Endurant® II ETUF2514C102ERecalls & reported problems
Medtronic, Inc. · STENT GRAFT ETUF2514C102E ENDUR II AUI · Class 3 · Implant
All models of Endurant II (114)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 13
- Deaths reported
- 3
- Injuries reported
- 9
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169232570), received between Jan 4, 2017 and Oct 24, 2025 — classified as 3 deaths, 9 injuries, 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (5 reports).
2 FDA recall records name this device's identifier, 2 still open.
5 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.
Reports received per month
Recalls naming this device
- Dec 21, 2021Class IIOpen, 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 ↗
- Oct 15, 2021Class IIOpen, Classified
Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
Z-0291-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Leak/Splash5
- Adverse Event Without Identified Device or Use Problem4
- Difficult to Remove2
- Activation, Positioning or Separation Problem1
- Device Damaged by Another Device1
- Malposition of Device1
- Material Deformation1
- Positioning Problem1
Patient problems
- Injury5
- Hemorrhage/Blood Loss/Bleeding2
- Low Blood Pressure/ Hypotension2
- Abscess1
- Anemia1
- Cardiac Arrest1
- Device Embedded In Tissue or Plaque1
- Insufficient Information1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
DeathOct 24, 2025Activation, Positioning or Separation Problem; Material Deformation; Positioning Problem; Activation, Positioning or Separation Problem; Material Deformation; Positioning Problem
AN ENDURANT AUI STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM. IT WAS NOTED THAT THE INFRARENAL NECK LENGTH MEASURED APPROX. 20MM. IT WAS REPORTED THAT DURING THE PROCEDURE, A NON-MEDTRONIC GUIDEWIRE (LUNDERQUIST), WAS PLACED IN THE AORTIC ARCH THROUGH AN 18FR NO N-MEDTRONIC SHEATH (DRYSEAL) VIA THE LEFT COMMON FEMORAL ARTERY. A PREVIOUSLY PLACED 5 FR CATHETER WAS PLACED IN THE LEFT RADIAL ARTERY AND A 5FR PIGTAIL CATHETER WAS DELIVERED. ANGIOGRAPHY WAS PERFORMED AND AN AREA BETWEEN THE RIGHT RENAL ARTERY AND SECONDARY AOR TIC BEND WAS CHOSEN AND MARKED FOR DEVICE DELIVERY. THE STENT GRAFT WAS DELIVERED TO THE TARGET SITE. THE PHYSICIAN DESCRIBED ALL THESE PREVIOUS STEPS AS DIFFICULT AND MENTIONED THAT THE ANATOMY WAS DIFFICULT TO NAVIGATE. THE STENT GRAFT DEPLOYMENT BEGAN AT THE TARGET SITE AND PRIOR TO 2 FULL STENT RINGS WAS PULLED BACK TO THE TARGET SITE. THE DEPLOYMENT OF THE STENT CONTINUED UNTIL THERE WERE 3 STENT RINGS STILL CONSTRAINED WITHIN THE DELIVERY SHEATH. AT THAT TIME, THE PHYSICIAN BEGAN DEPLOYMENT OF THE BACK THUMB WHEEL TO RELEASE THE TIP CAPTURE AND DEPLOY THE SUPRARENAL STENT. IT WAS OBSERVED THAT THE MOVEMENT W
Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation of Vessels
MAUDE report 23377465 ↗InjurySep 30, 2024Leak/Splash; Leak/Splash
AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 60MM AAA. AN ENDURANT CUFF ETCF2828C49E WAS IMPLANTED 10 YEARS AND FIVE MONTHS LATER DUE TO A TYPE IA ENDOLEAK WHICH WAS IDENTIFIED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY THE FOLLOWING MONTH AND A IB ENDOLEAK WAS OBSERVED IN THE LEFT ILIAC LIMB ETLW1613C93E . INTERVENTION WAS PERFORMED ON THE SAME DAY AND A LIMB EXTENSION WAS IMPLANTED. THIS RESOLVED THE IB ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE IB ENDOEAK WAS ANATOMY RELATED DUE TO ILIAC DISEASE PROGRESSION. NO CAUSE OF THE IA ENDOLEAK WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.
Patient problems: Insufficient Information
MAUDE report 20331559 ↗DeathMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 50MM AAA. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE BIFURCATE MAIN BODY WAS PLACED WITHOUT ISSUE, THE PHYSICIAN HAD MUCH DIFFICULTY CANNULATING THE GATE AND MUCH TIME WAS SPENT UTILIZING MANY TACTICS TO DO SO. THE PHYSICIAN PROCEEDED TO COMPLETE THE ISPI (RIGHT) SIDE BY REMOVING THE MAIN BODY'S DELIVERY SYSTEM AND COMPLETING RIGHT SIDE BY ADDING A ETLW1610C82E (B)(6)) WITHOUT ISSUE. THE PHYSICIAN THEN BEGAN ATTEMPTING TO CANNULATE THE GATE AGAIN. AT THIS TIME THE ANESTHESIOLOGIST ALERTED THE PHYSICIAN TO A SLOWLY DECLINING BLOOD PRESSURE. CONTRAST WAS THEN INJECTED TO VISUALIZE THE LEFT ILIAC BUT NO EXTRAVASATION WAS SEEN. THE PHYSICIANS ALSO PERFORMED AN ANGIOGRAM WITH A CATHETER PROXIMAL TO RENAL ARTERIES AND NOTED NO EXTRAVASATION. THE ANESTHESIOLOGIST STABILIZED THE PATIENT AS THE PHYSICIAN CONTINUED TO TRY TO CANNULATE THE GATE. THE PATIENTS BLOOD PRESSURE DROPPED AGAIN AND A REPEAT ANGIOGRAM SHOWED EXTRAVASATION IN THE PROXIMAL LEFT ANEURYSM. AN ENDURANT AUI WAS THEN PLACED ALONG WITH A NON MDT VASCULAR PLUG TO OCCLUDE THE LEFT ILIAC ARTERY, THEREBY EXCLUDING FLOW INTO T
Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension
MAUDE report 16982744 ↗InjuryApr 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN ENDURANT II AUI STENT GRANT AND LIMB WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A ABDOMINAL AORTIC ANEURYSM AND OCCLUSIVE DISEASE. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY 3 AND A HALF MONTHS LATER WITH A COLD LEG. A CT PERFORMED SHOWED A CLOT WAS PRESENT DISTALLY AND OCCLUDED THE STENT IN THE SFA ALL THE WAY TO THE POPLITEAL. INTERVENTION WAS PERFORMED, THE AUI WITH A ETUF 23X14X102 AND EXTENDED DOWN TO THE LEIA WITH A 16X10 LIMB AND THEN DID A BYPASS TO THE POPLITEAL. THIS RESOLVED THE EVENT. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.
Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus
MAUDE report 11731090 ↗MalfunctionAug 13, 2020Difficult to Remove; Device Damaged by Another Device; Difficult to Remove; Device Damaged by Another Device
AN ENDURANT AUI STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR A CHEVAR PROCEDURE IN THE TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE RIGHT RENAL SHEATH BECAME ENTANGLED WITH THE SUPRARENAL STENTS. AFTER MUCH EFFORT, THE PHYSICIAN WAS ABLE TO REMOVE THE SHEATH, HOWEVER IT WAS FRACTURED AND PART OF THE SHEATH WITH THE WIRE REMAINS IN THE PATIENT. THE CAUSE OF THE EVENT WAS NOT DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10401089 ↗InjuryFeb 4, 2020Difficult to Remove; Difficult to Remove
AN ENDURANT II AUI STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 56MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, AFTER DEPLOYMENT OF THE DEVICE, THE DELIVERY SYSTEM BECAME STUCK PROXIMALLY AT THE LEVEL OF AN EXISTING STENT. THE DELIVERY SYSTEM WOULD NOT ADVANCE INTO THE ABDOMINAL AORTA AT THIS POINT. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO GAIN ACCESS FOR ANY ADJUNCTIVE TROUBLESHOOTING TECHNIQUES. THE DECISION WAS MADE TO GAIN PROXIMAL ACCESS AND DISSECT TO THE LEVEL OF THE PROXIMAL DELIVERY CATHETER, THE DELIVERY SYSTEM WAS THEN CUTDOWN AND REMOVED SUCCESSFULLY A NON-MDT CONDUIT GRAFT WAS IMPLANTED AT THE RIGHT FEMORAL ARTERY. THE REMAINING PROCEDURE WAS REPORTED TO BE COMPLETED IN THE USUAL WAY AND THE PATIENT REMAINED STABLE THROUGHOUT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY. IT WAS NOTED THAT THE PATIENT'S PERIPHERAL ARTERY DISEASE, SMALL CALCIFIED ACCESS AND PRIOR INTERVENTIONS WOULD HAVE CONTRIBUTED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Injury
MAUDE report 9665076 ↗InjuryNov 21, 2019Leak/Splash; Leak/Splash
AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 48 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 5 YEARS POST INDEX PROCEDURE THAT ONGOING ANEURYSM SAC ENLARGEMENT HAD BEEN OBSERVED FOR SOME TIME WITH NO IDENTIFIABLE CAUSE. THE PHYSICIAN ELECTED TO SURGICALLY OPEN THE SAC AND LIGATE THE VESSELS THAT WERE CONTRIBUTING TO THE INCREASING SIZE OF THE SAC. DURING THE PROCEDURE A TYPE IIIB ENDOLEAK WAS IDENTIFIED WHERE BLOOD WAS OBSERVED SQUIRTING THROUGH THE SUTURE LINE OF THE AUI STENT GRAFT. SURGICAL GLUE WAS PLACED ON THE GRAFT AND AN ADDITIONAL PROCEDURE WAS FURTHER COMPLETED WHERE THE STENT GRAFT WAS RELINED AND THE ENDOLEAK CONFIRMED AS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE ENLARGEMENT WAS DUE TO A TYPE IIIB ENDOLEAK. THE CAUSE OF THE TYPE IIIB ENDOLEAK WAS DETERMINED TO BE DUE TO A STENT GRAFT FAILURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.
Patient problems: Injury
MAUDE report 9353065 ↗InjuryMar 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A MACULOPAPULAR RASH ON THE ABDOMEN AT THEIR FOLLOW UP FOUR MONTHS POST THE INDEX PROCEDURE. THE PATIENT WAS REFERRED TO A DERMATOLOGIST BUT THE RESULTS FROM THIS APPOINTMENT ARE STILL PENDING. THE PATIENT IS DUE FOR ANOTHER FOLLOW UP IN 6 MONTHS TIME. THE PATIENT IS BEING SEEN BY AN ALLERGIST WHO IS INVESTIGATING THE PRODUCT MATERIALS. IT WAS REPORTED THAT THE PATIENT HAS SUFFERED FROM HIVES OVER THEIR ENTIRE BODY SINCE THE STENT GRAFT IMPLANT.
Patient problems: Reaction
MAUDE report 8432420 ↗InjuryMar 1, 2017Leak/Splash; Leak/Splash
AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT AN ABDOMINAL AORTIC ANEURYSM. IT WAS NOTED THAT BOTH RENAL ARTERIES WERE ALSO STENTED. IT WAS REPORTED THAT THERE WAS A PROXIMAL TYPE I ENDOLEAK POST PROCEDURE AND APTUS ENDOANCHORS WERE IMPLANTED. THE PATIENT EXPERIENCED BILATERAL GROIN PAIN, REQUIRED SEVERAL TRANSFUSIONS FOR SYMPTOMATIC ANEMIA, AND DEVELOPED A LARGE GROIN HEMATOMA. THE PATIENT WAS PLACED IN THE INTENSIVE CARE UNIT, RECEIVED MEDICATION, AND THE EVENT WAS RESOLVED. THE ANEURYSM SAC NO LONGER HAD FLOW AND THE MAXIMUM ANEURYSM DIAMETER HAD DECREASED TO 5.8 CM. THE INVESTIGATOR INDICATED THAT THE PROXIMAL TYPE I ENDOLEAK WAS RELATED TO THE INDEX PROCEDURE BUT DID NOT INDICATE IF RELATED TO DEVICE. PER THE PHYSICIAN, THE SMALL PROXIMAL TYPE I ENDOLEAK HAD SIGNS OF THROMBOSIS THAT SUGGESTED SOME DEPRESSURIZATION OF THE SAC SPONTANEOUSLY. THE INVESTIGATOR INDICATED THAT THE SYMPTOMATIC ANEMIA SECONDARY TO LARGE GROIN HEMATOMA WAS RELATED TO THE INDEX PROCEDURE BUT DID NOT INDICATE IF RELATED TO DEVICE. IT WAS ADDITIONALLY REPORTED THAT APPROXIMATELY 5 WEEKS POST IMPLANT, THE PATIENT DEVELOPED AN INFECTION OF THE FEMORAL-FEMORAL BYPAS
Patient problems: Abscess; Anemia; Unspecified Infection
MAUDE report 6370592 ↗DeathFeb 17, 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 8.1 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. AT THE ORIGINAL IMPLANT, THE ISPI LIMB OF THE BIFURCATE WAS IMPLANTED ON THE LEFT SIDE AND THE CONTRA LIMB WAS IMPLANTED ON THE RIGHT SIDE. VESSEL MORPHOLOGY AT IMPLANT WAS REPORTED AS SHORT (10 MM), SEVERELY ANGULATED AND 21 MM IN DIAMETER AORTIC NECK. THE PATIENT DID NOT RETURN FOR FOLLOW UP APPOINTMENTS. THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED JUXTARENAL 13CM ANEURYSM. IT WAS REPORTED THAT THE ENDURANT BIFURCATED STENT GRAFT REMAINED IN PLACE AT THE LOWEST RENAL ARTERY, BUT THE AORTA AT THE RENAL ARTERIES WAS ANEURYSMAL. THE LEFT COMMON ILIAC ARTERY THAT WAS 10MM IN DIAMETER AT THE INDEX PROCEDURE AND IS CURRENTLY OVER 30 MM IN DIAMETER. THE PHYSICIAN EMERGENTLY EXTENDED UP THE RIGHT LIMB TO THE SMA WITH AN ENDURANT AUI STENT GRAFT. THE PATIENT¿S RENAL ARTERIES WERE INTENTIONALLY COVERED TO SEAL THE ANEURYSM. THEREFORE, THE PATIENT WILL REQUIRE DIALYSIS. THERE WAS GOOD PROXIMAL SEAL; HOWEVER IT WAS NOTICED THAT THERE WAS A DISTAL TYPE I ENDOLEAK IN THE RIGHT ILIAC. THE PHYSICIAN EXTENDED THE RIGHT LIMB WITH AN ENDURANT 16X16X93 LIM
Patient problems: Stroke/CVA
MAUDE report 6341760 ↗InjuryFeb 1, 2017Leak/Splash; Leak/Splash
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.3 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE AORTIC WAS SHORT IN LENGTH AND CALCIFIED. IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE THE ENDURANT AUI STENT GRAFT HAD A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT FOUR APTUS ENDOANCHORS; HOWEVER, THE PROXIMAL TYPE I ENDOLEAK WAS NOT COMPLETELY RESOLVED. THE PHYSICIAN STATED THAT THE EVENT IS RELATED TO THE PATIENT¿S ANATOMY OF A SHORT AND CALCIFIED PROXIMAL AORTIC NECK. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Injury
MAUDE report 6294308 ↗InjuryJan 26, 2017Leak/Splash; Leak/Splash
AN ENDURANT II AORTO-UNI-ILIAC STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 45 MM IN DIAMETER SACCULAR ABDOMINAL AORTIC ANEURYSM. APTUS ENDOANCHORS WERE INITIALLY IMPLANTED AS A PROPHYLACTIC. THERE WAS PROXIMAL AORTIC NECK CALCIFICATION. THE LEFT AND RIGHT ILIAC ARTERIES WERE CALCIFIED. THE ACCESS VESSELS WERE SMALL AND DISEASED. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED AFTER IMPLANTING THE ENDURANT II STENT GRAFT SYSTEM AND FOUR APTUS ENDOANCHORS. THE PHYSICIAN ELECTED TO IMPLANT FOUR ADDITIONAL APTUS ENDOANCHORS IN THE INFRARENAL AORTIC NECK AND BALLOONED THE AREA BUT THE ENDOLEAK DID NOT RESOLVE. THE PHYSICIAN THEN OBSERVED A SPIRAL DISSECTION IN THE LEFT ILIAC ARTERY WITH RETROGRADE FLOW INTO THE ABDOMINAL AORTIC ANEURYSM SAC. THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE WITH A FEMORAL TO FEMORAL ARTERY BYPASS AND AN ILIAC LIGATION. THE PROXIMAL TYPE I ENDOLEAK WAS STILL PRESENT AT THE END OF THE PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE PROXIMAL TYPE I ENDOLEAK WAS POSSIBLY DUE TO AN ANGULATED PROXIMAL AORTIC NECK. THE PHYSICIAN STATED THAT THE DISSECTION OCCURRED DUE TO DILATION OF
Patient problems: Injury
MAUDE report 6280640 ↗InjuryJan 4, 2017Malposition of Device; Malposition of Device
AN ENDURANT II AORTO-UNI-ILIAC STENT GRAFT WAS IMPLANTED FOR THE TREATMENT OF A 50 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE AN ANGIOGRAM REVEALED THAT THE ENDURANT II AORTO-UNI-ILIAC STENT GRAFT WAS DELIVERED APPROXIMATELY 8 MM DISTAL TO THE DESIRED LOCATION. NO ENDOLEAKS WERE OBSERVED. THE PHYSICIAN ELECTED TO IMPLANT A PROXIMAL 25X25X49 ENDURANT CUFF AND A FINAL ANGIOGRAM REVEALED NO ENDOLEAKS. THE EVENT WAS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS RELATED TO USER ERROR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Injury
MAUDE report 6222586 ↗
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, ClassifiedEndurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
- Z-0292-2022 · Oct 15, 2021 · Open, ClassifiedEndurant 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, ClassifiedEndurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infra
- Z-2136-2021 · Jun 7, 2021 · Open, ClassifiedMedtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoili
- Z-1543-2017 · Feb 27, 2017 · TerminatedEndurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E ETBF2513C166E ETBF2313C166E ETBF2316C166
Other SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices
- Endurant® IIs ESBF2814C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls34 deaths254 reports
- Endurant® IIs ESBF3214C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls19 deaths173 reports
- Endurant® IIs ESBF3614C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall37 deaths214 reports
- Endurant® IIs ESBF2514C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls18 deaths136 reports
- Endurant® IIs ESBF2314C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls9 deaths60 reports
- RelayPro Thoracic Stent-Graft System 28-N4-34-154-34UBolton Medical Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment3 recalls7 reports
- Vela Proximal Endograft System A34-34/C100-O20 VEndologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment3 deaths152 reports
- Endurant® II ETCF2828C49EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls7 deaths44 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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