Endurant® II ETLW1616C82E (UDI 00643169467576)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169467576), received between Feb 6, 2017 and Sep 18, 2024 — classified as 8 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2024Material Deformation; Material Deformation

  AN ENDURANT II LIMB WAS INTENDED TO BE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 112MM RUPTURED AAA. IT WAS REPORTED THAT THE DEVICE WAS KINKED OUT OF PACKAGE AND WAS NOT INTRODUCED INTO THE PATIENT. THE KINK WAS LOCATED AT THE BEGINNING OF THE GRAFT COVER. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20244205 ↗
• InjurySep 14, 2023Device Damaged by Another Device; Device Damaged by Another Device

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 76MM AAA. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE BIFURCATE (B)(6) WAS DELIVERED VIA THE RIGHT GROIN AND DEPLOYED UNTIL THE CONTRA-LATERAL GATE WAS OPENED. THE CONTRA-LATERAL GATE WAS CANNULATED VIA THE LEFT GROIN ACCESS AND A MARKER PIGTAIL WAS USED TO VERIFY. A HAND INJECTION VIA THE LEFT SHEATH WAS PERFORMED TO DETERMINE THE LIMB LENGTH NEEDED. (B)(6) WAS DELIVERED AND DEPLOYED AND THE DELIVERY SYSTEM WAS REMOVED. THE DEPLOYMENT OF (B)(6) WAS COMPLETED AND THE DELIVERY SYSTEM WAS REMOVED. A 16F DRY-SEAL SHEATH WAS USED TO BACK-FILL THE ACCESS SITE. A HAND INJECTION VIA THE RIGHT ACCESS SITE WAS PERFORMED AND A MARKER PIGTAIL WAS USED TO DETERMINE THE LIMB LENGTH NEEDED. (B)(6) WAS DELIVERED AND DEPLOYED VIA THE 16F SHEATH AND THE DELIVERY SYSTEM WAS REMOVED. BALLOONING OF THE ENDOGRAFTS WAS PERFORMED USING 2 RELIANT BALLOONS AND AN IVUS WAS PERFORMED WHICH DETERMINED THE NEED FOR COVERED BALLOON MOUNTED STENTS IN THE PROXIMAL ILIAC ARTERIES. NON-MDT STENT GRAFTS WERE DEPLOYED AND AN ANGIOGRAM WAS PERFORMED WHICH REVEALED A POSSIBLE TYPE III ENDOLEAK. THE PHYSICIAN ELECTED TO EXTEN

  Patient problems: Insufficient Information

  MAUDE report 17743276 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 4 MONTHS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH PAIN AND WEAKNESS IN THE LEFT LEG. CT INDICATED THAT THE LEFT LIMB HAS CLOTTED OFF. PER THE PHYSICIAN THE CAUSE OF THE OCCLUSION IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 15914015 ↗
• InjuryApr 1, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR AN UNKNOWN ENDOVASCULAR TREATMENT. APPROXIMATELY 38 MONTHS POST INDEX PROCEDURE, IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN. A CT SHOWED A TYPE IIIA ENDOLEAK BETWEEN 16X13X124 AND THE 16X16X82 LIMBS. AN ENDURANT 16X16X156 WAS PLACED INSIDE THE LIMBS TO COVER THE DISCONNECT AND EXCLUDE THE ANEURYSM SAC. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 11602399 ↗
• MalfunctionNov 4, 2020Leak/Splash; Leak/Splash

  AN ANEURX BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A >50MM ABDOMINAL AORTIC ANEURYSM. AN AORTIC CUFF AEXCH242440 WAS ALSO IMPLANTED. IT WAS REPORTED THAT ON THE DATE OF AN ANGIOGRAM 8 YEARS LATER , IT WAS NOTED THAT THE PATIENT HAD A TYPE IA ENDOLEAK. IT WAS REPORTED THE AORTIC CUFF AEXCH242440 HAD MIGRATED. INTERVENTION TOOK PLACE 6 DAYS LATER, AN ENDURANT CUFF ETCF2525C49E & ENDOANCHORS WERE IMPLANTED TO RESOLVE THE IA ENDOLEAK & MIGRATION. IT WAS NOTED DURING THIS INTERVENTION, A TYPE IIIB ENDOLEAK WAS OBSERVED IN THE ANEURX BIFURCATE MAIN BODY GRAFT.  THE PHYSICIAN REALIGNED AND IMPLANTED ENDURANT LIMBS AND EXTENDED THEM EQUALLY PROXIMALLY TO PREVENT THE LEAK.  AT THE END OF CASE THERE WAS STILL A TYPE III LEAK BUT THERE WAS SIGNIFICANTLY LESS LEAKAGE. AS PER THE PHYSICIAN THE CAUSE OF THE IA ENDOLEAK WAS ANATOMY AND NOTED THE AORTIC NECK WIDENED. NO CAUSE OF THE IIIB ENDOLEAK WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10783696 ↗
• InjuryMay 21, 2020Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A CT PERFORMED NEARLY TWO YEARS AFTER THE INDEX PROCEDURE, SHOWED A TYPE III ENDOLEAK. AS PER THE PHYSICIAN IT IS THOUGHT THAT THE LIMB ETLW1628C124E HAS SEPARATED FROM THE MAIN BODY STENT GRAFT. IT WAS THEN CONFIRMED THAT THE STENT GRAFT LIMBS ETLW1616C82E AND ETLW1628C124E HAD SEPARATED. A SECONDARY PROCEDURE WAS CARRIED OUT FIVE DAYS AFTER THE ENDOLEAK WAS NOTED ON CT, AND THE STENT GRAFT LIMBS ETLW1628C156E AND ETLW1616C82E WERE IMPLANTED AS TREATMENT. FOLLOW UP CT SHOWED THAT THE ENDOLEAK IS RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm; Injury

  MAUDE report 10078037 ↗
• MalfunctionDec 2, 2019Difficult or Delayed Positioning; Deformation Due to Compressive Stress; Difficult or Delayed Positioning; Deformation Due to Compressive Stress

  AN ANEURX STENT GRAFT SYSTEM WAS USED FOR THE ENDOVASCULAR TREATMENT OF AN AORTIC ABDOMINAL ANEURYSM. THE ANEURYSM HAS A CURRENT SIZE OF 120MM. IT WAS REPORTED DURING A FOLLOW UP CT 12 YEARS AND 7 MONTHS LATER, THAT A TYPE IB ENDOLEAK WAS IDENTIFIED AT THE DISTAL PART OF THE RIGHT ILIAC LIMB. A SECONDARY PROCEDURE WAS CARRIED OUT FOR THE TREATMENT OF THE ENDOLEAK. AN ANGIOGRAM PREFORMED AT THE BEGINNING OF THE PROCEDURE CONFIRMED THE PRESENCE OF THE ENDOLEAK IN A VERY TORTUOUS ILIAC ARTERY. THE PHYSICIAN TREATED THIS BY PLACING AN ENDURANT II LIMB EXTENDING FROM INSIDE THE ANEURX LIMB INTO THE EXTERNAL ILIAC COVERING THE RIGHT HYPOGASTRIC ARTERY. IT WAS REPORTED THAT WHILE ATTEMPTING TO PLACE THE ENDURANT II LIMB THE TORTUOSITY OF THEVESSEL CAUSED THE LIMB TO KINK IN THE DELIVERY SYSTEM. THE LIMB WOULD NOT ADVANCE INTO THE PREVIOUS GRAFT DUE TO THE KINK. AS WELL IT WAS REPORTED THAT THIS DEVICE WAS THEN REPLACED BY ANOTHER MDT ENDURANT II LIMB. A 14FR SHEATH WAS FIRST PUT INTO THE ILIAC REACHING UP IN TO PREVIOUS GRAFT AND THIS HELPED THE NEW LIMB NAVIGATE THE TORTUOUS VESSEL. IT WAS SUCCESSFULLY DELIVERED AND THEN BALLOONED. IT WAS REPORTED THAT ON FINAL ANGIOGRAM THAT THE ENDOLEA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9395033 ↗
• MalfunctionNov 29, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 85MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS NOTED TO HAVE GOOD EVAR ANATOMY WITH A LONG NECK AND MINOR CALCIFICATION. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE UPON COMPLETION ANGIOGRAM, A LARGE BLUSH OF CONTRAST WAS NOTED BELOW THE NECK. ON REPEAT ANGIOGRAM WITH THE CATHETER PULLED FURTHER INTO THE STENT GRAFT TO ELIMINATE THE POTENTIAL OF A TYPE IA ENDOLEAK, THE ENDOLEAK WAS NOTED AGAIN. THE NECK WAS REBALLOONED AND ON FURTHER IMAGING WITH CO2 AS CONTRAST TO PRESERVE KIDNEY FUNCTION, THE ENDOLEAK WAS STILL PRESENT AND PERI-GRAFT. AFTER IMPLANTATION OF A CUFF THE ENDOLEAK WAS STILL PRESENT AND AFTER FURTHER IMPLANTATION OF ADDITIONAL STENT GRAFTS TO RELINE THE LIMBS THE ENDOLEAK WAS MOSTLY RESOLVED BUT STILL PRESENT MINIMALLY. THE PROCEDURE WAS COMPLETED. THE PATIENT HAD A FOLLOW-UP ULTRASOUND TWO DAYS POST THE INDEX PROCEDURE WHICH SHOWED THAT THE ENDOLEAK WAS STILL PRESENT. THE CAUSE OF THE ENDOLEAK NOTED WAS NOT PROVIDED AS PER THE PHYSICIAN. THE TYPE OF ENDOLEAK COULD NOT BE CONCLUSIVELY DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9391300 ↗
• InjuryAug 21, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60 MM ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2016. IT WAS REPORTED THAT CT, APPROXIMATELY TWO YEARS AND EIGHT MONTHS POST THE INDEX PROCEDURE, SHOWED CONTINUED EXPANSION OF THE ANEURYSM WITH NO EVIDENCE OF AN ENDOLEAK. UPON REACHING 80MM THE PHYSICIAN DECIDED TO EXPOSE THE AORTA AND LOOK FOR A TYPE II ENDOLEAK OR ANY OTHER ISSUE. UPON OPENING THE ABDOMEN AND EXPOSING THE GRAFT THE PHYSICIAN NOTICED BLOOD SEEPING THROUGH THE GRAFT MATERIAL AT MULTIPLE AREAS AT THE FLOW DIVIDER AND BELOW AND THROUGHOUT THE ILIAC LIMBS BILATERALLY. IT WAS REPORTED THAT THE PHYSICIAN THOUGHT IT WAS A TYPE IV ENDOLEAK. IT WAS DECIDED TO FINISH THE EXPLORATION AT THIS POINT WITHOUT CARRYING OUT ANY INTERVENTION. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY THREE MONTHS LATER WITH PAIN AND THE PHYSICIAN DECIDED AT THIS POINT TO CARRY OUT AN INTERVENTION. THE BIFURCATE WAS RELINED WITH A NON-MDT AORTIC CUFF AND THE LIMBS WITH NON-MDT EXCLUDER LIMBS. IT WAS REPORTED THAT THE PATIENT RESPONDED FAVOURABLY AND IS STABLE AND DISCHARGED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS A TYPE IV E

  Patient problems: Pain

  MAUDE report 8914280 ↗
• InjuryAug 29, 2017Material Deformation; Material Deformation

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE RIGHT ILIAC ARTERY IS 10MM, 11, 16, 15, 19, 21, 23, 22, 21, 18, 14 FROM PROXIMAL TO DISTAL. THE LEFT ILIAC IS 11MM, 13, 14, 17, 20, 19, 18, 13 FROM PROXIMAL TO DISTAL. IT WAS REPORTED THAT RIGHT AFTER THE INDEX PROCEDURE THE PHYSICIAN STATED THAT THE FINAL ANGIO SHOWED NARROWING OF THE RIGHT PROXIMAL ILIAC AND THE PULSE FELT WEAKER. THE PHYSICIAN PLACED A 10X25 (EXPRESS) STENT FROM ANOTHER MANUFACTURER. THE PHYSICIAN STATED THE CAUSE OF THE EVENT WAS ANATOMY RELATED, (THE PROXIMAL COMMON MEASURED 10MM AND THE DISTAL COMMON MEASURED 23 MM SO THEY NEEDED A 28MM FLARED DEVICE). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6827042 ↗
• MalfunctionMar 14, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE DELIVERY SYSTEM WAS INSERTED INTO THE PATIENT AND POSITIONED AT THE INTENDED LOCATION. THE PROXIMAL END OF THE STENT GRAFT STARTED TO DEPLOY WITHOUT ROTATING THE EXTERNAL SLIDER TO RETRACT THE GRAFT COVER. AS A RESULT, THE PHYSICIAN WAS UNABLE TO REPOSITION THE STENT GRAFT. THE STENT GRAFT WAS IMPLANTED TO THE INTENDED LOCATION DESPITE THAT IT DEPLOYED WITHOUT ROTATING THE EXTERNAL SLIDER, BECAUSE THE DELIVERY SYSTEM WAS ALREADY AT THE INTENDED LOCATION PRIOR TO DEPLOYMENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS. THE PHYSICIAN REMODELED THE STENT GRAFT WITH A BALLOON AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6403585 ↗
• InjuryMar 1, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.5 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS AORTIC NECK DIAMETER AT THE RENAL ARTERY WAS 25 MM, 20 MM DISTAL TO THE RENAL ARTERY THE AORTIC NECK IS 38 MM IN DIAMETER AND HAS 47 DEGREE ANGULATION. IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE THERE WAS A PROXIMAL TYPE I ENDOLEAK PRESENT. THE PHYSICIAN ELECTED TO IMPLANT TEN APTUS ENDOANCHORS AND THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED. ON THE SAME DAY, POST-OPERATIVE THE PATIENT EXPERIENCED RESPIRATORY INSUFFICIENCY RESULTING IN BRADYCARDIA AND ABDOMINAL PAIN. THE PATIENT WAS GIVEN MEDICATION AND REQUIRED PROLONGED HOSPITALIZATION. THE EVENT RESOLVED THREE DAYS POST IMPLANT. IT IS UNCERTAIN IF THE EVENT IS RELATED TO THE PROCEDURE OR THE DEVICE. APPROXIMATELY SIX WEEKS POST IMPLANT THE PATIENT PRESENTED AT A SCHEDULED FOLLOW UP VISIT WITH BILATERAL LEG PAIN AND SEVERE INCREASED VELOCITY IN THE LEFT ILIAC. AN ULTRASOUND WAS PERFORMED, REVEALING KINKING IN THE LEFT LIMB OF THE ENDURANT STENT GRAFT. LOWER EXTREMITY ARTERIAL INTERVENTION WAS PERFORMED. ANOTHER MANUFACTURER¿S 9X40 BARE METAL STENT WAS IMPLA

  Patient problems: Dyspnea; Occlusion; Pain

  MAUDE report 6370274 ↗
• InjuryFeb 6, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THERE WAS SEVERE CALCIFICATION IN THE FEMORAL ARTERIES. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH A COLD LEFT FOOT AND LEG PAIN WHILE WALKING. THE CT REVEALED THAT THERE WAS OCCLUSION OF THE LEFT INTERNAL, EXTERNAL ILIAC ARTERIES, AND BILATERAL ANTERIOR TIBIAL ARTERIES. THE PATIENT WAS HOSPITALIZED AND GIVEN AN IV WITH HEPARIN. THE PHYSICIAN ELECTED TO PERFORM A RIGHT FEMORAL TO LEFT FEMORAL BYPASS. THE BLOOD FLOW WAS RESTORED AND NO COMPLICATIONS. PER THE PHYSICIAN¿S DICTATION IN THE OPERATIVE REPORT THE SEVERE CALCIFICATION WAS MOST LIKELY THE CAUSE OF THE THROMBOSIS RESULTING IN THE OCCLUSION IN THE LEFT LIMB. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion; Pain

  MAUDE report 6305823 ↗

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