Endurant® II ETBF3216C124ERecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00613994990976), received between Mar 29, 2017 and Jan 7, 2022 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 21, 2021Open, Classified

   Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.

   Z-0657-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2022Device Damaged Prior to Receipt by User; Material Deformation; Device Damaged Prior to Receipt by User; Material Deformation

  AN ENDURANT II BIFURCATED STENT GRAFT WAS INTENDED TO BE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 58MM ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED DURING THE INDEX PROCEDURE, DAMAGE WAS NOTED ON THE OUTER BOX AND ONCE THE BOX WAS OPENED IT WAS FOUND THAT THE BACK END OF THE DELIVERY SYSTEM WAS BROKEN. THE PHYSICIAN OPENED A NEW DEVICE IN ORDER TO PROCEED WITH THE PROCEDURE. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE THE DELIVERY SYSTEM BEING DAMAGED IN THE BOX. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13188845 ↗
• InjurySep 13, 2021Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF 65MM ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED THAT AN ENDOLEAK TYPE 1A WAS OBSERVED AT FINAL ANGIO  DURING THE INDEX PROCEDURE. AN ANGIOGRAM WAS CARRIED OUT ONE WEEK POST THE INDEX PROCEDURE WHEN IT WAS NOTED THAT THE ENDOLEAK TYPE IA WAS STILL PRESENT. IT WAS  STATED THAT AN INTERVENTION WAS CARRIED OUT ON THE SAME DATE AND A 32 AORTIC CUFF (B)(4)   WAS IMPLANTED. THE LEFT RENAL WAS SNORKELED SO THE PHYSICIAN COULD LAND THE CUFF AT THE HIGHER RIGHT RENAL. THE ENDOLEAK HAS RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED.  IT WAS NOTED THAT THE PATIENT WAS 6 FOOT 8 INCHES TALL AND OVER (B)(4) LBS. THIS MADE IT IMPOSSIBLE TO ACHIEVE THE NECESSARY PARALAX CORRECTION TO ENSURE PROPER PLACEMENT OF THE MAIN BODY DURING THE INDEX PROCEDURE. AS A RESULT, THE GRAFT WAS PLACED LOWER THAT THE SURGEON DESIRED RESULTING IN ENDOLEAK. IT WAS DECIDED TO SCHEDULE THE PATIENT FOR FURTHER INTERVENTION IN THE IR SUITE WHERE A MORE SUITABLE TABLE WOULD HELP WITH ACCURACY.  NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12460196 ↗
• InjuryMay 24, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 67MM AAA. IT WAS REPORTED THE PATIENT HAD PRESENTED WITH A SYMPTOMATIC IMPENDING RUPTURE. IT WAS REPORTED THE INDEX PROCEDURE WAS SUCCESSFUL, WITH REGRESSION OF THE ANEURYSM SAC NOTED ON ROUTINE FOLLOW UP VISITS. APPROX. 5 YEARS POT PROCEDURE, IT WAS REPORTED THE PATIENTS ANEURYSM BEGAN GROWING. THE ANEURYSM REACHED 11CM IN SIZE AND IT WAS DECIDED TO PERFORM OPEN REPAIR WITH EXPLANT OF THE STENT GRAFT WHICH WAS REPLACED WITH A SEWN IN AORTA FEMORAL BYPASS. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO A POSSIBLE TYPE II AND TYPE IA ENDOLEAK WITH IMPENDING LOSS OF SEAL PROXIMALLY. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE

  Patient problems: Aneurysm

  MAUDE report 11870913 ↗
• InjuryOct 29, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR FOLLOW UP APPROXIMATELY 5 YEARS POST INDEX PROCEDURE, A TYPE IA ENDOLEAK WAS OBSERVED. THE PATIENT WAS TREATED ON THE SAME DAY WITH THE IMPLANTATION OF AN ENDURANT 32 X 32 X 49 AORTIC CUFF, AND THE ENDOLEAK WAS RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9249281 ↗
• MalfunctionOct 17, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL ILIAC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE A TYPE 1A ENDOLEAK WAS OBSERVED. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED; CALCIFIED AORTA. NO INTERVENTION WAS PERFORMED AT THE TIME. 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 6953982 ↗
• InjurySep 14, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.3 CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN AND INCREASED CREATININE. A CT WAS PERFORMED AND AN APPROXIMATELY 12MM CAUDAL STENT GRAFT MIGRATION WAS DISCOVERED. A 36X36X49 ENDURANT CUFF WAS IMPLANTED TO RELINE UP TO THE RIGHT RENAL ARTERY. IVUS WAS PERFORMED TO CONFIRM THE RELATIVE LOCATION AND CIRCUMFERENTIAL APPOSITION OF THE GRAFT. THIS REPORTEDLY RESOLVED THE EVENT. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS ANATOMY RELATED. IT WAS FURTHER NOTED THAT THE FOLLOW UP CTA IDENTIFIED THAT THE PARA VISCERAL SEGMENT OF THE AORTA HAS DILATED TO GREATER THAN 36 MM. MODERATE AORTIC ANGULATION HAS ALSO INCREASED IN THE INFRARENAL SEGMENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain; Renal Failure

  MAUDE report 6864112 ↗
• InjuryJul 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HELI-FX APTUS ENDOANCHOR APPLIER WAS SELECTED FOR THE PROPHYLACTIC USE, TO PREVENT AORTIC NECK DILATATION, ALONG WITH AN ENDURANT STENT GRAFT SYSTEM FOR THE ENDOVASCULAR TREATMENT OF A 6.7 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON THE SAME DAY AS THE PROCEDURE, THE PATIENT HAD HYPERTENSION THAT WAS TREATED WITH MEDICATION. THE HYPERTENSION RESOLVED. THE INVESTIGATOR INDICATED THAT THE CAUSE OF THE HYPERTENSION IS UNCERTAIN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THE INVESTIGATOR.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 6721907 ↗
• InjuryApr 20, 2017Malposition of Device; Malposition of Device

  AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE CT REVEALED THAT THE ANEURX STENT GRAFT HAS MIGRATED 35 MM DISTALLY WITH A PROXIMAL TYPE I ENDOLEAK AND PRESSURIZING THE ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT BIFURCATED STENT GRAFT INSIDE OF THE ANEURX STENT GRAFT. HELI-FX APTUS ENDOANCHORS WERE IMPLANTED INTO THE ENDURANT BIFURCATED STENT GRAFT PROPHYLACTICALLY TO DISCOURAGE ADDITIONAL DISEASE PROGRESSION OF THE AORTIC NECK. HOWEVER, DURING THE IMPLANTATION OF THE APTUS ENDOANCHORS THE ENDURANT STENT GRAFT MOVED PROXIMALLY. AN ANGIOGRAM REVEALED THAT THE RIGHT SIDE OF THE ENDURANT STENT GRAFT MATERIAL WAS DEPLOYED PARTIALLY COVERING THE RENAL ARTERY, APPROXIMATELY 30%. THE MIGRATION AND THE PROXIMAL TYPE I ENDOLEAK WERE RESOLVED. ANOTHER ANGIOGRAM WAS PERFORMED AND THE RIGHT RENAL ARTERY WAS PERFUSING AT THE SAME RATE AS THE LEFT RENAL ARTERY VISUALLY, HOWEVER THE PHYSICIAN DECIDED TO INVESTIGATE FURTHER SEEKING TO CANNULATE THE RENAL ARTERY WITH A GUIDEWIRE AND CATHETER. UPON VISUAL REVIEW THE PHYSICIAN DETERMINED TO IMPLANT A RENAL STENT IN THE ART

  Patient problems: Occlusion

  MAUDE report 6508310 ↗
• InjuryMar 29, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH PAIN. THE CT REVEALED A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED PERFORM AN OPEN SURGICAL REPAIR WITH THE USE OF THE ENDURANT STENT GRAFTS AND SUTURES. THE PHYSICIAN DOES NOT KNOW THE CAUSE OF THE EVENT, AS THE PATIENT WAS IMPLANTED AT ANOTHER FACILITY AND PRESENTED EMERGENTLY FOR REPAIR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 6444899 ↗

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-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-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-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-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