Endurant® II ETTF2525C70ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994991485), received between Apr 30, 2019 and Jul 29, 2021 — classified as 2 injuries.

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 16, 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.

• InjuryJul 29, 2021Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 71 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A CT WAS PERFORMED APPROXIMATELY 37 MONTHS LATER DUE TO ABDOMINAL PAIN, WHERE AN ENDOLEAK TYPE 1A WAS OBSERVED. IT WAS NOTED THAT THE AREA BELOW THE RENAL ARTERIES HAVE GROWN FROM 16MM TO 24MM WITHIN 3 YEARS. THE EVENT WAS TREATED WITH A 25X70 CUFF (V30450089) AND BOTH RENAL ARTERIES WERE SNORKELED WITH 6X59 NON-MEDTRONIC STENTS. 2 MEDTRONIC SHEATHS WERE ALSO USED. AS THE DISSECTION WAS NOT OBSERVED UNTIL THE END OF THE INTERVENTION IT COULD NOT BE DETERMINED IF THE DISSECTION WAS CAUSED BY THE MEDTRONIC SHEATHS OR THE NON-MEDTRONIC SHEATHS USED. IT WAS REPORTED THAT A DISSECTION WAS OBSERVED BY IVUS AS WELL AS ANGIOGRAPHY, EXTENDING FROM THE LEFT SUBCLAVIAN TO THE LEVEL OF THE CELIAC. THE PHYSICIAN BELIEVED THAT THE DISSECTION WAS PROBABLY CAUSED BY THE SHEATHS USED IN THE SNORKELS IN CONCERT WITH THE PATIENT'S POSSIBLE CONNECTIVE TISSUE DISORDER AS PER THE PHYSICIAN, CAUSE OF THE ENDOLEAK EVENT WAS THAT THE PATIENT MAY HAVE A DEGENERATIVE DISEASE. PER THE PHYSICIAN, SINCE THE DISSECTION STARTED AT THE SUBCLAVIAN, IT WAS PROBABLY

  Patient problems: Pulmonary Embolism; Vascular Dissection

  MAUDE report 12244694 ↗
• InjuryApr 30, 2019Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 43MM X 30MM PAU. THE PAU WAS LOCATED 6MM BELOW THE LOWEST RENAL ARTERY. THE PROCEDURE WAS COMPLETED UNDER SHORT NECK INDICATION. IT WAS NOTED THE PATIENT HAD VERY TORTUOUS ILIAC ARTERIES. THE PHYSICIAN OPTED TO IMPLANT A CUFF ONLY AS THE LEAST INVASIVE OPTION DUE TO PATIENT MEDICAL CONDITION. IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER AN ENDURANT CUFF (25/25/70) WAS IMPLANTED AN ANGIOGRAM PERFORMED IDENTIFIED FILLING OF THE ANEURYSM WITH CONTRAST WITH A TYPE IA ENDOLEAK. THE PHYSICIAN BALLOONED THE PROXIMAL NECK WITH A RELIANT BALLOON. ANOTHER ANGIOGRAM WAS COMPLETED AND ALTHOUGH THE FILLING OF THE ANEURYSM WAS LESS, IT STILL WAS NOT COMPLETELY RESOLVED. THE PHYSICIAN THEN PLACED 3 ENDOANCHORS. WHEN ATTEMPTING TO PLACE A 4TH ENDOANCHOR, IT PENETRATED THE WALL DURING THE FIRST PART OF DEPLOYMENT BUT UPON 2ND PART OF DEPLOYMENT THE ENDOANCHOR JUMPED UP AND BECAME FREE FLOATING IN THE AORTA. ATTEMPTS WERE MADE TO SNARE THE ENDOANCHOR WITHOUT SUCCESS. AS THE TYPE IA ENDOLEAK REMAINED THE PHYSICIAN THEN PLANNED TO IMPLANT AN ADDITIONAL CUFF COVERING THE ACCESSORY RENALS LANDING UNDER

  Patient problems: Injury

  MAUDE report 8565112 ↗

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-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-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 aort
• 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 i
• 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