Endurant® II ETLW1628C93E (UDI 00643169467415)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169467415), received between Jan 17, 2017 and Jun 25, 2025 — classified as 2 deaths, 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A FOLLOW-UP VISIT APPROXIMATELY 1 YEAR AND 5 MONTHS AFTER THE INDEX PROCEDURE , A TYPE IB ENDOLEAK WAS IDENTIFIED IN THE LEFT ILIAC STENT GRAFT STENT GRAFT ETLW1628C93E ENDUR II LIMB. THE PATIENT HAD INITIALLY BEEN TREATED FOR A 100MM ANEURYSM. TO ADDRESS THE ENDOLEAK, AN ILIAC LIMB EXTENSION WAS SUCCESSFULLY IMPLANTED, FULLY RESOLVING THE ISSUE. PER THE PHYSICIAN, THE ENDOLEAK WAS ATTRIBUTED TO ILIAC DISEASE PROGRESSION . NO PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22325962 ↗
• DeathOct 3, 2024Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  FOUR TALENT STENT GRAFTS WERE IMPLANTED DURING ENDOVASCULAR TREATMENT OF AN 95MM ABDOMINAL AORTIC ANEURYSM. AN ENDURANT II STENT GRAFT LIMB WAS IMPLANTED 12 YEARS AND 1 MONTH POST INDEX PROCEDURE. IT WAS REPORTED 3 YEARS, 9 MONTHS LATER THE PATIENT PRESENTED EMERGENTLY, A CT SCAN REVEALED A TYPE III ENDOLEAK, WHICH RESULTED IN A SUBSEQUENT ANEURYSM RUPTURE. EMERGENCY INTERVENTION WAS PREFORMED USING 3 ENDURANT STENT GRAFT LIMBS (1620124, 1616124 AND 162493) TO BRIDGE THE SEPARATION BETWEEN THE ORIGINAL ILIAC LIMB AND THE BIFURCATED DEVICE FOLLOWED BY AGGRESSIVE BALLOONING WITH A RELIANT BALLOON. AN ANGIOGRAM CONFIRMED THE RESOLUTION OF THE TYPE III ENDOLEAK. THE PATIENT CONTINUED TO RECEIVE TREATMENT AFTER FOR COMPLICATIONS RELATED TO THE ANEURYSM RUPTURE. PER THE PHYSICIAN THE CAUSE OF THE TYPE III ENDOLEAK AND SUBSEQUENT RUPTURE IN UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information; Rupture

  MAUDE report 20359111 ↗
• DeathAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN THE EMERGENT ENDOVASCULAR TREATMENT OF A RUPTURED AAA .  IT WAS REPORTED THAT DURING THE PROCEDURE, THE EVAR WAS SUCCESSFUL AND THE ANEURYSM SEALED. THE PATIENT SUBSEQUENTLY EXPIRED.  PER THE PHYSICIAN THE CAUSE OF DEATH WAS THE RUPTURED ANEURYSM AND IT WAS SAID A MYOCARDIAL INFRACTION WAS POSSIBLE.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Myocardial Infarction

  MAUDE report 17496969 ↗
• InjuryJun 22, 2022Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 70MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 1 YEAR AND 4 MONTHS POST INDEX PROCEDURE, WITH A SYMPTOMATIC TYPE IB ENDOLEAK IN THE LIMB ETLW1628C93E. INTERVENTION WAS PERFORMED THE SAME DAY, THE PATIENT RECEIVED A LIMB EXTENSION AFTER EMBOLIZING THE INTERNAL ILIAC ARTERY AND BUILT DOWN INTO THE EXTERNAL ILIAC ARTERY. THIS RESOLVED THE ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY, AND DISEASE PROGRESSION CAUSED THE LIMB TO SUCK UP LEADING TO THE IB ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 14772521 ↗
• InjuryMar 23, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 68.5MM X 64 ABDOMINAL AORTIC ANEURYSM. AN ENDURANT CUFF AND LIMB WERE THEN IMPLANTED PRESUMABLY FOR THE TREATMENT OF A TYPE IA ENDOLEAK OVER 6 YEARS LATER. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY TO HOSPITAL NEARLY 3 MONTHS LATER, AFTER BEING FOUND UNCONSCIOUS ON THE FLOOR. A CT SHOWED A LARGE RUPTURED ABDOMINAL AORTIC ANEURYSM AND WHAT APPEARED TO BE A TYPE IA ENDOLEAK. THE PATIENT WAS TAKEN URGENTLY TO OR FOR CONVERSION TO OPEN REPAIR. IT WAS NOTED AT THIS TIME IN THE PATIENT¿S HISTORY THAT THE PATIENTS RIGHT KIDNEY WAS NOT FUNCTIONAL AS IT WAS TOTALLY ATRETIC AND THE LEFT RENAL ARTERY IS STENOTIC AND JAILED WITH 2 SUPRARENAL EXTENSIONS FROM THE ENDOGRAFT AND THE NEW PROXIMAL EXTENSION. ON THE RIGHT SIDE, THE INTERNAL ILIAC ARTERY IS COILED BECAUSE OF A COMMON ILIAC ANEURYSM AND THE STENT GRAFT EXTENDS INTO THE EXTERNAL ILIAC ARTERY. THERE WAS A VERY LARGE HEMATOMA ANTERIORLY AND IN THE RIGHT RETRO PERITONEUM . IT WAS SAID THE PATIENT PROBABLY HAD A STENT INSERTED INTO THE LEFT ANTERIOR DESCENDING ARTERY AROUND THE TIME OF THE EVAR. DURING THE OPEN CONVERSION

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Rupture

  MAUDE report 13856483 ↗
• InjurySep 20, 2021Leak/Splash; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A RENAL ARTERY ANEURYSM AND LEFT HYPOGASTRIC ARTERY ANEURYSM. PRIOR TO THIS THE PHYSICIAN HAD EMBOLIZED THE DISTAL HYPOGASTRIC BRANCHES AND PLACED A STENT COVERING THE ORIGIN OF THE LEFT HYPOGASTRIC ORIGIN. A FOLLOW-UP ANGIOGRAM SHOWED THE STENT COVERING THE ORIGIN WAS NOT COMPLETELY SEALING THE ORIGIN. SO THEN THE PHYSICIAN THEN DECIDED TO PLACE A FULL BIFURCATED STENT SYSTEM COVERING THE LEFT RENAL ARTERY ORIGIN AND ORIGIN OF THE LEFT HYPOGASTRIC. TWO DAYS POST THE INDEX PROCEDURE, THE PHYSICIAN REPORTED THAT THE PATIENTS LAB VALUES HAD CHANGED AND A FOLLOW-UP CTA SHOWED THE ANEURYSMAL ORIGIN OF THE RENAL ARTERY WAS STILL FILLING DUE TO THE INDEX STENT GRAFT BEING PLACED TOO LOW AND THE ORIGIN OF THE LEFT HYPOGASTRIC WAS STILL FILLING. A SECONDARY PROCEDURE WAS THEN PERFORMED WHERE THE PHYSICIAN PLACED COILS IN THE ORIGIN OF THE ANEURYSMAL RENAL ARTERY AND ALSO IMPLANTED AN ENDURANT AORTIC CUFF TO THE LEFT OF THE SMA AND PLACED ANOTHER ENDURANT AORTIC LIMB OVER THE ORIGIN OF THE LEFT HYPOGASTRIC ARTERY. IT WAS CONFIRMED THAT ENDURANT LIMB V30025760 WHICH WAS ORIGINALLY IMPLANTED FAILED TO

  Patient problems: Aneurysm; Insufficient Information

  MAUDE report 12497495 ↗
• InjuryAug 21, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 110 MM ABDOMINAL AORTIC ANEURYSM. HELI-FX ENDOANCHORS WERE ALSO IMPLANTED DURING THE PROCEDURE FOR PREVENTION OF NECK DILATION. IT WAS REPORTED THAT APPROXIMATELY THREE AND A HALF YEARS LATER THE PATIENT PRESENTED EMERGENTLY WITH BILATERAL LOWER ABDOMINAL PAIN AND A CTA SHOWED A TYPE IB ENDOLEAK OF THE RIGHT LIMB WITH ANEURYSM ENLARGEMENT. A SECONDARY INTERVENTION PROCEDURE WAS CARRIED OUT ON AND THE ENDOLEAK WAS REPAIRED WITH COIL EMBOLIZATION OF THE RIGHT HYPOGASTRIC ARTERY AND RIGHT STENT GRAFT LIMB EXTENSION WITH THE ENDURANT II STENT GRAFT LIMBS ETLW1616C156E, ETLW1616C124E AND ETLW1616C93E. INTERVENTION WAS SUCCESSFUL AND SUBJECT WAS DISCHARGED. THE EVENT WAS ASSESSED BY THE INVESTIGATOR TO BE POSSIBLY RELATED TO THE ENDOGRAFT. IT WAS ALSO REPORTED THAT THE PATIENT HAD PROCEDURAL BLEEDING THE DAY OF THE SECONDARY PROCEDURE. THE ESTIMATED BLOOD LOSS DURING THE REINTERVENTION PROCEDURE WAS 50CC BUT 1U OF PRBC WAS GIVEN IN THE OR TO PREVENT WORSENING OF CHRONIC ANEMIA AND THE EVENT WAS REPORTED TO BE RESOLVED. THE EVENT WAS ASSESSED BY THE INVESTIGATOR TO BE POSSIBLY RELATED TO THE R

  Patient problems: Blood Loss

  MAUDE report 8914228 ↗
• MalfunctionJul 30, 2018Leak/Splash; Detachment of Device or Device Component

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 64MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROX. 20 MONTHS POST INDEX PROCEDURE, THE PATIENT HAD A CT SCAN WHICH INDICATED A TYPE IB ENDOLEAK. IT WAS REPORTED THE LEFT COMMON ILIAC HAD DILATED TO 45MM AND THE DISTAL END OF THE LEFT STENT GRAFT LIMB WAS FLOATING IN THE LEFT COMMON ILIAC ARTERY. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO ANATOMY AND DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 7730568 ↗
• InjuryJun 27, 2018Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF UNKNOWN SIZE. IT WAS REPORTED THAT, APPROXIMATELY 2 YEARS POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. CT ON THIS DATE SHOWED LEFT ILIAC LIMB MIGRATION FROM THE LEFT ILIAC INTO THE ANEURYSMAL SAC WITH A TYPE IB ENDOLEAK. THE PATIENT RECEIVED TREATMENT; A NON MEDTRONIC LIMB WAS EXTENDED TO THE EXTERNAL ILIAC AND THE INTERNAL ILIAC WAS OCCLUDED WITH A COIL TO RESOLVE THE EVENT. PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 7641474 ↗
• InjuryFeb 14, 2018Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY. IT WAS NOTED THAT THE PATIENT HAD BEEN LOST TO FOLLOW UP AND HAD A TYPE IA ENDOLEAK AND A TYPE IB ENDOLEAK DUE TO DILATATION OF THE LEFT COMMON ILIAC ARTERY. IT WAS REPORTED THAT ON THE SAME DAY, A VALIANT STENT GRAFT AND HELI-FX ENDOANCHORS WERE USED TO OBTAIN SEAL PROXIMALLY AND A 16X13CM LIMB WAS USED TO EXTEND INTO THE EXTERNAL LIMB. THE EVENT HAS RESOLVED AND THE PATIENT IS STABLE. THE VALIANT STENT GRAFT WAS USED DUE TO A LACK OF OTHER DEVICES AND DUE TO THE SIGNIFICANT DISTANCE THAT WAS NEEDING TO BE COVERED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO DISEASE PROGRESSION OF THE ANEURYSM WITH EXTENSION ABOVE AND BELOW. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7269212 ↗
• InjuryJan 17, 2017Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE FOLLOW UP . THE CT REVEALED THAT THE ENDURANT 16X28X93 ILIAC LIMB MIGRATED PROXIMALLY WITH A DISTAL TYPE I ENDOLEAK. THE PHYSICIAN IMPLANTED AN ENDURANT ILIAC LIMB AND THE DISTAL TYPE I ENDOLEAK WAS RESOLVED. THE PHYSICIAN STATED THAT THE CAUSE OF THE STENT GRAFT MIGRATION AND DISTAL TYPE I ENDOLEAK WAS DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6258923 ↗

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-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-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 aortoili
• 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-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