 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 RETURNED FOR FOLLOW UP. THE CT REVEALED THAT THERE WAS A LEFT DISTAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER ENDURANT 16X24X156 STENT GRAFT. PER THE PHYSICIAN, THE CAUSE OF THE DISTAL TYPE I ENDOLEAK WAS RELATED TO THE PATIENT¿S ANATOMY OF DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6875681 ↗

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 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