Endurant® II ETLW1613C156E (UDI 00613994991553)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994991553), received between Feb 2, 2018 and May 16, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Leak/Splash” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING A FOLLOW UP CT, IT WAS FOUND THAT THE ANEURYSM SAC INCREASED TO 65MM. A TYPE II ENDOLEAK WAS IDENTIFIED AND A TYPE III ENDOLEAK WAS SUSPECTED. IT WAS NOTED THAT THE TYPE III DID NOT APPEAR TO BE A SEPARATION ENDOLEAK, BUT A POSSIBLE HOLE OR TEAR IN GRAFT . INTERVENTION WAS PERFORMED.  AN ANGIOGRAM WAS PERFORMED IN AP VIEW AFTER INFLATING A BALLOON IN THE CONTRA LIMB JUST BELOW THE FLOW DIVIDER. IT DEMONSTRATED LATE FILING OF THE AAA SAC, CONFIRMING THE TYPE II ENDOLEAK FROM THE PATENT LUMBAR ARTERY. HOWEVER, WHEN ROTATING THE IMAGE INTENSIFIER IN A MORE LATERAL PROJECTION, IT WAS FOUND A BLUSH OF CONTRAST FILLED BRISKLY INTO THE SAC 30-40MM DISTAL TO THE GATE IN THE 16X13X156 LIMB. THE ENDOLEAK WAS JUST DISTAL TO GATE AT THE FLOW DIVIDER AT THE TOP OF THE LIMB. IT WAS THEN DECIDED TO IMPLANT A ETLW1613C156E LIMB TO RELINE LANDING ABOVE THE HYPOGASTRIC ARTERY. THE PHYSICIAN OBTAINED ACCESS TO THE LUMBAR ARTERIES FROM THE LIIA USING A MICROCATHETER AND THEN NON MDT COILS WERE PLACED TO OCCLUDE THE ENDOLEAK. A FINAL ANGIOGRAM WAS TAKEN IN THE S

  Patient problems: Insufficient Information

  MAUDE report 14405483 ↗
• InjuryFeb 2, 2018Leak/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 EXAM WAS PERFORMED AFTER THE PATIENT PRESENTED TO ER WITH BACK PAIN. ON CT IT WAS OBSERVED THAT A TYPE III SEPARATION ENDOLEAK WAS PRESENT AND THERE WAS AN ANEURYSM RUPTURE. THE PATIENT WAS TAKEN TO THE OR AND 16/16/124 ENDURANT DEVICE WAS USED TO BRIDGE THE LIMBS TOGETHER. THIS TREATMENT RESOLVED THE EVENT. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain; Rupture

  MAUDE report 7237129 ↗

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-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