ENDURANT® ENBF3216C166ERecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00613994762429), received between Jan 30, 2017 and Mar 30, 2026 — classified as 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (14 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Fracture; Leak/Splash; Migration or Expulsion of Device; Detachment of Device or Device Component

  AN ENBF3216C166E STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN AAA. IT WAS NOTED THAT THE PATIENT IS NOW BEING FOLLOWED UP BY A PHYSICIAN WHO WAS NOT THE INITIAL IMPLANTER. IT WAS REPORTED APPROXIMATELY 15 YEARS POST THE INDEX PROCEDURE, FOLLOW-UP CT SHOWED A IA ENDOLEAK WITH ANEURYSM SAC EXPANSION. REVIEW OF THE CT AGAIN 2 DAYS LATER DETERMINED THAT THE SUPRARENAL STENT HAD BECOME DETACHED FROM THE MAIN BODY AND THE MAIN BODY HAD MIGRATED AWAY FROM THE RENAL ARTERIES WITH A IA ENDOLEAK PRESENT. THE PHYSICIAN PLANS TO DISCUSS FURTHER TREATMENT OPTIONS. PER THE PHYSICIAN THE CAUSE OF THE DETACHED STENT AND TYPE IA ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm expansion

  MAUDE report 24711190 ↗
• InjuryMar 30, 2021Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 82MM DIAMETER AAA. IT WAS REPORTED THE PATIENT WAS TREATED FOR A TYPE 2 ENDOLEAK COILING IMA AND LUMBAR BRANCHES ON AN UNKNOWN DATE. IT WAS REPORTED DURING A ROUTINE FOLLOW UP APPROXIMATELY 114 MONTHS POST INDEX PROCEDURE, WHAT APPEARED TO BE A TYPE II ENDOLEAK WAS OBSERVED ON CT. INTERVENTION WAS PERFORMED WHERE THE RIGHT AND LEFT LIMBS WERE EXTENDED WITH AN ETLW1620C124E AN ANGIO WAS THEN TAKEN WHICH SHOWED NO APPARENT ENDOLEAK. THE CATHETER WAS THEN PULLED INTO THE MAIN BODY OF THE STENT GRAFT WHICH SEEMED TO SHOW A TYPE IIIB ENDOLEAK. AN AUI DEVICE WAS THEN IMPLANTED AND A TALENT OCCLUDER WAS USED TO OCCLUDE THE LEFT ILIAC AND THE PROCEDURE WAS COMPLETED. 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: Insufficient Information

  MAUDE report 11589227 ↗
• InjuryMar 30, 2021Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A CT WAS PERFORMED APPROX 9 YEARS 1 MONTH POST IMPLANT, WHERE AN ENDOLEAK TYPE 1A WAS OBSERVED. AN ENDURANT CUFF ETCF3232C49E AND AN ENDURANT LIMB ETLW1616C156E WERE IMPLANTED ON THE (B)(6) 2021, BUT THE EVENT WAS NOT RESOLVED. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS ANATOMY DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELA WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 11589028 ↗
• InjuryApr 10, 2019Leak/Splash; Leak/Splash

  AN ANEURX AND AN ENDURANT STENT GRAFT SYSTEM WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF UNKNOWN SIZE. IT WAS REPORTED THAT ON AN UNKNOWN DATE, APPROXIMATELY 7 YEARS 2 MONTHS POST IMPLANT, IT WAS NOTED THAT ONE ON THE LIMBS HAD DISCONNECTED FROM THE MAIN BODY, CAUSING A TYPE III SEPARATION ENDOLEAK. AN INTERVENTION WAS CARRIED OUT TO BRIDGE THE GAP BETWEEN THE MAIN BODY AND ILIAC LIMB, USING A NON-MEDTRONIC STENT GRAFT. THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Injury

  MAUDE report 8498807 ↗
• MalfunctionApr 6, 2018Leak/Splash; Leak/Splash

  A TALENT AND ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 70MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT CT EXAM WAS PERFORMED APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE WHERE IT WAS OBSERVED BY THE PHYSICIAN THAT EITHER A TEAR OR A SEPARATION BETWEEN THE STENT GRAFT HAD OCCURRED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO ANGULATED AORTA, IN ADDITION TO THE TIME SINCE IMPLANTATION AND THE OFF LABEL NATURE OF THIS CASE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7403416 ↗
• InjuryMar 13, 2018Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT 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 WITH BACK AND ABDOMINAL PAIN APPROXIMATELY 7 YEARS POST INDEX PROCEDURE AND CT EXAM SHOWED A TYPE IA ENDOLEAK WITH POSSIBLE GRAFT MIGRATION. IT WAS NOTED THAT THE PATIENT WAS TAKEN TO OPERATING ROOM AND A 36X36X49CM ENDURANT CUFF WAS PLACED TO THE LEVEL OF THE RIGHT RENAL ARTERY WITH INTENTIONAL COVERAGE OF THE LEFT RENAL ARTERY. THE LEFT RENAL ARTERY WAS COVERED IN ORDER TO ACHIEVE PROXIMAL SEAL AS THERE WAS INSUFFICIENT SEAL ZONE BELOW THE LEFT RENAL ARTERY. IT WAS NOTED THAT THE PROXIMAL SEAL WAS ACHIEVED BUT THE PATIENT SUBSEQUENTLY STOPPED PRODUCING URINE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS RELATED TO APPARENT AORTIC NECK DILATATION AND SUBSEQUENT TILTING OF THE STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: Injury

  MAUDE report 7334683 ↗
• InjuryDec 21, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF UNKNOWN SIZE. A HELI-FX APPLIER AND ENDOANCHORS WERE USED IN THE ENDOVASCULAR TREATMENT OF A TYPE IA ENDOLEAK IN THE PATIENT. IT WAS REPORTED THAT THE PATIENT RETURNED FOR FOLLOW UP EXAM AND A CT EXAM SHOWED A TYPE IA ENDOLEAK. IT WAS NOTED THAT NO MIGRATION OF THE STENT GRAFT WAS OBSERVED BUT THAT AORTIC NECK DILATATION HAD OCCURRED, AND THIS HAD EFFECTED THE PROXIMAL SEAL. DURING THE PROCEDURE AFTER SUCCESSFUL IMPLANTATION OF A 36MM ENDURANT AORTIC CUFF AND 5 ENDOANCHORS, IT WAS NOTED THAT ON ATTEMPTED LOADING OF THE 6TH ANCHOR, IT WOULD NOT LOAD. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO LOAD THE 6TH ENDOANCHOR INVOLVING PRESSING THE FORWARD AND REVERSE MECHANISM MULTIPLE TIMES, IT WAS NOTED THAT A BROKEN PIECE OF AN ENDOANCHOR EXITED THE HELI-FX APPLIER. IT WAS UNKNOWN WHEN THE FRACTURING OF THE ENDOANCHOR OCCURRED. IT WAS NOTED THAT THE EVENT WAS RESOLVED WITH NO FURTHER TREATMENT. AS PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK WAS DUE TO ANATOMICAL DILATATION OF THE AORTIC NECK TO 31.4MM. THE EXISTING 32MM BIFURCATION STENT GRAFT LACKED THE OVERSIZING TO

  Patient problems: Injury

  MAUDE report 7137276 ↗
• InjuryNov 29, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 67 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON FOLLOW UP CTA PERFORMED APPROXIMATELY 6 YEARS POST INDEX PROCEDURE, A TYPE IA ENDOLEAK WAS IDENTIFIED. THE PATIENT WAS NOTED TO BE ASYMPTOMATIC AND WAS SCHEDULED FOR ROUTINE SECONDARY REPAIR. DURING THIS ENDOVASCULAR PROCEDURE, COILS, ONYX, A CUFF AND HELI-FX ENDOANCHORS WERE USED TO RESOLVE THE ENDOLEAK. 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 7066187 ↗
• InjuryNov 2, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 61 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING A ROUTINE FOLLOW UP CT A TYPE IA ENDOLEAK WAS OBSERVED. THE PATIENT WAS PRESENTED FOR TREATMENT OF THE ENDOLEAK. AN ENDURANT II CUFF WAS IMPLANTED PROXIMAL TO THE ORIGINAL BIFURCATED STENT GRAFT BUT UPON TRYING TO REMOVE THE DELIVERY SYSTEM IN THE ANGLED NECK IT GOT CAUGHT ON THE SUPRA RENAL FIXATION. THIS RESULTED IN THE CUFF BEING PULLED TO THE SAME LEVEL AS THE ORIGINALLY PLACED BIFURCATED ENDURANT STENT GRAFT. A SECOND ENDURANT CUFF AND 6 APTUS ENDOANCHORS WERE THEN PLACED AND EXTRA CARE WAS TAKEN IN REMOVAL OF THE DELIVERY SYSTEM. THIS RESOLVED THE TYPE IA ENDOLEAK. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED, DUE TO ANGULATED NECK ANATOMY AND DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6995669 ↗
• InjurySep 29, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A PRE-OPERATIVELY RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR FOLLOW UP A DILATED NECK AND DISTAL SEAL ZONES WERE OBSERVED. IT WAS REPORTED THAT THERE WERE TYPE IB ENDOLEAKS IN BOTH ILIAC ARTERIES AND THAT THERE WAS A PROXIMAL TYPE I ENDOLEAK. THE ENDOLEAKS APPEAR TO BE RELATED TO THE DILATED PROXIMAL AND DISTAL ZONES. THE PHYSICIAN EXPLANTED THE STENT GRAFTS AND TREATED SURGICALLY. THE PATIENT'S CREATININE HAS GONE FROM 2.8 TO 1.6. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6903257 ↗
• InjuryAug 17, 2017Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS INSERTED IN A IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 58.65MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY IN THE EMERGENCY ROOM ON WITH ABDOMINAL/BACK PAIN. A RUPTURED INFRA-RENAL ANEURYSM WAS DISCOVERED VIA CT SCAN. THE PATIENT WAS TRANSFERRED DIRECTLY INTO SURGERY WHERE THE PHYSICIAN EXPLANTED THE ENDURANT STENT GRAFT. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO PERSISTENT TYPE II ENDOLEAK RESULTING IN PROXIMAL NECK DILATATION LEADING TO PROXIMAL GRAFT MIGRATION OF 5-10MM AND AN EVENTUAL TYPE 1A ENDOLEAK WHICH WAS NOTED AT THE TIME OF EXPLANT SURGERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain; Rupture

  MAUDE report 6799815 ↗
• InjuryAug 11, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT CT IMAGING DISCOVERED A TYPE IB ENDOLEAK FROM THE RIGHT LIMB. ANGIOGRAPHY CONFIRMED THAT THE RIGHT LIMB HAD A DISTAL TYPE IB ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT BILATERAL ILIAC LIMB EXTENSIONS AND THE LEAK WAS RESOLVED WITHOUT INCIDENT. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS DUE TO PATIENT ANATOMY; SPECIFICALLY, PROXIMAL VESSEL DILATION AND LOSS OF SEAL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED BY THEIR PHYSICIAN.

  Patient problems: Injury

  MAUDE report 6787438 ↗
• InjuryJun 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 53MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT PATIENT HAD URINARY RETENTION AND PULMONARY COMPLICATION. THE INVESTIGATOR ASSESSED THE EVENT AS RELATED TO THE PROCEDURE AND NOT RELATED TO THE DEVICE. A FOLEY CATHETER WAS LEFT IN PLACE FOR THE URINARY RETENTION EVENT AND THE PATIENT REQUIRED OXYGEN AND MEDICATION AT DISCHARGE FOR THE PULMONARY COMPLICATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pulmonary Insufficiency; Urinary Retention

  MAUDE report 6623782 ↗
• InjuryApr 7, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.8 CM ABDOMINAL AORTIC ANEURYSM. DIAMETER OF THE NECK BELOW THE LOWEST RENAL ARTERY WAS 29MM AND THE LENGTH OF THE NECK WAS 49MM. IT WAS REPORTED THAT A TYPE IA ENDOLEAK WAS SEEN, AND A CHIMNEY PROCEDURE WAS PERFORMED IN THE LEFT RENAL USING ANOTHER MANUFACTURER¿S STENT AND AN ENDURANT AORTIC CUFF. IMAGING SHOWED EVIDENCE OF A RESIDUAL PROXIMAL TYPE I ENDOLEAK AT THE RIGHT LATERAL ASPECT OF THE AORTIC CUFF AND THE PHYSICIAN ELECTED TO IMPLANT FOR HELI-FX ENDOANCHORS. THE FINAL ANGIOGRAM REVEALED A VERY LATE PROXIMAL TYPE I ENDOLEAK AND WAS DETERMINED BY THE PHYSICIAN TO BE UNREMARKABLE SINCE THE SUBJECT WAS FULLY HEPARINIZED. THE PROCEDURE WAS COMPLETED WITH THE PATIENT SCHEDULED FOR NORMAL FOLLOW UP. ON THE DAY FOLLOWING THE PROCEDURE TO IMPLANT THE ENDOANCHORS, THE PATIENT DEVELOPED ACUTE KIDNEY INJURY. HYDRATION WAS ADMINISTERED AND THE EVENT IS CONTINUING BUT THE PATIENT WAS DISCHARGED. THE PHYSICIAN INVESTIGATOR ASSESSED THIS TO BE RELATED TO THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED BY THE PHYSICIAN.

  Patient problems: Renal Failure

  MAUDE report 6474081 ↗
• InjuryJan 30, 2017Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT WAS LOST TO FOLLOW UP. THE PATIENT PRESENTED WITH ABDOMINAL PAIN. THE CT REVEALED THAT THERE ANEURYSM EXPANSION, CURRENTLY 7.6 CM IN DIAMETER, THE PROXIMAL EDGE OF THE BIFURCATED STENT GRAFT WAS 6 MM BELOW THE RENAL ARTERY HOWEVER THERE WAS A GOOD SEAL WITH NO ENDOLEAKS PROXIMALLY, AND BILATERAL DISTAL TYPE I ENDOLEAKS. THERE WAS DILATATION OF RIGHT ILIAC ARTERY AND A SHORT COMMON ILIAC ARTERY CAUSING LOSS OF SEAL RESULTING IN THE ENDURANT IPSILATERAL ILIAC LIMB PULLING BACK INTO ANEURYSM SAC. THE PHYSICIAN ELECTED TO IMPLANT TWO ENDURANT ILIAC STENT GRAFTS BILATERALLY AND THE BILATERAL DISTAL TYPE I ENDOLEAKS WERE RESOLVED. THE PHYSICIAN STATED THE CAUSES OF THE EVENTS WERE RELATED TO THE PATIENT¿S ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 6288181 ↗

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