Endurant® II ETBF3220C166ERecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00613994991027), received between May 2, 2017 and Jun 27, 2025 — classified as 1 death, 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2025Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN 80MM ABDOMINAL AORTIC ANEURYSM ADDITIONALLY, AN ENDURANT LIMB (ETLW1624C93E) WAS IMPLANTED APPROX. 8 YEARS POST INDEX PROCEDURE AND ANOTHER LIMB (ETLW1613C146E) WAS IMPLANTED APPROX. 10 YEARS POST INDEX PROCEDURE. ACCORDING TO THE PHYSICIAN, THESE WERE LIKELY USED TO ADDRESS DISEASE PROGRESSION DUE TO ANEURYSM EXPANSION INVOLVING THE ILIAC ARTERIES. IT WAS REPORTED DURING A FOLLOW UP VISIT APPROX. 12 YEARS, 5 MONTHS POST INDEX PROCEDURE, CT IMAGING CONFIRMED THE PRESENCE OF A TYPE II ENDOLEAK. THE PATIENT RECEIVED COIL TREATMENT, WHICH SUCCESSFULLY RESOLVED THE TYPE II ENDOLEAK THE EVENT WAS ATTRIBUTED TO THE PATIENT'S ANATOMY AND DISEASE PROGRESSION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aneurysm expansion

  MAUDE report 22344487 ↗
• InjuryApr 12, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY TO ER WITH A RUPTURED AAA. THE CT DID NOT SHOW AN ENDOLEAK BUT A INTERMITTENT TYPE IA ENDOLEAK WAS CONSIDERED. AAA MEASURES WERE 54X49MM WITH A SIGNIFICANT AMOUNT OF BLOOD IN THE RETROPERITONEUM. THE DEVICE WAS PLACED AT THE LOWEST LEFT RENAL ARTERY THEREFORE A CUFF WAS NOT ADDED. NO TYPE IA ENDOLEAK COULD BE SEEN ON ANGIOGRAM HOWEVER THE PHYSICIAN DECIDED TO IMPLANT 10 ENDOANCHORS. THERE WAS NO TYPE IB EITHER HOWEVER THE RIGHT LIMB HAD SEAL FOR 3CM BUT THERE WAS STILL 3CM TO THE HYPO AND IT DECIDED TO EXTENDED THE LIMB. IT WAS REPORTED THERE WAS ADEQUATE SEAL BUT THE PHYSICIAN WANTED TO MAXIMIZE COVERAGE. AFTER THE GROIN WAS CLOSED, THE PATIENT LOST THE PULSE IN HIS RIGHT GROIN AND LEG. THROMBECTOMY WAS ATTEMPTED SEVERAL TIMES WITHOUT ANY CLOT BEING REMOVED. PATIENT HAD DOPPLER SIGNALS IN BOTH FEET AT THE END OF THE CASE AND AS OF THIS MORNING. PER PHYSICIAN, THE PATIENT IS DOING WELL AND CONTINUES TO HAVE PULSES IN BOTH FEET. IT WAS REPORTED THE PATIENT RETURNED TO OPERATING ROOM AROUND A WEEK LATER FOR ANGIOGRAM AND CT SCAN SHOWED NEW THROM

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Obstruction/Occlusion; Rupture

  MAUDE report 14081773 ↗
• InjuryDec 15, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 65MM ABDOMINAL AORTIC AN EURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WHERE THE PHYSICIAN DISCOVERED THE PATIENT HAD A TYPE IA ENDOLEAK. THE PHYSICIAN DECIDED TO IMPLANT A CUFF WHICH RESOLVED THE ENDOLEAK.  AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO THE PATIENTS OWN ANATOMY AS A RESULT OF DISEASE PROGRESSION AS THE NECK CONTINUED TO DILATE. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 13009369 ↗
• MalfunctionNov 12, 2020Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM. A CT PERFORMED OVER 7 YEARS LATER REVEALED A TYPE IA AND TYPE II ENDOLEAK FROM LUMBAR ARTERIES AND A SAC DIAMETER OF 65MM. DURING THE SAME CT, IT WAS FOUND THE PATIENT HAD A NEW THORACIC PAU (PENETRATING ATHEROSCLEROTIC ULCERS (PAU). THE PHYSICIAN DECIDED TO TREAT THE PAU 3 DAYS LATER. TWO VALIANT NAVION STENT GRAFTS WERE IMPLANTED AS TREATMENT. IT WAS REPORTED THAT SHORTLY AFTER THIS PROCEDURE, THE PATIENT SUFFERED A CEREBRAL VASCULAR ACCIDENT (CVA) AND WAS RECOVERING IN HOSPITAL. AS PER THE PHYSICIAN, THE CAUSE OF THE CVA WAS UNCONTROLLABLE HIGH BLOOD PRESSURE. THE CAUSE OF THE IA ENDOLEAK WAS ANATOMY AND A HOSTILE ANGLED AORTIC NECK WITH CONTINUED DILATION OF THE AORTA. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: High Blood Pressure/ Hypertension; No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient; Stroke/CVA

  MAUDE report 10828482 ↗
• InjuryOct 22, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 98M ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE, FOLLOW UP IMAGING IDENTIFIED A TYPE IA ENDOLEAK. AS THERE WAS NO MORE PROXIMAL NECK FOR EXTENSION THE PHYSICIAN PERFORMED AN OFF LABEL REPAIR UTILIZING A THORACIC VALIANT NAVION DEVICE IN CONJUNCTION WITH A LEFT RENAL FENESTRATION AND A RIGHT RENAL AND SMA SNORKEL. AT THE END OF THE REPAIR A SLIGHT TYPE IA ENDOLEAK WAS STILL DEMONSTRATED. THE PHYSICIAN ELECTED TO END THE PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK WAS ANATOMY RELATED DUE TO DISEASE DEGENERATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury

  MAUDE report 10717249 ↗
• InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON AN UNKNOWN DATE, FOLLOW UP WITH THE PHYSICIAN NOTED THAT THE ABDOMINAL AORTIC SAC GREW FROM 50MM TO 60MM WITHOUT EVIDENCE OF AN ENDOLEAK. THE PHYSICIAN ELECTED TO RELINE THE EXISTING GRAFT AS A PRECAUTIONARY MEASURE. APPROXIMATELY ONE MONTH LATER, INTERVENTION WAS COMPLETED BY IMPLANTING AN ENDURANT 36X36X49 PROXIMAL CUFF, 16X24X156 LEFT ILIAC LIMB AND 16X20X124 RIGHT LIMB. FINAL RUN SHOWED NO ENDOLEAK AT ALL WHICH IS WHAT INITIAL RUN SHOWED. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm

  MAUDE report 8806595 ↗
• MalfunctionApr 5, 2019Material Deformation; Material Deformation

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT PHONED TECHNICAL SERVICES AND REPORTED A BACK X-RAY TAKEN APPROXIMATELY 3 YEARS 10 MONTHS POST IMPLANT HAS IDENTIFIED A BULGE WITHIN THE STENT GRAFT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8486085 ↗
• InjuryFeb 27, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON FOLLOW UP IT WAS NOTED THAT THE PATIENT HAD A TYPE IA ENDOLEAK DUE TO DISEASE PROGRESSION. ONE DAY LATER, INTERVENTION WAS PERFORMED WITH THE IMPLANTATION OF 10 ENDOANCHORS BUT THE TYPE IA ENDOLEAK PERSISTED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS ANATOMY RELATED DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury

  MAUDE report 8373214 ↗
• InjuryAug 8, 2017Malposition of Device; Malposition of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.0 CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT, DURING THE INDEX PROCEDURE, THE STENT GRAFT LANDED APPROXIMATELY 1 CM LOWER THAN THE LOWER LEFT RENAL WHICH WAS THE INTENDED TARGET. A 32 X 32 X 49 CUFF WAS IMPLANTED AT THE INTENDED TARGET. NO ENDOLEAK WAS OBSERVED AND THE EVENT WAS 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: Injury

  MAUDE report 6773659 ↗
• DeathMay 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A COMMERCIALLY AVAILABLE ENDURANT II LIMB WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AS PART OF THE IMPLANT OF A NON-COMMERCIALLY AVAILABLE TVAAA DEVICE. IT WAS NOTED THAT THE DIAMETER OF THE AORTA AT THE DIAPHRAGM MEASURED 36MM AT THE TIME OF INTERVENTION. IT WAS REPORTED THAT THE PATIENT WAS INTUBATED FOR AN EXTENDED PERIOD OF TIME AS IT TOOK LONGER THAN EXPECTED FOR HIM TO WEAN OFF THE VENT. WHILE INTUBATED, AND AFTER EXTUBATION, THE SUBJECT HAD A STRONG COUGH. POST OPERATIVELY, THE PATIENT¿S BLOOD PRESSURE CONTINUED TO INCREASE WITH THE HIGHEST BLOOD PRESSURES MEASURED BEING 232/65 MMHG ON POST OP DAY 2 AND 212/99 MMHG ON POST OP DAY 3. THEY WERE TREATED WITH IV ANTIHYPERTENSIVE MEDICATIONS AS WELL AS HIS HOME REGIMEN OF ANTIHYPERTENSIVE MEDICATIONS TO DECREASE HIS BLOOD PRESSURE. DURING THE TIME OF INCREASED HYPERTENSION, THIS PATIENT HAD SEVERAL SIGNIFICANT COUGHING EVENTS. ON POST OP DAY 6, A CTA OF THE CHEST, ABDOMEN, AND PELVIS WERE COMPLETED AND A RETROGRADE TYPE B AORTIC DISSECTION WAS DISCOVERED IN THE DESCENDING THORACIC AORTA EXTENDING PROXIMALLY FROM THE VTAAA THORACIC BIFURCATION STENT GRAFT. THE PATIENT¿S BLOOD PRESSUR

  Patient problems: Death; High Blood Pressure/ Hypertension; Neurological Deficit/Dysfunction; Vascular Dissection; Weakness

  MAUDE report 6541441 ↗
• InjuryMay 2, 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 ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE ENDURANT BIFURCATE LOST SEAL AND MIGRATED. A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED. IT WAS NOTED THAT THE DIAMETER OF THE AORTA AT THE DIAPHRAGM MEASURED 36MM AND THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 7.7 CM. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH A NON-COMMERCIAL TVAAA DEVICE. AN ANGIOGRAM DEMONSTRATED GOOD FLOW TO THE CELIAC, SMA, RENALS, AS WELL AS FLOW TO THE INFRARENAL SEGMENT AND ILIAC ARTERIES THROUGH THE VISCERAL MANIFOLD DEVICE. NO ARTERIAL INJURIES WERE NOTED AT THE ACCESS SITES AND DOPPLERABLE PULSES WERE CONFIRMED IN BILATERAL LOWER EXTREMITIES AND THE UPPER ACCESS EXTREMITY. THERE WAS NO EVIDENCE OF AORTIC DISSECTION ON THE COMPLETION ANGIOGRAM. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO PROXIMAL DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6539180 ↗

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-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