ENDURANT® ENBF3216C145ERecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00613994762436), received between May 2, 2017 and Feb 16, 2021 — classified as 11 injuries.

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.

• InjuryFeb 16, 2021Fracture; Leak/Splash; Fracture; Leak/Splash

  AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN. A CTA WAS PERFORMED WHICH SHOWED A TYPE IA ENDOLEAK AND A SUPRARENAL STENT FRACTURE. INTERVENTION WAS PERFORMED ON THE SAME DATE, AND AS THERE WAS NO ROOM TO IMPLANT A CUFF, THE PHYSICIAN ELECTED TO DO AN OPEN REPAIR AND EXPLANT THE STENT GRAFTS. THIS WAS PERFORMED SUCCESSFULLY. IT WAS STATED THAT THE CT FROM 2 YEARS POST THE INDEX PROCEDURE SHOWED NO STENT FRACTURE AND COMPLETE REMODELING OF THE ANEURYSM. THE PATIENT HAD BEEN FOLLOWED UP WITH ULTRASOUND SINCE THEN. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 11331380 ↗
• InjuryJul 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A PATIENT. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY NINE YEARS LATER, WITH LEFT LEG SWELLING, NUMBNESS AND TINGLING. THE PHYSICIAN STATED THAT THERE WAS NO PULSE FELT ON THE LEFT FEMORAL ARTERY WHILE THERE WAS A STRONG PULSE ON THE RIGHT FEMORAL ARTERY. AN ANGIOGRAM WAS PERFORMED AND IT WAS NOTED THAT THE LEFT LIMB WAS COMPLETELY PULLED UP INTO THE AAA SAC AND A THROMBUS WAS ALSO NOTED IN THE BODY OF THE STENT GRAFT AND THE LEFT LIMB. IT WAS REPORTED THAT THE LEFT EXTERNAL ILIAC WAS ALSO OCCLUDED. INTERVENTION WAS PERFORMED ON THE SAME DATE. AN ATHERECTOMY WAS PERFORMED AND THE THROMBUS REMOVED. AN AORTIC CUFF WAS IMPLANTED TO RELINE THE MAIN BODY AND A LEFT LIMB EXTENSION WAS ALSO IMPLANTED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS MOST LIKELY DUE TO THE PATIENT HAVING TO CROUCH AND BEND FOR A PROLONGED PERIODS OF TIME DUE TO WORK CONDITIONS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE

  Patient problems: Occlusion

  MAUDE report 10225627 ↗
• InjuryFeb 19, 2019Leak/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 ON AN UNKNOWN DATE, CT A TYPE IB ENDOLEAK WAS OBSERVED FROM THE RIGHT CIA WHICH HAD LOST SEAL AND HAS NOW INCREASED IN SIZE. APPROXIMATELY SEVEN YEARS POST THE INDEX PROCEDURE THE PHYSICIAN COILED THE RIGHT HYPOGASTRIC AND PLACED AN EXTENSION ENDURANT LIMB. ADDITIONALLY THE PHYSICIAN ELECTED TO IMPLANT AN AORTIC CUFF DUE TO CONCERN FOR A TYPE IA ENDOELAK. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO CONTINUOUS EXPANSION OF THE RIGHT CIA. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8349214 ↗
• InjuryFeb 21, 2018Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING A ROUTINE FOLLOW UP A TYPE IA ENDOLEAK WAS NOTED. THE PATIENT EXPERIENCED A PRE-OPERATIVE ANEURYSM RUPTURE WHICH THE PHYSICIAN CONFIRMED AS A CONTAINED RUPTURE. THE PATIENT RECEIVED TREATMENT WITH THE IMPLANTATION OF AN ENDURANT CUFF, PLACED TO THE SMA AND ANOTHER MANUFACTURES COVERED STENT INTO THE LEFT RENAL ARTERY CHANNELING DOWN THE AORTA OPENING JUST PASSED THE DISTAL END OF THE ENDURANT CUFF WITH FULL INFLOW TO THE LEFT RENAL ARTERY WITH RETROGRADE FLOW NOTED. THE TYPE IA ENDOLEAK DID NOT RESOLVE AFTER ENDURANT CUFF DEPLOYMENT AND BALLOONING. THE PHYSICIAN DEPLOYED 17 ENDOANCHORS. THE ENDOLEAK WAS NOT RESOLVED AND A SMALL TYPE IA ENDOLEAK WAS STILL VISIBLE AFTER ENDOANCHOR DEPLOYMENT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANEURYSM GROWTH. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Rupture

  MAUDE report 7285387 ↗
• InjuryJan 8, 2018Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON AN UNKNOWN DATE A TYPE IA ENDOLEAK WAS OBSERVED IN THE PATIENT. IT IS NOTED THAT THERE WAS NO MIGRATION OF THE STENT AND THAT THE AORTA HAD EXPANDED PAST THE NOMINAL DIAMETER OF THE DEVICE. ON AN UNKNOWN DATE, INTERVENTION WAS PERFORMED FOR THE TYPE IA ENDOLEAK BY THE IMPLANTATION OF A FENESTRATED CUFF TO SEAL THE ENDOLEAK. IT IS NOTED THAT THE EVENT HAS BEEN RESOLVED. 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 7172322 ↗
• InjuryJan 8, 2018Leak/Splash; Device Damaged by Another Device; Leak/Splash; Device Damaged by Another Device

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON AN UNKNOWN DATE A TYPE III ENDOLEAK WAS OBSERVED IN THE PATIENT. IT IS NOTED THAT THERE WAS NO MIGRATION OF THE STENT AND THAT THE AORTA HAD EXPANDED PAST THE NOMINAL DIAMETER OF THE DEVICE. IT WAS NOTED THAT IT WAS UNCLEAR IF THE TYPE III SEPARATION WAS A CONSEQUENCE OF A PREVIOUS INTERVENTION PREFORMED FOR A SEPARATE EVENT. ON AN UNKNOWN DATE, INTERVENTION WAS PERFORMED FOR THE TYPE III ENDOLEAK BY THE IMPLANTATION OF A LIMB COMPONENT TO BRIDGE THE GAP. IT IS NOTED THAT THE EVENT HAS BEEN RESOLVED. 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 7172225 ↗
• InjuryNov 14, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL APPROXIMATELY 6 YEARS AND 2 MONTHS POST INDEX PROCEDURE WITH ABDOMINAL PAIN. A CT SCAN SHOWED THAT THE ANEURYSM HAS GROWN FROM 5.5 CM TO 8.6CM A PROXIMAL TYPE I ENDOLEAK AND A DISTAL TYPE I ENDOLEAK WAS ALSO NOTED ON THE RIGHT. THE LEFT APPEARED TO HAVE A SEAL. THE PHYSICIAN IMPLANTED A 36X36X49 ENDURANT CUFF PROXIMALLY AND A 16X24X93 ENDURANT RIGHT SIDE EXTENSION DISTALLY. THE PROXIMAL ENDOLEAK HAS RESOLVED WITH THE CUFF PLACEMENT. THE RIGHT SIDE EXTENSION WAS PLACED WITH A SMALL RESIDUAL ENDOLEAK THAT WAS BALLOONED MULTIPLE TIMES. THE ENDOLEAK IMPROVED BUT THE DECISION WAS MADE TO HAVE A FOLLOW UP CT SCAN AFTER DISCHARGE. A RETROGRADE ANGIOGRAM WAS DONE ON THE LEFT SIDE AND NO ENDOLEAK WAS VISUALIZED. IT WAS REPORTED THAT THE PHYSICIAN CONFIRMED THAT, POST RE-INTERVENTION, THE PATIENT WAS NO LONGER HAVING ABDOMINAL PAIN OR TENDERNESS. PER THE PHYSICIAN THE EVENT WAS ANATOMY RELATED (DISEASE PROGRESSION). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT FINE.

  Patient problems: Pain

  MAUDE report 7028183 ↗
• InjurySep 29, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 82MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED TO AN OUTSIDE HOSPITAL WITH ABDOMINAL PAIN. THE CT SCAN REVEALED AN UNKNOWN ENDOLEAK WITH A CONTAINED RUPTURE. AN ANGIOGRAM WAS PERFORMED AND IT WAS DETERMINED THAT THE ENDOLEAK WAS MOST LIKELY COMING FROM A POSSIBLE HOLE IN THE BIFURCATION OF THE STENT GRAFT. PER THE PHYSICIAN, THE CAUSE OF THE EVENT/LOCATION COULD NOT CONCLUSIVELY BE DETERMINED WITHOUT THE STENT GRAFT BEING EXPLANTED. AN INTERVENTION WAS PERFORMED AND AN ENDURANT II AUI AND LIMB WERE IMPLANTED IN CONJUNCTION WITH A FEM-FEM BYPASS, RESOLVING THE EVENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain; Rupture

  MAUDE report 6903250 ↗
• InjuryJul 13, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS INSERTED IN A IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A ROUTINE FOLLOW-UP CT SHOWED THERE WAS A TYPE IA ENDOLEAK. THE PHYSICIAN IMPLANTED AN ENDURANT CUFF ONE DAY LATER AND THE ENDOLEAK WAS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED (DISEASE PROGRESSION OF THE PROXIMAL LANDING ZONE). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6712335 ↗
• InjuryJun 12, 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 THE PATIENT RETURNED FOR FOLLOW UP, AND THAT THERE WAS A PROXIMAL TYPE I ENDOLEAK IDENTIFIED. AN INTERVENTION WAS PERFORMED AND A 32X32X49 CUFF WAS PLACED. THIS REPORTEDLY RESOLVED THE ENDOLEAK. PER THE PHYSICIAN, THE CAUSE OF THE PROXIMAL TYPE I ENDOLEAK IS RELATED PATIENT ANATOMY OF AORTIC NECK DILATATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6635819 ↗
• InjuryMay 2, 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 THE PATIENT PRESENTED EMERGENTLY WITH BELLY AND BACK PAIN. A CT SHOWED THE PATIENT HAD A 3 VESSEL SNORKEL PROCEDURE; AND THAT THE NECK HAD CONTINUED TO DILATE CAUSING A TYPE IA ENDOLEAK TO DEVELOP BETWEEN THE SNORKELS. IT WAS NOTED THAT THE ANEURYSM MEASURED 8 CM IN DIAMETER TWO YEARS AGO BUT WAS 9.5 CM IN DIAMETER AT THE MOST RECENT SCAN. THE PATIENT WAS TAKEN TO THE OR AND ANOTHER MANUFACTURER¿S STENTS WERE PLACED IN THE RENAL ARTERIES AND THE SUPERIOR MESENTERIC ARTERY. A 36X36X100 VALIANT DEVICE WAS ALSO PLACE. AN ANGIOGRAM WAS PERFORMED AND THE ENDOLEAK REMAINED. 6 HELI-FX ENDOANCHORS WERE THEN PLACED, BUT THE ENDOLEAK WAS STILL PRESENT. THE PHYSICIAN WAS ABLE TO PLACE A WIRE BETWEEN THE SNORKELS AND INJECT THROMBIN INTO THE AREA OF THE ENDOLEAK. THIS REPORTEDLY RESOLVED THE EVENT. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS RELATED TO PATIENT ANATOMY; SPECIFICALLY, DISEASE PR OGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 6538909 ↗

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 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