Endurant® II ETLW1610C93E (UDI 00643169467606)Recalls & reported problems
Medtronic, Inc. · STENT GRAFT ETLW1610C93E ENDUR II LIMB · Class 3 · Implant
All models of Endurant II (114)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 1
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00643169467606), received between Mar 1, 2017 and Jan 22, 2026 — classified as 1 death, 12 injuries, 1 malfunction.
The most frequently reported specific device problem is “Occlusion Within Device” (3 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem8
- Occlusion Within Device3
- Defective Component1
- Device Markings/Labelling Problem1
- Leak/Splash1
- Malposition of Device1
- Material Deformation1
Patient problems
- Injury3
- Occlusion3
- Pain3
- Insufficient Information2
- Obstruction/Occlusion2
- Perforation of Vessels2
- Unspecified Infection2
- Abscess1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
DeathJan 22, 2026Material Deformation; Adverse Event Without Identified Device or Use Problem
AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 54MM ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS NOTED THAT THE PHYSICIAN PERFORMED BILATERAL CUTDOWNS AND THE BEGINNING OF THE PROCEDURE AND WAS ASSISTED BY TWO FELLOW DOCTORS. DURING THE INDEX PROCEDURE, THE FINAL ANGIOGRAM APPEARED EXCELLENT, WITH NO ISSUES NOTED, AND THE CASE WAS DEEMED A SUCCESS. HOWEVER, IT WAS REPORTED THAT DURING CLOSURE, THE PATIENT'S BLOOD PRESSURE DROPPED, AND ALL VASCULAR ACCESS WAS LOST. THE PHYSICIAN QUICKLY REGAINED ACCESS, INSERTED A 16FR SHEATH, AND INFLATED A RELIANT BALLOON WITHIN THE BODY OF THE STENT GRAFT FROM THE LEFT SIDE. IT WAS SAID THAT THE RELIANT BALLOON HELPED DURING THE PROCEDURE, AS IT ALLOWED THE PHYSICIAN GAIN ACCESS ON THE OPPOSITE SIDE. IT WAS NOTED THAT DURING CLOSURE, THE RIGHT LIMB OF THE STENT GRAFT (ETLW1610C93E, SERIAL#: (B)(6) WAS CRUSHED UPWARDS, RESULTING IN A RUPTURE OF THE RIGHT COMMON ILIAC ARTERY. THE PHYSICIAN PROMPTLY RE-LINED THE STENT GRAFT USING A NON-MEDTRONIC STENT GRAFT. DESPITE THESE EFFORTS, THE PATIENT PASSED AWAY ON THE TABLE. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE EVENTS, INCLUDING THE PATIENT'S DEATH, CANNOT BE DET
Patient problems: Insufficient Information; Low Blood Pressure/ Hypotension; Perforation of Vessels
MAUDE report 24142712 ↗InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 7 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN. IT WAS IDENTIFIED THAT THE LEFT LIMB ETLW1610C93E WAS THROMBOSED WITH NO OUTFLOW. IT WAS CONFIRMED THAT THE OCCLUSION WENT ALL UP TO THE MAIN BODY FLOW DIVIDER. INTERVENTION WAS PERFORMED THE NEXT DAY WHERE THE LIMB WAS DE-CLOTTED USING NON- MEDTRONIC CATHETERS. THE LIMB WAS THEN RE-LINED WITH ANOTHER LIMB 16X10X93 LIMB AND TWO 9X39 BARE METAL STENTS WERE PLACED AT THE AORTIC BIFURCATION. FLOW WAS RESTORED TO LEFT ILIAC LIMB. PER THE PHYSICIAN, THE CAUSE OF THE OCCLUSION WAS ANATOMY RELATED, WHICH WAS CAUSING THE RIGHT ILIAC LIMB TO COMPRESS THE LEFT ILIAC LIMB REDUCING THE FLOW LUMEN DIAMETER AND OUTFLOW. NO ADDITIONAL SEQUELA WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Obstruction/Occlusion; Pain
MAUDE report 19277230 ↗InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA. IT WAS REPORTED THAT A CT PERFORMED ON AN UNKNOWN DATE, IDENTIFIED A POSSIBLE TYPE IA ENDOLEAK. UPON FURTHER REVIEW OF THE CT, THERE WAS SOME CONTRAST NOTED AROUND THE PROXIMAL END OF THE GRAFT AND THE RIGHT RENAL ARTERY WAS NO LONGER FUNCTIONING. IT WAS REPORTED THAT THE RIGHT RENAL KIDNEY FAILURE WAS AN ACCIDENTAL FINDING ON THE CT. THE REDUCED RENAL FUNCTION WAS NOT A RESULT OF THE ENDOLEAK AND WAS NOT CAUSED BY THE STENT GRAFT. THERE WAS ABOUT 15MM OF SPACE ABOVE THE BIFURCATE GRAFT. APPROXIMATELY 8 YEARS AND 5 MONTHS AFTER THE INDEX PROCEDURE, , THE PHYSICIAN PLACED AND ENDURANT 26 X 36 X 49 AORTIC CUFF INSIDE THE BIFURCATE UP TO THE LEVEL OF THE RENAL ARTERY. THE CUFF WAS THEN BALLOONED. AN ANGIOGRAM WAS PERFORMED AND THE APPARENT LEAK WAS RESOLVED. DURING THE FINAL ANGIOGRAM, IT WAS NOTED THAT BOTH COMMON ILIAC ARTERIES HAD EXPANDED DISTAL TO THE GRAFT LIMBS. THERE WAS NO APPARENT ENDOLEAK OR LOSS OF DISTAL SEAL, BUT THE PHYSICIAN DECIDED TO THEN EXTEND BOTH LIMBS TO PREVENT ANY FURTHER DILATION. THE PHYSICIAN PLACED A 16X16X93 IN BOTH ILIAC ARTERIES EXTENDING DOWN TO THE INTE
Patient problems: Insufficient Information
MAUDE report 18515959 ↗InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN ENDURANT LIMB (ETLW1610C93E) AND AN ENDURANT EXTENSION (ETEW2020C82E) WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A RUPTURED ILIAC ARTERY ANEURYSM . THE TREATMENT WAS SUCCESSFUL IN COVERING THE LEAK. IT WAS REPORTED POST-OPERATIVELY ON AN UNKNOWN DATE, DURING ROUTINE INPATIENT FOLLOW UP, IT WAS NOTED THE PATIENT HAD AN INFECTION . EIGHT DAYS POST THE IMPLANT ,THE DECISION WAS MADE TO EXPLANT THE IMPLANTED DEVICES DUE TO THE INFECTION AND THE STENT GRAFTS WERE EXPLANTED. PER THE PHYSICIAN THE CAUSE OF THE INFECTION WAS NOT SPECIFIED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.
Patient problems: Unspecified Infection
MAUDE report 18066746 ↗InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN ENDURANT II STENT GRAFT LIMB WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A LARGE PSEUDOANEURYSM . IT WAS REPORTED THAT FEW DAYS POST INDEX PROCEDURE, THE PATIENT SUFFERED FROM A LIMB OCCLUSION AND BECAME SYMPTOMATIC. APPROXIMATELY ONE WEEK POST INDEX PROCEDURE, A FEM-FEM BYPASS WAS THEN PERFORMED. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS PATIENT'S ANATOMY DUE TO A DISEASED EXTERNAL ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Obstruction/Occlusion
MAUDE report 12473685 ↗MalfunctionJul 14, 2021Defective Component; Device Markings/Labelling Problem; Defective Component; Device Markings/Labelling Problem
AN ENDURANT II STENT GRAFT SYSTEM WAS ATTEMPTED TO BE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, A CALIBRATED PIGTAIL MARKER CATHETER WAS PLACED AT THE FLOW DIVIDER. HYPOGASTRIC TAKEOFF WAS MARKED WITH A RETROGRADE HAND INJECTION AND 9 CENTIMETERS WAS COUNTED AND A 16X10X93 WAS SELECTED. THE DEVICE WAS THEN INSERTED TO THE FLOW DIVIDER, BUT THE DEVICE WAS NOT DEPLOYED AS IT APPEARED TO BE 3 CENTIMETERS SHORT BASED ON THE GRAFT MARKERS. THE DEVICE WAS THEN REMOVED AND REPLACED BY A 124 LENGTH DEVICE, WHICH INITIALLY APPEARED LONG BUT FORESHORTENED APPROXIMATELY 1 CENTIMETERS AS USUALLY OCCURS. THE 124 LENGTH LIMB WAS SUCCESSFULLY DEPLOYED. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS THAT THE DEVICE APPEARED TO BE LABELED INCORRECTLY (SHORTER THAN EXPECTED). NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12166082 ↗InjuryDec 12, 2019Malposition of Device; Malposition of Device
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ULCER OF UNKNOWN SIZE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE IPSILATERAL GATE OF THE BIFURCATE WAS CANNULATED INSTEAD OF THE CONTRALATERAL GATE. AS A RESULT, BOTH STENT GRAFT LIMBS WERE IMPLANTED IN THE SAME GATE. THE SPIN TEST (CONFIRMED SPINNING THE MARKING CATHETER) WAS PERFORMED AND CLEARLY VISUALIZED. THE PHYSICIAN THEN IMPLANTED AN ENDURANT AUI DEVICE TO SEAL THE BIFURCATE AS TREATMENT AND COMPLETED A FEM-FEM BYPASS. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS A PROCEDURAL STEP ERROR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Injury
MAUDE report 9459047 ↗InjuryNov 14, 2018Leak/Splash; Leak/Splash
A TALENT AAA STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY TEN YEARS LATER THE PATIENT PRESENTED EMERGENTLY WITH BACK PAIN AND A CT SCAN PERFORMED IDENTIFIED CONTRAST IN THE ANEURYSM SAC WITH BILATERAL TYPE IB ENDOLEAKS OBSERVED. INTERVENTION WAS COMPLETED AT THIS TIME. ON THE RIGHT SIDE THE HYPOGASTRIC ARTERY WAS COILED AND A LIMB EXTENSION WAS PLACED LANDING ON THE EXTERNAL ILIAC (B)(4). AFTER BALLOONING THIS AREA WITH A RELIANT BALLOON IT APPEARED THERE WAS A TYPE III ENDOLEAK IMMEDIATELY PROXIMAL TO THIS PLACED DEVICE SO THE RIGHT ILIAC WAS RELINED WITH AN ADDITIONAL ENDURANT LIMB (B)(4). ON THE LEFT SIDE, AN ILIAC EXTENSION WAS IMPLANTED AT THE LEFT HYPOGASTRIC AND THE EVENT RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO BILATERAL ILIAC DILATION AFFECTING SEAL OF BOTH ILIAC LIMBS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.
Patient problems: Injury
MAUDE report 8068533 ↗InjuryOct 1, 2018Adverse 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 60MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING FOLLOW UP, OVER TWO YEARS LATER, A CT IDENTIFIED ANEURYSM ENLARGEMENT (FROM 50MM TO 60MM) WITHOUT AN ENDOLEAK. IT WAS REPORTED THAT THE PHYSICIAN PERFORMED OPEN REPAIR ON THE PATIENT AND EXPLANTED THE STENT GRAFTS. PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Aneurysm; Injury
MAUDE report 7922304 ↗InjuryMar 27, 2018Occlusion Within Device; Occlusion Within Device
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 56MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT 3 HOURS AFTER THE INDEX PROCEDURE THE PATIENT DID NOT HAVE A PULSE IN THEIR LEFT LEG AND WAS TAKEN BACK TO THEATRE. ANGIOGRAM CONFIRMED THAT THERE WAS NO FLOW IN THE LEFT SIDE AND THAT THE LEFT LIMB OF THE STENT GRAFT HAD THROMBOSED AND OCCLUDED. THE PATIENT RECEIVED A FEMORAL-FEMORAL BYPASS ON THE SAME DATE AND THE EVENT WAS RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO ANATOMY AND RELATED TO A KINK IN THE DISTAL PART OF THE LIMB DUE TO VESSEL TORTUOSITY AND CALCIFICATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Occlusion
MAUDE report 7372725 ↗InjuryOct 10, 2017Occlusion Within Device; Occlusion Within Device
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 57MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE INFRARENAL NECK WAS 22-25MM IN DIAMETER AND 28MM IN LENGTH WITH 19.3 ANGULATION. THERE WAS MILD TORTUOSITY IN THE LIMB. THE PATIENT HAD ATHERECTOMY AND COMMON FEMORAL ENDARTERECTOMY JUST PRIOR TO INDEX STENT GRAFT PROCEDURE. IT WAS REPORTED THAT THE PATIENT PRESENTED IN ER WITH LEG PAIN AND COLD LEG. IT WAS ALSO NOTED THAT THE PATIENT¿S LEG PAIN STARTED IN MID-THIGH AND FOOT OF THE RIGHT LEG 3 DAYS PRIOR. THROMBOLYSIS WAS PERFORMED AND FLOW WAS RESTORED. PER THE PHYSICIAN THE LIMB OCCLUSION WAS RESULT OF OUTFLOW ISSUES IN SFA AND CFA AND THE LIMB LOOKED FULLY DILATED AND PROPERLY SIZED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Occlusion; Pain
MAUDE report 6933730 ↗InjurySep 25, 2017Occlusion Within Device; Occlusion Within Device
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH LEG PAIN AND A SPIKED CREATININE LEVEL. A CT SCAN WAS PREFORMED AND REVEALED THAT THE LEFT ENDURANT ILIAC LIMB AND LEFT EXTERNAL ILIAC ARTERY WERE OCCLUDED, DUE TO TORTUOUS ANATOMY. THE PHYSICIAN PERFORMED A THROMBECTOMY WITH THE USE OF AN ANGIOJET MACHINE AND THE EKOS MACHINE TO DISSOLVE THE CLOT. AFTER THE ILIAC LIMB WAS PATENT A 10X 40 BARE METAL STENT WAS IMPLANTED IN THE DISTAL END OF THE ENDURANT STENT GRAFT. PER THE PHYSICIAN, THE CAUSE OF THE OCCLUSION WAS RELATED TO THE PATIENT¿S ANATOMY, THE DISTAL END OF THE ENDURANT STENT GRAFT WAS IMPLANTED NEAR A KINK OF THE PATIENT¿S NATIVE EXTERNAL ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Occlusion; Pain
MAUDE report 6890316 ↗InjuryJul 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN ENDURANT AUI STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 53X52MM DIAMETER ABDOMINAL AORTIC ANEURYSM UTILIZING A SENTRANT SHEATH. THE PROXIMAL LEFT EXTERNAL ILIAC ARTERY WAS 6MM IN DIAMETER. THE PROXIMAL AORTIC NECK MEASURED 29 MM TO 31 MM IN DIAMETER ALONG A 10 MM LENGTH. IT WAS REPORTED THAT THE RIGHT COMMON FEMORAL ARTERY WAS EXPOSED AND CONTROLLED WITH VESSEL LOOPS. THE ARTERY WAS ACCESSED WITH AN 18G NEEDLE AND WIRES AND CATHETERS WERE USED TO GAIN ACCESS INTO THE AORTA. THE PHYSICIAN PLACED A 20FR SHEATH OVER A LUNDERQUIST WIRE INTO THE INFRARENAL AORTA. ONCE THE SHEATH WAS IN PLACE THE ENDURANT AUI WAS PREPPED. THE PHYSICIAN ACCESSED THE SHEATH WITH A WIRE AND PIG TAIL CATHETER. AN AORTOGRAM WAS PERFORMED AND THE RENAL ARTERIES WERE IDENTIFIED. THE PIG TAIL CATHETER WAS REMOVED AND REPLACED WITH THE AUI. THE AUI WAS PLACED WAS BELOW THE RENAL ARTERIES WITH NO ISSUES. THE 20FR SHEATH WAS PULLED DISTAL TO THE HYPOGASTRIC AND AN ANGIOGRAM DONE TO MARK THE LOCATION OF THE LEFT COMMON ILIAC ARTERY. AN ENDURANT LIMB WAS PLACED IN PROPER POSITION. THE AUI AND LIMB WERE BALLOONED WITH A RELIANT WITH NO ISSUE. AT THIS TIME THE PATIENT STARTED H
Patient problems: Perforation of Vessels
MAUDE report 6704401 ↗InjuryMar 1, 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 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 6370610 ↗
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-0291-2022 · Oct 15, 2021 · Open, ClassifiedEndurant 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, 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
- 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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