Endurant® II ETLW1613C146E (UDI 00763000519940)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000519940), received between Apr 14, 2023 and Mar 28, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE INVOLVING THE STENT GRAFT ETLW1613C146E ENDUR II LIMB, AFTER INSERTION OF THE DEVICE INTO THE PATIENT AND POSITIONING FOR DEPLOYMENT BARE BACK, THE PHYSICIAN NOTICED THAT THE PROXIMAL GREY HANDLE WAS DISLODGED FROM THE DELIVERY SYSTEM. THE PATIENT WAS BEING TREATED FOR AN ANEURYSM OVER 55MM. IT WAS STATED THAT IS UNKNOWN WHETHER THE PHYSICIAN BEGAN DEPLOYMENT IN THE CORRECT DIRECTION. THE DEVICE WAS REMOVED WITHOUT INCIDENT, AND A NEW DEVICE WAS SUCCESSFULLY DEPLOYED. THERE WAS NO HARM TO THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718311 ↗
• MalfunctionMar 25, 2025Device Damaged Prior to Receipt by User; Material Deformation; Device Damaged Prior to Receipt by User; Material Deformation

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR AORTIC REPAIR PROCEDURE USING A STENT GRAFT ETLW1613C146E ENDUR II LIMB, THE DEVICE STOPPED ADVANCING. THE DELIVERY SYSTEM WAS FOUND TO BE DAMAGED, CAUSING A KINK. THE PATIENT WAS BEING TREATED FOR AN ANEURYSM WITH A SIZE OF 58 MILLIMETERS. A BIFURCATED GRAFT WAS SUCCESSFULLY DEPLOYED THROUGH PERCUTANEOUS ACCESS VIA THE RIGHT COMMON FEMORAL ARTERY. THE GATE WAS CANNULATED, AND A STIFF WIRE WAS POSITIONED FOR LIMB DELIVERY. THE DEVICE WAS PREPPED IN THE STANDARD MANNER AND INITIALLY PLACED ON A .045 STEERANT WIRE, BUT IT STOPPED ADVANCING. IT WAS STATED THERE WAS NO DAMAGE NOTED TO THE DEVICE DURING PREP, BUT THE DEVICE WAS NOT FULLY INSPECTED AT THE TIME. AFTER REMOVAL AND AFTER BEING WIPED DOWN IT WAS REINTRODUCED BUT THE SAME ISSUE OCCURRED. A NEW GRAFT 1613124 WAS THEN OPENED, SUCCESSFULLY ADVANCED, AND DELIVERED. INVESTIGATION REVEALED THAT THE BOX CONTAINING THE GRAFT WAS DAMAGED, WHICH APPEARED TO HAVE CAUSED THE KINK IN THE DELIVERY SYSTEM. IT IS BELIEVED THAT THE BOX WAS DELIVERED ALREADY DAMAGED, BUT THE DAMAGE WAS ONLY NOTED AFTER THE PROCEDURE. NO HARM WAS CAUSED TO THE PATIENT, AND THE PROCEDURE WAS COMPLETED SAFELY. ANOTHER G

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21686040 ↗
• MalfunctionSep 22, 2023Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  AN ENDURANT II STENT GRAFT WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 58MM AAA . IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE DELIVERY SYSTEM COULD NOT BE ADVANCED INTO THE VESSEL FOLLOWING DOTTERING. IT WAS NOTED THAT THE GRAFT COVER WAS DAMAGED. ANOTHER STENT GRAFT LIMB WAS USED TO COMPLETE THE PROCEDURE. THE SALES REPRESENTATIVE ATTENDING THE CASE BELIEVED THE DAMAGE TO THE DELIVERY SYSTEM WAS DUE TO THE INSERTION DIFFICULTIES AND NOT DUE TO CALCIFICATION. THERE WAS NO DAMAGE OBSERVED TO THE PACKAGING. THE DEVICE WAS INSPECTED BEFORE USE AND NO DEFECTS WERE OBSERVED. PER THE PHYSICIAN THE CAUSE OF THE POSITIONING DIFFICULTIES AND DEFORMATION COULD NOT CONCLUSIVELY BE DETERMINED. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17797139 ↗
• MalfunctionApr 14, 2023Leak/Splash; Defective Component; Material Deformation; Positioning Problem; Leak/Splash; Defective Component; Material Deformation; Positioning Problem

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA. NEARLY FOUR AND A HALF YEARS LATER ON A CTA, A TYPE IB ENDOLEAK WAS SEEN COMING FROM ONE OF THE ILIAC LIMBS (B)(4). IT IS UNKNOWN WHICH STENT GRAFT HAS THE IB AS BOTH STENT GRAFTS ARE THE SAME SIZE. 15 DAYS LATER AN ENDURANT II LIMB ETLW1613C146E WAS INTENDED TO BE IMPLANTED AS PART OF THE ENDOVASCULAR TREATMENT OF THE IB ENDOLEAK. THE AAA MEASURED 55MM. IT WAS REPORTED THAT DURING THE PROCEDURE, THE RIGHT INTERNAL ILIAC ARTERY WAS COILED FIRST BEFORE ATTEMPTING TO DELIVER THE LIMB  . AFTER THREE ATTEMPTS TO DELIVER THE STENT GRAFT IT WAS DISCOVERED THAT THE TAPERED TIP WAS NOT FLUSH WITH THE REST OF THE DELIVERY SYSTEM AND WAS GETTING HUNG UP ON THE TIGHT ACCESS SITE. IT WAS CONFIRMED THERE WAS A GAP BETWEEN THE TAPERED TIP AND RADIOPAQUE RING THUS CAUSING THE DELIVERY SYSTEM TO NOT BE SMOOTH AND THE GAP WAS CATCHING ON THE ANATOMY NOT ALLOWING IT TO ADVANCE THROUGH THE VASCULATURE. THE DEVICE WAS NOT INSPECTED UNTIL AFTER THE THIRD ATTEMPT TO DELIVER THE LIMB AND THAT IS WHEN IT WAS DISCOVERED IT WAS NOT A SMOOTH TRANSITION BETWEEN THE TAPERED TIP AND RADIOPAQUE RING. THE USE OF THIS STENT GRAFT

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742769 ↗

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-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