Endurant® II ETLW1628C146E (UDI 00763000389017)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000389017), received between Mar 28, 2025 and Mar 28, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 28, 2025Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE STENT GRAFT ETLW1628C146E ENDUR II LIMB HAD MIGRATED INTO THE ANEURYSM SAC AND A TYPE 1B LEAK WAS PRESENT. THE PATIENT WAS TREATED FOR AN ANEURYSM, AND THE 16X28X146 LIMB HAD LOST SEAL IN THE RIGHT COMMON ILIAC. CT SCANS WERE CONDUCTED TWICE. DUE TO THE LACK OF SEAL ZONE, TREATMENT INVOLVED USING A 16X10X199 LIMB, LANDING IN THE EXTERNAL, AND COILING OF THE INTERNAL. NO LEAK WAS VISIBLE ON THE POST-ANGIOGRAM. THE CAUSE WAS REPORTED AS ANATOMY WHICH WAS NOTED TO BE CONICAL. THE EVENT WAS RESOLVED BY COILING THE INTERNAL AND EXTENDING INTO THE EXTERNAL INTO A HEALTHIER VESSEL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21719890 ↗

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