ENDURANT® ENLW1616C82ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994761965), received between Sep 11, 2017 and Dec 6, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 16, 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.

• InjuryDec 6, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED BY THE PATIENT VIA TECHNICAL SERVICES THAT DURING IMPLANTATION OF ONE OF THE GRAFTS THERE WAS A KINK AND THE PATIENT LATER DEVELOPED CLAUDICATION. THE CLAUDICATION RESOLVED AFTER 1-2 YEARS WITH MEDICATION AND EXERCISE. IT WAS DETERMINED THAT COLLATERAL CIRCULATION DEVELOPED AND CLAUDICATION DIMINISHED. AFTER 4-5 YEARS DEVELOPED CLOGGING IN RIGHT FEMORAL ARTERY, AND DISTAL CREATING CLAUDICATION. NO CAUSE OF THE EVENT HAS BEEN PROVIDED.  NO ADDITIONAL CLINICAL SEQUELAE HAS BEEN PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 12932610 ↗
• InjurySep 11, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 8.0 CM ABDOMINAL AORTIC ANEURYSM. IT WAS NOTED THAT THERE WAS 30 DEGREES OF ANGULATION. IT WAS REPORTED THAT THE PATIENT PREVIOUSLY HAD ANOTHER MANUFACTURER¿S CUFF AND LIMB IMPLANTED FOR A TYPE IA AND IB, RESPECTIVELY. THE TYPE IB REPORTEDLY RESOLVED BUT THE TYPE IA REMAINED. THE PATIENT THEN PRESENTED EMERGENTLY WITH A MIGRATION AND TYPE IA ENDOLEAK. THE 18 HELI-FX ENDOANCHORS WERE IMPLANTED ALONG WITH A 32 ENDURANT AORTIC CUFF AND ANOTHER MANUFACTURER¿S STENT. A LEAK STILL REMAINED BUT IT COULD NOT BE DETERMINED IF IT WAS A TYPE IA OR A TYPE II. THE PHYSICIAN STATED THAT THE CAUSE OF THE MIGRATION AND TYPE IA WAS DUE TO DISEASE PROGRESSION; AND THE CAUSE OF THE TYPE IB WAS DUE TO UNDER-SIZING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED BY THEIR PHYSICIAN.

  Patient problems: Injury

  MAUDE report 6855441 ↗

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-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