Endurant® II ETLW1628C146E (UDI 00763000519988)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000519988), received between Jun 12, 2026 and Sep 28, 2026 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Leak/Splash; Migration or Expulsion of Device

  It was reported approximately 4 years post the index procedure, the patient presented emergently to an outside hospital with a ruptured aneurysm. Both implanted Endurant II limb stent grafts had reportedly pulled up into the aneurysm, and a Type Ib endoleak was identified. The patient was transferred to another healthcare facility and was treated using a non-Medtronic iliac branch device on the left side, embolization of the right internal iliac artery and extension of the right limb to the external artery. Per the physician, the aneurysm rupture was related to the Type Ib endoleak. The migration of the stent grafts into the aneurysm was attributed to disease progression. The reported event was resolved following treatment and no further patient complications were reported.

  Patient problems: Rupture

  MAUDE report 50912803 ↗
• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 56MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 2 MONTHS POST THE INDEX PROCEDURE FOLLOW UP CT SHOWED LEFT ILIAC HAD DISEASE PROGRESSION ASSOCIATED WITH ETLW1628C146E AND HAD ENLARGED. THERE WAS NO ENDOLEAK BUT THE PHYSICIAN ELECTED TO EXTEND INTO THE EXTERNAL ILIAC BEFORE ANY ISSUES OCCURRED. 2 ENDURANT LIMBS (16-16-124 & 16-13-124 ) WERE IMPLANTED AND EXTENDED INTO THE LEFT EXTERNAL ILIAC ARTERY RESOLVING THE ECTATIC LCIA. PER THE PHYSICIAN THE CAUSE WAS DUE TO DISEASE PROGRESSION SINCE ORIGINAL PROCEDURE WAS PERFORMED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm expansion

  MAUDE report 25484356 ↗

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