Endurant® II ETLW1620C124E (UDI 00613994991645)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00613994991645), received between Mar 30, 2017 and Sep 20, 2024 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (11 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2024Leak/Splash; Leak/Splash

  AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 76MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 16 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT IDENTIFIED A TYPE IB ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE TYPE IB ENDOLEAK WAS ANATOMY RELATED DUE TO DISEASE PROGRESSION IN THE RIGHT COMMON ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 20265358 ↗
• MalfunctionSep 7, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE TREATMENT OF A 70MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT CT IMAGES REVEALED A TYPE 1A AND 1B (LEFT) ENDOLEAK. THE PHYSICIAN STATED THAT IT APPEARS THAT THE NECK AND THE LEFT COMMON ILIAC HAVE DILATED TO A LARGER DIAMETER THAN THE DEVICE. IT WAS MENTIONED THAT THE PREVIOUS SCAN SHOWED THAT THE AAA WAS SHRINKING AND THERE WAS NO LEAK, HOWEVER THIS SCAN SHOWED AAA EXPANSION (NOW 62MM) AND 2 ENDOLEAKS. PER THE PHYSICIAN, THE CAUSE OF THE ENDOLEAK IS ANATOMY RELATED DUE TO NECK AND LEFT COMMON ILIAC ARTERY DILATATION. NO ADDITIONAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15368705 ↗
• InjuryMar 24, 2021Leak/Splash; Migration or Expulsion of Device; Material Deformation; Leak/Splash; Migration or Expulsion of Device; Material Deformation

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A >50MM AAA. APPROX 6 YEARS 5 MONTHS POST PROCEDURE, DURING A FOLLOW UP VISIT AN ENLARGING AAA WAS OBSERVED ALONG WITH A TYPE IIIA ENDOLEAK WHERE THE LIMBS OVERLAP ON THE LEFT CI. IT WAS REPORTED THE RIGHT LIMB HAD NEARLY PULLED OUT OF THE RIGHT ILIAC AND INTO THE SAC, THE LEFT LIMB HAD ALSO PULLED INTO THE SAC AND BOTH LIMBS WERE COMPRESSED DUE TO TORTUOSITY. THE LIMBS IMPLANTED INTO THE LCI WERE SEPARATED AND THE LIMB IN THE RCI WAS PULLED INTO THE SAC INTERVENTION WAS PERFORMED ON THE SAME DATE WHERE NON MDT STENTS WERE IMPLANTED BILATERALLY TO RESOLVE THE KINKING AND RELINED WITH NEW LIMBS AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11563013 ↗
• InjuryNov 23, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 63MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE PATIENT PRESENTED EMERGENTLY WITH LEG PAIN. KINKING OF THE STENT GRAFT WAS NOTED DISTAL TO THE FLOW DIVIDER. THE PATIENT RECEIVED MULTIPLE FASCIOTOMIES TO RELIEVE TENSION IN ADDITION TO TPA. PER THE PHYSICIAN, SHRINKING OF THE ANEURYSM (FROM 63MM TO 46MM) HAS CONTRIBUTED OVERALL TO CAUSING THIS EVENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury; Pain

  MAUDE report 8099473 ↗
• InjuryOct 2, 2018Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 73MM DIAMETER ABDOMINAL AORTIC ANEURYSM. ON 4 YEAR FOLLOW UP IT WAS REPORTED THAT A TYPE IB OR POTENTIALLY A TYPE II ENDOLEAK WAS OBSERVED DURING A FOLLOW UP CT. INTERVENTION WAS CARRIED OUT WITH COILING OF THE LEFT HYPOGASTRIC ARTERY AND EXTENSION OF THE LEFT ILIAC TO RESOLVE THE ENDOLEAKS. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO DISEASE PROGRESSION OF THE LEFT ILIAC. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7925082 ↗
• InjuryJul 27, 2018Migration or Expulsion of Device; Patient-Device Incompatibility

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING PATIENT FOLLOW UP APPROXIMATELY ONE YEAR AND 8 MONTHS LATER, A MIGRATED LIMB STENT GRAFT WAS IDENTIFIED. IT WAS REPORTED THE RIGHT ILIAC LIMB HAD PROXIMALLY MIGRATED OUT OF THE RIGHT COMMON ILIAC ARTERY. TWO DAYS LATER AN INTERVENTION PROCEDURE WAS PERFORMED AND AN ILIAC STENT GRAFT LIMB WAS INSERTED TO EXTEND THE MIGRATED LIMB BACK IN TO THE RIGHT COMMON ILIAC ARTERY. THE ISSUE WAS RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS CAUSED BY PATIENTS¿ ANATOMY DUE TO AGGRESSIVE AORTIC REMODELING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 7725508 ↗
• InjuryJun 7, 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 63MM ABDOMINAL AORTIC ANEURYSM. FOLLOWING A CT SCAN CARRIED OUT APPROXIMATELY 6 YEARS LATER IT WAS REPORTED THAT THE CONTRALATERAL LIMB IN THE LEFT COMMON ILIAC APPEARED TO HAVE MIGRATED PROXIMALLY INTO THE SAC OF THE ANEURYSM AND WAS NO LONGER IN THE LEFT COMMON ILIAC WHERE IT WAS ORIGINALLY IMPLANTED. THE PHYSICIAN REPORTED THE CAUSE OF THE EVENT TO BE ANATOMY RELATED. BECAUSE THE LENGTH OF THE LEFT COMMON ILIAC ARTERY WAS ONLY 22MM AND THE DIAMETER OF THE LEFT COMMON ILIAC ARTERY WAS ALREADY A DIAMETER OF 14-20MM THE PATIENT EXPERIENCED SOME DISEASE PROGRESSION OF THE LEFT COMMON ILIAC ARTERY WHEREBY THE LEFT COMMON ILIAC ARTERY DIAMETER WAS NOW 17-22MM AND THAT THE CONTRALATERAL LIMB LOST IT'S WALL APPOSITION. AN INTERVENTION PROCEDURE WAS CARRIED OUT A MONTH LATER. THE LEFT INTERNAL ILIAC ARTERY WAS EMBOLIZED AND AN ILIAC EXTENSION LIMB WAS IMPLANTED THAT OVERLAPPED WITH THE EXISTING CONTRALATERAL LIMB INTO THE LEFT EXTERNAL ILIAC ARTERY. THE EVENT WAS REPORTED TO BE RESOLVED FOLLOWING THE INTERVENTION PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7577068 ↗
• InjuryFeb 21, 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 A 56MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR FOLLOW UP CT THAT BOTH LIMBS HAD MIGRATED INTO THE ANEURYSMAL SAC LEADING TO BILATERAL TYPE IB ENDOLEAKS IN THE BIFURCATE AND LIMB. THE PHYSICIAN COMPLETED INTERVENTION WITH A 16X24X124 LIMB THAT WAS EXTENDED DOWN TO THE PROXIMAL HALF OF THE RCIA WITH GOOD SEAL NOTED. A SECOND 16X16X124 LIMB WAS THEN TELESCOPED THROUGH THAT AND SEALED IN THE DISTAL HALF OF THE RCIA. A 16X24X124 LIMB WAS IMPLANTED DOWN TO THE LEFT HYPOGASTRIC ARTERY WITH GOOD SEAL OBSERVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7285206 ↗
• InjuryDec 12, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM ON. IT WAS REPORTED THAT, APPROXIMATELY 2.5 YEARS POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN. A CT REVEALED THAT THERE WAS A DISTAL TYPE I ENDOLEAK THAT RESULTED IN A CONTAIN ABDOMINAL AORTIC ANEURYSM RUPTURE. THE NEXT DAY THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT ETEW2828C82E EXTENSION AND THE TYPE I ENDOLEAK WAS RESOLVED AND THE ANEURYSM WAS EXCLUDED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS RELATED TO THE PATIENT¿S ANATOMY; CONTINUED DISEASE PROGRESSION OF ILIAC ARTERIES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain; Rupture

  MAUDE report 7107404 ↗
• MalfunctionNov 10, 2017Leak/Splash; Leak/Splash

  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 THE PATIENT FOR FOLLOW UP CT, ON WHICH A TYPE IB ENDOLEAK ORIGINATING FROM THE LEFT COMMON ILIAC ARTERY WAS OBSERVED BY THE PHYSICIAN. THIS ENDOLEAK WAS CONFIRMED ON ANGIOGRAM. INTERVENTION WAS PERFORMED TO RESOLVE THE EVENT BY USING COILS TO EMBOLIZE THE LEFT HYPOGASTRIC ARTERY AND AN ENDURANT LIMB WAS USED TO BUILD ONTO THE LEFT EXTERNAL ILIAC. FINAL ANGIOGRAM SHOWED THAT THIS PROCEDURE RESOLVED THE TYPE IB ENDOLEAK ON THE LEFT SIDE BUT THERE WAS NOW OBSERVED A LEAK ON THE RIGHT SIDE. THE PHYSICIAN DECIDED TO STOP THE PROCEDURE AT THIS STAGE AND DISCUSS NEXT STEPS WITH THE PATIENT BECAUSE AS THEY DIDN'T WANT TO EMBOLIZE BOTH HYPO GASTRIC ARTERIES IN THE SAME SURGERY. THE TYPE IB ENDOLEAK REMAINS ON THE RIGHT SIDE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS ANATOMY RELATED DUE TO DISEASE PROGRESSION IN BOTH COMMON ILIAC ARTERIES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7016870 ↗
• InjuryAug 25, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A GREATER THAN 5.5 CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A TYPE IB ENDOLEAK FROM THE LEFT LIMB WAS OBSERVED AT A FOLLOW UP APPOINTMENT. AN INTERVENTION WAS PERFORMED AND A 16X13X93 EXTENSION WAS PLACED. THIS REPORTEDLY RESOLVED THE EVENT. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS VESSEL DILATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6819808 ↗
• InjuryAug 8, 2017Failure To Adhere Or Bond; Migration or Expulsion of Device; Failure To Adhere Or Bond; Migration or Expulsion of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT HAD EXTREMELY TORTUOUS ANATOMY. APPROXIMATELY THREE YEARS AND TEN MONTHS POST INDEX PROCEDURE A CT REVEALED THAT THERE WAS A DISTAL TYPE I ENDOLEAK ON THE RIGHT IPS LATERAL LIMB OF THE ENDURANT II STENT GRAFT BIFURCATE. ADDITIONALLY, IT WAS OBSERVED THAT THERE WAS AN INADEQUATE AMOUNT OF STENT GRAFT SEAL, BY THE LEFT CONTRALATERAL ENDURANT II LIMB, IN THE COMMON ILIAC ARTERY THAT WAS AT RISK OF DEVELOPING A DISTAL TYPE I ENDOLEAK. BOTH STENT GRAFT LIMBS WERE OBSERVED TO HAVE MIGRATED. THE PHYSICIAN ELECTED TO SCHEDULE THE PATIENT TO HAVE BILATERAL LIMB EXTENSIONS IMPLANTED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO UNDERSIZING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED BY THEIR PHYSICIAN.

  Patient problems: Injury

  MAUDE report 6773402 ↗
• InjuryMay 11, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ABDOMINAL PAIN. A RECENT CT REVEALED THAT THERE WAS A DISTAL TYPE I ENDOLEAK FROM THE LEFT COMMON ILIAC AND A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN IMPLANTED TWO PLUGS FROM ANOTHER MANUFACTURER IN LEFT HYPOGASTRIC ARTERY AND IMPLANTED AN ENDURANT STENT GRAFT FROM THE ORIGINAL ENDURANT STENT GRAFT DOWN INTO LEFT EXTERNAL ARTERY. THE DISTAL TYPE I ENDOLEAK WAS RESOLVED. THE PHYSICIAN ELECTED TO IMPLANT HELI-FX APTUS ENDOANCHORS IN THE PROXIMAL AORTIC NECK. THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENTS IS RELATED TO PATIENT ANATOMY DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 6562308 ↗
• InjuryMar 30, 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 AN AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN. A CT REVEALED THAT THE PREVIOUSLY IMPLANTED ENDURANT LIMB HAD RETRACTED UP INTO THE ANEURYSM AND THERE WAS NO LONGER ANY SEAL IN THE LEFT COMMON ILIAC ARTERY. THE PHYSICIAN RELINED THE ENTIRE LEFT SIDE OF THE GRAFT INTO THE LEFT EXTERNAL ILIAC ARTERY. THE FINAL ANGIOGRAM SHOWED THAT THE ENDOLEAK HAD BEEN SEALED OFF AND THE EVENT HAD RESOLVED. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Abdominal Pain

  MAUDE report 6447753 ↗

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