Endurant® II ETBF2820C166ERecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00613994990969), received between Apr 12, 2017 and Mar 25, 2024 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2024Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 65MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 6 YEARS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH ABDOMINAL PAIN. CT DEMONSTRATED AN ENDOLEAK AND CONTAINED HAZINESS AROUND THE AAA. THE PATIENT WAS BROUGHT TO OR WHERE DIAGNOSTIC ANGIOGRAM DETERMINED IT WAS A TYPE IIIB FABRIC TEAR IN THE DISTAL MAINBODY OF THE ENDOGRAFT POSSIBLY NEAR THE BIFURCATION OF THE GRAFT. A 28 AUI DEVICE WAS PLACED WITH A 16MM ENDURANT LIMB IN ADDITION TO A FEM- FEM BYPASS TO SUCCESSFULLY COVER THE TEAR. THE CAUSE OF THE TEAR IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WAS REPORTED AND THE PATIENT IS FINE.

  Patient problems: Abdominal Pain

  MAUDE report 18969426 ↗
• MalfunctionSep 4, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED BY THE PATIENT THROUGH TECHNICAL SERVICES, THAT THEY HAVE BEEN DIAGNOSED WITH AN UNKNOWN TYPE ENDOLEAK WHICH HAD NOT RECEIVED ANY TREATMENT AS YET. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10492898 ↗
• InjuryNov 14, 2018Migration or Expulsion of Device; Malposition of Device; Migration or Expulsion of Device; Malposition of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 65MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A CT SCAN CARRIED OUT APPROXIMATELY THREE YEARS LATER SHOWED A 1CM GAP FROM THE TOP OF THE GRAFT TO THE LOWEST RENAL ARTERY BUT THERE DID NOT APPEAR TO ANY TYPE IA ENDOLEAK. AN INTERVENTION PROCEDURE WAS CARRIED OUT AND AN 28X28X49 ENDURANT CUFF WAS PLACED TO EXTEND PROXIMALLY TO THE LEVEL OF THE LOWEST RENAL ARTERY. THE CUFF WAS BALLOONED AND AN AORTOGRAM SHOWED NO ENDOLEAK. THE EVENT WAS REPORTED TO BE RESOLVED. THE CAUSE OF THE MIGRATION IS CURRENTLY UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8068289 ↗
• MalfunctionAug 31, 2018Leak/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 APPROXIMATELY 5 AND A HALF YEARS LATER A CT SCAN ON THE PATIENT IDENTIFIED A TYPE IA ENDOLEAK. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO DISEASE PROGRESSION WHICH CAUSED THE NECK TO DILATE AWAY FROM THE STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7836507 ↗
• InjuryAug 30, 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 60MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY A YEAR LATER A CT SCAN IDENTIFIED A TYPE IB ENDOLEAK. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS DUE TO THE LIMBS LOSING DISTAL SEAL DUE TO PROXIMAL MIGRATION AND DISEASE PROGRESSION. AN ENDURANT II ILIAC EXTENSION ETEW2020C82E AND ENDURANT II LIMB ETLW1616C93E WERE IMPLANTED TO TREAT THE ENDOLEAK. POST IMPLANTATION OF THE LIMBS AN ANGIOGRAM SHOWED ONLY A TYPE II ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury

  MAUDE report 7832078 ↗
• InjuryAug 28, 2018Leak/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 APPROXIMATELY FOUR MONTHS LATER, THE PATIENT HAD A TYPE IB ENDOLEAK. THE RIGHT STENT GRAFT LIMB HAD MIGRATED TO A POSITION AWAY FROM THE RIGHT ILIAC AND INTO THE ANEURYSM SAC. THE PATIENT RECEIVED TREATMENT WITH THE ADDITION OF A STENT GRAFT LIMB AT THE FLOW DIVIDER OF EXISTING MAIN STENT GRAFT BODY AND AN EXTENSION TO THE RIGHT EXTERNAL ILIAC. THE RIGHT HYPOGASTRIC WAS ALSO EMBOLIZED AND THE ENDOLEAK WAS CONFIRMED AS RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS SUSPECTED TO BE ANATOMY RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7822048 ↗
• InjuryApr 12, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 7.0 CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT RETURNED FOR FOLLOW UP AND A TYPE IB ENDOLEAK WAS DISCOVERED IN THE RIGHT ILIAC. THE RIGHT HYPOGASTRIC ARTERY WAS COILED AND THE LIMB WAS EXTENDED INTO THE EXTERNAL ILIAC ARTERY. THIS REPORTEDLY RESOLVED THE EVENT. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS DUE TO PATIENT ANATOMY; SPECIFICALLY, DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6486792 ↗

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-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