Endurant® II ETLW1628C199E (UDI 00643169467439)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169467439), received between May 3, 2017 and Jun 21, 2024 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionJun 21, 2024Material Deformation; Material Deformation

  AN ENDURANT II STENT GRAFT LIMB WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN 28MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE SCRUB TECH PREPPED THE ENDURANT II LIMB. HOWEVER, IT WAS DISCOVERED THAT THE END OF THE DELIVERY SYSTEM WAS BROKEN, WITH THE END CRACKED AND BARELY HANGING ON. UPON ASSESSMENT, IT WAS CONCLUDED THAT THE DELIVERY SYSTEM WAS ALREADY DAMAGED BEFORE THE SCRUB TECH HANDLED IT. THE DEVICE WAS REPLACED, AND THE PATIENT RECEIVED TREATMENT. PER THE PHYSICIAN THE CAUSE OF THE DAMAGE WAS A BROKEN END OF THE DELIVERY SYSTEM HANDLE.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED, AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19582043 ↗
• DeathMay 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A COMMERCIALLY AVAILABLE ENDURANT II LIMB WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AS PART OF THE IMPLANT OF A NON-COMMERCIALLY AVAILABLE TVAAA DEVICE. IT WAS NOTED THAT THE DIAMETER OF THE AORTA AT THE DIAPHRAGM MEASURED 36MM AT THE TIME OF INTERVENTION. IT WAS REPORTED THAT THE PATIENT WAS INTUBATED FOR AN EXTENDED PERIOD OF TIME AS IT TOOK LONGER THAN EXPECTED FOR HIM TO WEAN OFF THE VENT. WHILE INTUBATED, AND AFTER EXTUBATION, THE SUBJECT HAD A STRONG COUGH. POST OPERATIVELY, THE PATIENT¿S BLOOD PRESSURE CONTINUED TO INCREASE WITH THE HIGHEST BLOOD PRESSURES MEASURED BEING 232/65 MMHG ON POST OP DAY 2 AND 212/99 MMHG ON POST OP DAY 3. THEY WERE TREATED WITH IV ANTIHYPERTENSIVE MEDICATIONS AS WELL AS HIS HOME REGIMEN OF ANTIHYPERTENSIVE MEDICATIONS TO DECREASE HIS BLOOD PRESSURE. DURING THE TIME OF INCREASED HYPERTENSION, THIS PATIENT HAD SEVERAL SIGNIFICANT COUGHING EVENTS. ON POST OP DAY 6, A CTA OF THE CHEST, ABDOMEN, AND PELVIS WERE COMPLETED AND A RETROGRADE TYPE B AORTIC DISSECTION WAS DISCOVERED IN THE DESCENDING THORACIC AORTA EXTENDING PROXIMALLY FROM THE VTAAA THORACIC BIFURCATION STENT GRAFT. THE PATIENT¿S BLOOD PRESSUR

  Patient problems: Death; High Blood Pressure/ Hypertension; Neurological Deficit/Dysfunction; Vascular Dissection; Weakness

  MAUDE report 6541471 ↗

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