Endurant® II ETTF2323C70ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994991478), received between Mar 9, 2018 and Feb 13, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Folded” (1 report).

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.

• InjuryFeb 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HELI-FX ENDOANCHORS WERE IMPLANTED PROPHYLACTICALLY IN AN ENDURANT STENT GRAFT SYSTEM DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED ONE DAY POST THE INDEX PROCEDURE THE PATIENT HAD A FEVER (102.6 F). MEDICATION WAS ADMINISTERED AND THE EVENT WAS RESOLVED. PER THE INVESTIGATOR THE CAUSE OF THE EVENT WAS POSSIBLY DEVICE AND PROCEDURE RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Fever

  MAUDE report 8334593 ↗
• MalfunctionMar 9, 2018Folded; Folded

  AN ENDURANT TUBE STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 30MM SACCULAR ABDOMINAL AORTIC ANEURYSM AND PENETRATING ATHEROSCLEROTIC ULCER. IT WAS REPORTED, DURING THE INDEX PROCEDURE, THAT THE PHYSICIAN DECIDED TO USE AN AORTIC EXTENSION GRAFT TUBE ONLY TO EXCLUDE THE ANEURYSM IN THE MID ABDOMINAL AORTA. THE GRAFT WAS INSERTED INTO THE PATIENT VIA THE RIGHT FEMORAL ARTERY USING A CUTDOWN APPROACH AND DEPLOYED AT THE LEVEL OF THE LOWEST ACCESSORY RENAL ARTERY. THE STENT GRAFT LANDED JUST ABOVE THE AORTIC BIFURCATION. IT WAS THEN REPORTED THAT THE PHYSICIAN RE-CAPTURED THE DELIVERY SYSTEM AND REMOVED IT FROM THE PATIENT. BALLOONING WAS PERFORMED USING A RELIANT BALLOON AND AN ANGIOGRAM WAS TAKEN WHERE NO LEAKS WERE NOTED, AND ALL VESSELS APPEARED TO BE INTACT, IT WAS OBSERVED HOWEVER, IT DID APPEAR LIKE THE GRAFT WAS NOT OPPOSING THE WALL ON THE RIGHT SIDE OF THE AORTA. FURTHER INVESTIGATION SHOWED THAT THE STENT GRAFT APPEARED TO BE PUSHING UP ON ITSELF ALONG THE POSTERIOR WALL. THE PHYSICIAN NOTED THAT THE DISTAL EDGE OF THE ANEURYSM WAS VERY CLOSE TO THE AREA WITH THE STENT GRAFT PUSHING UP ON ITSELF AND THE CT SHOWED HEAVY PLAQUE WHICH MIGHT HAVE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7327157 ↗

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