Endurant® II ETBF2516C166ERecalls & reported problems
Medtronic, Inc. · STENT GRAFT ETBF2516C166E ENDUR II BIF · Class 3 · Implant
All models of Endurant II (114)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00613994991270), received between Mar 9, 2017 and Feb 23, 2023 — classified as 11 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (13 reports).
2 FDA recall records name this device's identifier, 1 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 16, 2026.
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 ↗
- Feb 27, 2017Class IITerminated
Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific models and serial numbers as this specific subset of stent grafts has greater susceptibility to fabric permeability variations that may be associated with endoleaks observed during the initial implant procedure.
Z-1543-2017 · Root cause: Packaging change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Leak/Splash13
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Difficult to Remove1
- Migration or Expulsion of Device1
- Occlusion Within Device1
- Patient-Device Incompatibility1
Patient problems
- Injury7
- No Consequences Or Impact To Patient6
- Pain2
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Obstruction/Occlusion1
- Occlusion1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjuryFeb 23, 2023Leak/Splash; Leak/Splash
AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA. IT WAS REPORTED A CTA WAS PERFORMED APPROXIMATELY 9 YEARS POST THE INDEX PROCEDURE. THE CTA SHOWED DISEASE PROGRESSION WITH A LOSS OF SEAL PROXIMALLY AND A POSSIBLE LOSS OF SEAL DISTALLY ALSO. THE PATIENT ALSO HAS A RETROPERITONEAL HEMATOMA WHICH IS UNRELATED TO THE ANEURYSM. REVIEW OF THE IMAGING ALSO NOTED A POSSIBLE RUPTURE/INFECTION OF THE ANEURYSM SAC. AN ANGIOGRAM WAS SUBSEQUENTLY PERFORMED WHICH REVEALED A TYPE IA AND TYPE IB ENDOLEAK. INTERVENTION WAS COMPLETED WHERE THE STENT GRAFTS WERE EXPLANTED. THE PATIENT WAS REPORTED AS DOING WELL POST THE INTERVENTION. IT WAS CONFIRMED THAT THE BLOOD OBSERVED IN THE RETROPERITONEAL CAVITY WAS A RESULT OF THE PATIENT FALLING. IT WAS CONFIRMED THAT THERE WAS NO GRAFT INFECTION OR ANEURYSM RUPTURE. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK WAS DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.
Patient problems: Insufficient Information
MAUDE report 16425772 ↗MalfunctionDec 7, 2022Difficult to Remove; Difficult to Remove
AN ENDURANT II BIFURCATE STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 55MM AAA . IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE GUIDEWIRE GOT STUCK INSIDE THE DELIVERY SYSTEM. THE GUIDEWIRE AND DELIVERY SYSTEM HAD TO BE REMOVED TOGETHER AS THE WIRE WOULD NOT COME OUT OF THE DELIVERY SYSTEM. THIS DID NOT CAUSE AN ISSUE FOR THE PROCEDURE. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15932140 ↗InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 53 MM ABDOMINAL AORTIC ANEURYSM. A CT WAS PERFORMED 10 MONTHS LATER, WHERE A LIMB OCCLUSION WAS NOTED. THROMBECTOMY AND RE-LINING OF RIGHT SIDE LIMB WITH STENTS WAS PERFORMED TO RE-ESTABLISH PATENCY OF THE OCCLUDED LIMB. IT WAS REPORTED THAT IT WAS THE MAIN BODY BIFURCATE THAT WAS OCCLUDED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus
MAUDE report 11989769 ↗InjuryNov 19, 2019Leak/Splash; Leak/Splash
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 65MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED TO HOSPITAL SYMPTOMATIC BUT STABLE. ULTRASOUND IDENTIFIED A TYPE III ENDOLEAK NEAR THE BODY OF THE GRAFT. DUE TO COILS PREVIOUSLY PLACED IN THE ANEURYSM SAC, THE CT SCAN WAS NOT AS DEFINITIVE FOR ENDOLEAK DETERMINATION. AN ANGIOGRAM WAS COMPLETED CONFIRMING A TYPE III ENDOLEAK ABOVE THE FLOW DIVIDER IN THE MAIN BODY OF THE GRAFT. ENDOANCHORS WERE PLACED IN THE ORIGINAL GRAFT TO FIXATE IT TO THE WALL AND ALSO PROPHYLACTICALLY FOR A TYPE IA IF IT WAS THERE, BUT NOT EVIDENT. AN ENDURANT AUI WAS THEN IMPLANTED (ETUF2814C102E) AT THE LEVEL OF THE RENALS AND EXTENDED TO THE LEFT HYPOGASTRIC WITH A (ETLW1620C124E) GAINING A CENTIMETER OF SEAL ON THE LEFT WITH THE ADDITIONAL LIMB. THE RIGHT LIMB WAS EMBOLIZED AND A FEM-FEM BYPASS WAS DONE. PER THE PHYSICIAN THE CAUSE OF THE TYPE III ENDOLEAK WAS DUE TO UNDERSIZING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Injury
MAUDE report 9341331 ↗InjuryJul 24, 2019Leak/Splash; Leak/Splash
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 52MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT CT APPROXIMATELY THREE YEARS LATER SHOWED THAT THE PATIENT¿S ANEURYSM HAD GROWN FROM 52MM PRE THE INDEX PROCEDURE TO OVER 60MM. NO OBVIOUS ENDOLEAK WAS OBSERVED FROM THE IMAGES. ANGIOGRAPHY WAS CARRIED OUT ON THE PATIENT TWO WEEKS LATER INCLUDING AN AORTOGRAM, SELECTIVE BILATERAL INTERNAL ILIAC'S AND BILATERAL ILIAC INJECTIONS. THE PHYSICIAN COULD NOT IDENTIFY A TYPE II OR TYPE IB ENDOLEAK. THE AORTOGRAM DID HOWEVER SHOW AN AREA SUSPICIOUS FOR A TYPE IA ENDOLEAK, SO IT WAS DECIDED TO PLACE 7 ENDOANCHORS TO RESOLVE THIS. AS PER THE PHYSICIAN, THERE IS NO KNOWN CAUSE OF THE TYPE IA ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Injury
MAUDE report 8821724 ↗MalfunctionOct 8, 2018Leak/Splash; Leak/Splash
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 90MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON 4 YEAR FOLLOW UP CT, A TYPE IA ENDOLEAK WAS IDENTIFIED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS ANATOMY RELATED, DUE TO DISEASE PROGRESSION IN THE AORTIC NECK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7941990 ↗MalfunctionAug 21, 2018Leak/Splash; Leak/Splash
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 51MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT WAS PRESENTED EMERGENTLY APPROX. 1-YEAR POST INDEX PROCEDURE. A CT SCAN REVEALED A TYPE IA ENDOLEAK. PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7801505 ↗MalfunctionAug 3, 2018Leak/Splash; Patient-Device Incompatibility; Leak/Splash
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 63MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE A TYPE IA ENDOLEAK WAS DETECTED. THE PATIENT HAD A SHORT 5MM NECK WITH POSTERIOR BULGE DISTAL TO 5MM NECK. A TOTAL OF 10 ENDOANCHORS WERE PLACED AS PART OF THE PLANNED PROCEDURE DUE TO THE SHORT PROXIMAL NECK BUT THE TYPE IA ENDOLEAK PERSISTED. THE POSTERIOR BULGE FILLED WITH CONTRAST ABRUPTLY DURING ANGIOGRAM BUT ONLYA SMALL LEAK OF CONTRAST WENT INTO THE AAA. CT THE FOLLOWING DAY SHOWED A MINIMAL TYPE IA ENDOLEAK ENTERING THE SAC AND A LARGER TYPE II ENDOLEAK. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS DUE TO PATIENTS¿ ANATOMY WITH SHORT NECK WITH POSTERIOR BULGE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Consequences Or Impact To Patient
MAUDE report 7746058 ↗MalfunctionApr 18, 2018Leak/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 WHEN THE PATIENT HAD A CT SCAN FOR ANOTHER REASON THE PHYSICIAN OBSERVED A TYPE IA ENDOLEAK. THE PHYSICIAN ATTRIBUTED THE CAUSE OF THE ENDOLEAK TO DISEASE PROGRESSION ADVANCING UP THE NECK. THE PHYSICIAN ALSO OBSERVED THAT THE GRAFT HAD LANDED LOW ON THE ORIGINAL IMPLANT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7439249 ↗InjuryFeb 13, 2018Leak/Splash; Leak/Splash
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 59MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PATIENTS PROXIMAL AORTIC NECK DIAMETER RANGED FROM 21-22MM AND WAS 10MM IN LENGTH. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE DEVICE WAS IMPLANTED AS PLANNED, LANDING DISTAL TO THE RIGHT RENAL ARTERY AND THE PROCEDURE WAS COMPLETED AS PLANNED. IT WAS NOTED THAT THE FINAL ANGIOGRAM SHOWED A TYPE IA ENDOLEAK AND SO EIGHT ENDOANCHORS WERE PLACED IN AN EFFORT TO SEAL THE ENDOLEAK. IT WAS NOTED THAT THIS PROVED INEFFECTIVE IN COMPLETE RESOLUTION OF THE LEAK. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS ANATOMY RELATED DUE TO A SHORT AND ANGLED PROXIMAL SEAL ZONE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.
Patient problems: Injury
MAUDE report 7266309 ↗InjuryJan 26, 2018Leak/Splash; Leak/Splash
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE TREATMENT OF A 9.0CM ABDOMINAL AORTIC ANEURYSM ON. IT WAS REPORTED THAT DURING A FOLLOW UP EXAMINATION PERFORMED APPROXIMATELY 3.5 YEARS POST INDEX PROCEDURE, AN ENDOLEAK WAS OBSERVED. IT WAS REPORTED THAT THE PATIENT RECEIVED TREATMENT WITH THE IMPLANT OF AN AORTIC CUFF AND A LIMB EXTENSION. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Injury
MAUDE report 7220995 ↗InjuryJan 10, 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 4.6CM ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 19MM PROXIMALLY AND 23 MM IN DIAMETER DISTALLY WITH 20 DEGREE OF CRANIAL ANGULATION. IT WAS REPORTED THE PATIENT RETURNED FOR FOLLOW-UP CT APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE. A TYPE IA ENDOLEAK AND MIGRATION OF THE BIFUR 10MM BELOW RENALS WAS OBSERVED. THE DEVICE HAD BEEN PREVIOUSLY CONFIRMED AS DEPLOYED AT THE TARGET LOCATION IN THE ONE MONTH FOLLOW UP CT POST THE INDEX PROCEDURE. THE PHYSICIAN HAS ELECTED TO PERFORM SECONDARY INTERVENTION. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.
Patient problems: Injury; No Consequences Or Impact To Patient
MAUDE report 7177745 ↗InjuryJul 27, 2017Leak/Splash; Leak/Splash
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 PATIENT RETURNED FOR FOLLOW UP. ON AN UNKNOWN DATE THE CT REVEALED A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT HELI-FX APTUS ENDOANCHORS AND THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE PROXIMAL TYPE I ENDOLEAK WAS RELATED TO THE PATIENT¿S ANATOMY OF DISEASE PROGRESSION AND AORTIC NECK ANGULATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Injury
MAUDE report 6749393 ↗InjuryJul 21, 2017Leak/Splash; Leak/Splash
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A FOLLOW-UP NON CONTRAST CT SHOWED AN ENLARGING RIGHT COMMON ILIAC ARTERY ANEURYSM. THE PHYSICIAN DID AN ANGIOGRAM ON THE SAME DAY AND FOUND THAT THERE WAS A DISUNION BETWEEN THE MAIN BODY GRAFT AND THE LIMB EXTENSION. THERE IS AN ENDOLEAK ON ANGIO. AN ENDURANT ILIAC STENT GRAFT WAS IMPLANTED. THE PHYSICIAN STATED THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.
Patient problems: Injury
MAUDE report 6734078 ↗InjuryJul 5, 2017Occlusion Within Device; Occlusion Within 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 PATIENT PRESENTED EMERGENTLY WITH LEG PAIN. A CT SCAN REVEALED THAT THERE WAS A RIGHT LIMB OCCLUSION AND THE LIMB HAD NARROWED AT THE LEVEL OF THE AORTIC BIFURCATION. A PROCEDURE WAS PERFORMED TO CANNULATE AND DECLOT THE LIMB. THE PHYSICIAN WAS ABLE TO PASS A WIRE THROUGH THE OCCLUSION. THEY THEN USED A FOGERTY CATHETER TO PULL THE CLOT FROM THE LIMB. SEVERAL PASSES WERE MADE AND THE CLOT WAS SUCCESSFULLY REMOVED. THE RIGHT LIMB WAS THEN LINED WITH A 16X24X124 ENDURANT ILIAC LIMB AND BALLOONING WAS PERFORMED. THE PHYSICIAN THEN OPTED TO REINFORCE BOTH ILIAC LIMBS AT THE NATIVE BIFURCATION USING 2 BALLOON EXPANDABLE STENTS. AN ANGIOGRAM WAS PERFORMED AND SHOWED THAT BOTH LIMBS WERE PATENT AND THE PROCEDURE WAS COMPLETED. IT WAS NOTED THAT THE EVENT RESOLVED. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS DUE TO PATIENT ANATOMY; SPECIFICALLY, A TIGHT NATIVE DISTAL AORTIC NECK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Occlusion; Pain
MAUDE report 6688523 ↗InjuryJun 27, 2017Leak/Splash; Leak/Splash
AN ENDURANT II STENT GRAFT SYSTEM WAS SELECTED FOR USE IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH BACK AND ABDOMINAL PAIN. THE CT REVEALED THAT THERE WAS A TYPE III SEPARATION ENDOLEAK BETWEEN THE ENDURANT BIFURCATED STENT GRAFT AND THE ENDURANT 16X13X124. CURRENTLY THE ABDOMINAL AORTIC ANEURYSM IS 7.3 CM IN DIAMETER AND 9.3 CM IN LENGTH. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT 16X16X156 ILIAC LIMB. THE FINAL ANGIOGRAM DEMONSTRATED THAT THE TYPE III SEPARATION ENDOLEAK WAS RESOLVED. TWO DAYS LATER THE FOLLOW UP CT REVEALED THAT THERE WAS AN UNKNOWN ENDOLEAK IN THE AREA OF THE JUNCTION OF THE BIFURCATED STENT GRAFT AND THE ENDURANT 16X20X156 ILIAC LIMB ON THE OTHER SIDE. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT 16X20X124 ILIAC LIMB. THE UNKNOWN ENDOLEAK WAS RESOLVED. THE PHYSICIAN STATED THAT THE CAUSE OF BOTH, THE TYPE III SEPARATION ENDOLEAK AND THE UNKNOWN ENDOLEAK WERE RELATED TO THE PATIENT¿S ANATOMY; DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Pain
MAUDE report 6671733 ↗MalfunctionMar 9, 2017Break; Break
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.2 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE ENDURANT STENT GRAFT BODY DEPLOYED AND WHEN THE THUMB WHEEL WAS GOING TO BE TURNED TO RELEASE THE SUPRARENAL STRUTS THE BACK-END WAS BROKEN AND SEPARATED FROM THE REST OF THE DEPLOYMENT HANDLE. THE PHYSICIAN DECONSTRUCTED THE HANDLE AND MANUALLY DEPLOYED THE TIP CAPTURE RELEASE AND THE STENT GRAFT WAS SUCCESSFULLY DEPLOYED. THE PHYSICIAN CANNOT DETERMINE THE CAUSE OF THE EVENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6393122 ↗
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-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-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-0290-2022 · Oct 15, 2021 · Open, ClassifiedEndurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
- 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 aort
- 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 i
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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