Endurant® II ETTF2828C70ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994991492), received between Oct 4, 2018 and Oct 7, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 21, 2021Class IIOpen, Classified

   Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.

   Z-0657-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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.

• InjuryOct 7, 2020Leak/Splash; Leak/Splash

  AN ANEURX STENT GRAFT SYSTEM (BIFURCATE AND 4 LIMBS) WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. AN ENDURANT CUFF WAS IMPLANTED APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE IN THE THEN 120MM AAA FOR THE TREATMENT OF A TYPE IA ENDOLEAK. IT WAS REPORTED APPROXIMATELY 10 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT DEMONSTRATED A TYPE IIIA ENDOLEAK WHERE THE ENDURANT CUFF AND ANEURX MAIN BODY SEPARATED. INTERVENTION WAS COMPLETED WHERE A VALIANT NAVION STENT GRAFT WAS IMPLANTED AND THE ENDOLEAK CONFIRMED AS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE TYPE IIIA ENDOLEAK WAS DUE TO TORTUOUS ANATOMY AND ANGLED NECK. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 10641122 ↗
• MalfunctionOct 4, 2018Leak/Splash; Leak/Splash

  A HELI-FX ENDOANCHORING SYSTEM AND AN ENDURANT II STENT GRAFT CUFF WERE USED IN THE ENDOVASCULAR TREATMENT OF A TYPE IA ENDOLEAK OF THE PATIENT. THE PATIENT PREVIOUSLY HAD AN ANUERX STENT GRAFT SYSTEM IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY EIGHT AND A HALF YEARS PREVIOUSLY. IT WAS REPORTED THAT APPROXIMATELY A YEAR AND A HALF POST THE INTERVENTION PROCEDURE THAT PATIENT PRESENTED EMERGENTLY. A SLIGHT IN CREASE IN THE ANEURYSM WAS IDENTIFIED (76MM TO 84MM); WITH EVIDENCE OF A TYPE IA ENDOLEAK. THE PATIENT HAS DECIDED TO FORGO TREATMENT DUE TO OVERALL MEDICAL CONDITION MEASURE AND WAS DISCHARGED FROM HOSPITAL AND TRANSFERRED TO AN INPATIENT HOSPICE. THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7933155 ↗

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-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-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