Endurant IIsRecalls & reported problems across all models

We found 9 models of Endurant IIs by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 843 adverse event reports in the FDA's MAUDE database, received between Dec 1, 2016 and Sep 24, 2026 — classified as 120 deaths, 547 injuries, 176 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (472 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Endurant IIs recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 5 of these models · Recall details · FDA record ↗

2. Oct 15, 2021Open, Classified

   Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.

   Z-0292-2022 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗

3. Jun 7, 2021Open, Classified

   During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.

   Z-2136-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Endurant IIs problems

Endurant IIs models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Endurant® IIs ESBF2814C103E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 recalls34 deaths254 reports
• Endurant® IIs ESBF3214C103E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 recalls19 deaths173 reports
• Endurant® IIs ESBF3614C103E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall37 deaths214 reports
• Endurant® IIs ESBF2514C103E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 recalls18 deaths136 reports
• Endurant® IIs ESBF2314C103E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 recalls9 deaths60 reports
• Endurant® IIs ESBF3214C103E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths2 reports
• Endurant® IIs ESBF3614C103E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death2 reports
• Endurant® IIs ESBF2314C103E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• Endurant® IIs ESBF2814C103E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report

Recent Endurant IIs adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Leak/Splash; Material Deformation

  An Endurant IIs bifurcated stent graft system was implanted during the treatment of a 77mm abdominal aortic aneurysm. It was reported approximately 1 month post the index procedure, CT imaging identified a type Ia endoleak and stent graft infolding midway through the main body. Per the physician the cause of the event was undetermined and the event is unresolved. No additional clinical sequelae were reported and the patient is fine.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881829 ↗
• InjuryAug 31, 2026Leak/Splash

  It was reported that a patient with a rapidly growing 6 mm abdominal aortic aneurysm was treated with an Endurant IIs stent graft system for a short-neck indication. The physician believed the aneurysm may have represented a contained rupture; however, pre-operative aneurysm rupture was reported as absent. A residual type 1a endoleak was identified during the index procedure following treatment. A 28 mm Endurant cuff was used to treat the residual type 1a endoleak. During the  procedure,  Endurant cuff outer box was found to be damaged; however,  the inner sterile packaging was not compromised, and the graft was use to successfully treat the patient and seal the type 1a leak. The damage to the box was considerd to be due to handling during shipping. It was reported that the main body did not seal the proximal edge of the renal artery ostium.

  Patient problems: Insufficient Information

  MAUDE report 50516760 ↗
• MalfunctionAug 25, 2026Material Deformation

  It was reported that during the index procedure to treat a 55 mm abdominal aortic aneurysm, an Endurant IIs stent graft delivery system kinked at the mid-shaft during implantation. The aortic diameter at the renal artery was 27 mm, the proximal aortic neck length was 35 mm, and the neck had 10 degrees of angulation. The iliac anatomy was calcific and tortuous, and force was required to deliver the system. The physician was not comfortable continuing to use the kinked delivery system. The original device was not implanted, and was replaced with a new device. The replacement device was delivered without difficulty using a non-Medtronic 20 Fr sheath. Theevent was resolved. The Endurant IIs was prepared and used in accordance with the instructions for use (IFU), and no damage was noted to the device prior to insertion into the patient. According to the physician, the cause of the event was anatomy-related due to calcific and tortuous vessels. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50426220 ↗
• MalfunctionAug 24, 2026Difficult to Remove; Material Deformation

  An Endurant IIs stent graft (b)(6) was implanted during the endovascular treatment of a 58.5 mm abdominal aortic aneurysm. It was reported that during the index procedure, after visual inspection prior to use, the stent graft was delivered through the left common femoral artery to the implantation site. During deployment of the device, the physician applied gentle backward force pulling, rather than advancing, to keep the radiopaque markers aligned with the renal artery lines drawn on the screen. No resistance was felt by the physician. The device was delivered easily into position and implanted successfully. During removal of the delivery system, which was performed in accordance with the instructions for use (IFU), difficulty was encountered while attempting to remarry the delivery system , as the grey handle would not slide fully to the blue handle after advancing approximately halfway. Manual rotation of the blue handle was required to bring it into contact with the grey handle. Following removal, inspection identified a large twist or kink in the distal portion of the graft cover portion of the delivery device. The delivery device was successfully removed from the left groin,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50404789 ↗
• InjuryAug 7, 2026Leak/Splash; Malposition of Device

  An Endurant IIs stent graft system was implanted during the endovascular treatment of a 71mm abdominal aortic aneurysm. It was reported that during the index procedure, EVAR was performed and, upon completion angiography, the device was found not to have been delivered to the intended location. The proximal edge of the graft was positioned approximately 6 mm distal to the left renal artery, and a Type Ia endoleak was identified. An aortic extension ETCF2828C49E was placed in desired proximal position with no endoleak observed. Per the physician the cause is undetermined. No additional clinical sequelae were reported and the patient is fine.

  Patient problems: Insufficient Information

  MAUDE report 50173737 ↗
• MalfunctionMay 19, 2026Leak/Splash

  IT WAS REPORTED THAT A TYPE IA ENDOLEAK ASSOCIATED WITH AN ESBF2814C103E STENT GRAFT WAS IDENTIFIED ON A CT TAKEN ON AN UNKNOWN DATE. THE PHYSICIAN PLANS TO IMPLANT A CUFF EXTENDING TO THE RENAL ARTERIES; HOWEVER, THE PROCEDURE HAS NOT YET BEEN SCHEDULED. THE END OLEAK IS BELIEVED TO BE DUE TO DISEASE PROGRESSION. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221330 ↗
• MalfunctionMay 19, 2026Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 11 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT IDENTIFIED A TYPE IA AND POSSIBLE BILATERAL TYPE IB ENDOLEAKS. THE PHYSICIAN ELECTED TO TRANSFER THE PATIENT TO A DIFFERENT FACILITY FOR POSSIBLE FURTHER INTERVENTION. THE CAUSE OF THE ENDOLEAKS ARE UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216629 ↗
• InjuryMay 18, 2026Leak/Splash

  IT WAS REPORTED THAT AN ENDURANT II/IIS BIFURCATED STENT GRAFT WAS USED DURING AN ENDOVASCULAR AORTIC REPAIR FOR A 40 MM SACCULAR ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE GRAFT WAS DEPLOYED WITHOUT ISSUES. THE GRAFT WAS THEN BALLOONED WITH A RELIANT, AND A POST-DEPLOYMENT ANGIOGRAM SHOWED A TYPE IV ENDOLEAK WITH EXTRAVASATION INTO WHAT APPEARED TO BE A RUPTURE DISTAL TO THE FLOW DIVIDER (ACTIVATED CLOTTING TIME OF 374). ADDITIONAL ENDOVASCULAR TREATMENT WAS PERFORMED WITH TWO NON MDT 9 MM X 39 MM STENTS PLACED HALF ABOVE AND HALF BELOW THE FLOW DIVIDER, FOLLOWED BY ADDITIONAL BALLOONING USING TWO 12 MM X 4 CM BALLOONS IN A KISSING TECHNIQUE. A POST-INTERVENTION ANGIOGRAM CONFIRMED RESOLUTION OF THE TYPE INTRAVENOUS ENDOLEAK AND EXTRAVASATION. THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION AND WAS REPORTED TO BE ALIVE WITH NO INJURY. THE PHYSICIAN ATTRIBUTED THE EVENT TO ANATOMY, STATING THE PATIENT HAD A NARROW DISTAL AORTA AND A SHELF INDENTATION BENEATH THE ANEURYSM THAT MAY HAVE RUPTURED DURING GRAFT BALLOONING.

  Patient problems: Rupture

  MAUDE report 25199766 ↗
• InjuryMay 1, 2026Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 1 MONTH POST THE INDEX PROCEDURE, FOLLOW UP CT SHOWED WHAT APPEARS TO BE SOME CONTRAST IN AAA SAC AND IS SUSPECTED TO BE A TYPE IA ENDOLEAK. INTERVENTION AND ANGIOS ARE PLANNED. PER THE PHYSICIAN THE CAUSE IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25055391 ↗
• MalfunctionApr 29, 2026Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED AS A PART OF A POST-MARKET CLINICAL STUDY. IT WAS REPORTED THAT A TYPE IA ENDOLEAK ENDOLEAK WAS IDENTIFIED ON THE SAME DATE OF THE INDEX PROCEDURE. NO INTERVENTION HAS BEEN PERFORMED. NO CAUSE WAS PROVIDED. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25026634 ↗
• MalfunctionApr 29, 2026Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT SHOWED A TYPE IA ENDOLEAK IN THE NECK OF THE GRAFT. INTERVENTION IS PLANNED TO BE COMPLETED. PER THE PHYSICIAN, THE CAUSE OF THE ENDOLEAK IS UNCERTAIN, BUT MAY BE RELATED TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25025663 ↗
• MalfunctionApr 27, 2026Material Deformation

  AN ESBF3214C103E STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK DIAMETER MEASURED 28 MM. IT WAS REPORTED THAT AFTER DEPLOYMENT OF ALL STENT GRAFT COMPONENTS, INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED THROUGH THE GRAFT TO CONFIRM THE ABSENCE OF OCCLUSIONS. WHILE ADVANCING THROUGH THE LEFT ILIAC LIMB AND THE TOP OF THE GATE NEAR THE FLOW DIVIDER, A KINK CONSISTENT WITH STENT GRAFT INFOLDING WAS OBSERVED. TOUCH-UP WITH A RELIANT BALLOON WAS ATTEMPTED USING SUSTAINED INFLATION; HOWEVER, FOLLOW-UP IVUS DEMONSTRATED MINIMAL CHANGE, DESPITE MULTIPLE INFLATIONS. BILATERAL 16MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOONS WERE THEN USED IN AN ATTEMPT TO CORRECT THE ISSUE. SUBSEQUENT IVUS ASSESSMENT SHOWED IMPROVEMENT, ALTHOUGH A SMALL INFOLD REMAINED. NO VISIBLE REDUCTION IN BLOOD FLOW WAS OBSERVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY-RELATED. A BEND IN THE PROXIMAL NECK WAS PRESENT AND THE INFOLDING WAS OBSERVED AT THE POINT WHERE THE ANATOMY TAPERED DOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24996869 ↗
• InjuryApr 15, 2026Device Damaged by Another Device; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INDEX ENDOVASCULAR PROCEDURE TO TREAT A 45 MM ABDOMINAL AORTIC ANEURYSM, AN ENDURANT II/IIS STENT GRAFT SYSTEM (ESBF3214C103E WITH ETLW1616C93E AND ETLW1620C93E) WAS IMPLANTED SUCCESSFULLY AND ENDO-ANCHORS WERE THEN DEPLOYED. FIVE ENDO-ANCHORS WERE IMPLANTED SUCCESSFULLY; HOWEVER, DURING DEPLOYMENT OF THE SIXTH ENDO-ANCHOR, THE ANCHOR WAS REPORTED TO NOT BE ENGAGED WITH THE GRAFT FABRIC OR ARTERIAL WALL WHEN DEPLOYED. THE ENDO-ANCHOR MIGRATED ABOVE THE SUPRARENAL STENTS OF ESBF3214C103E. THE PHYSICIAN REMOVED THE ENDO-ANCHOR DELIVERY SYSTEM, INSERTED THE DILATOR OF A 16 FR SHEATH, AND ADVANCED THE 16 FR SHEATH PROXIMAL TO THE SUPRARENAL STENTS OF ESBF3214C103E OVER A STIFF 0.035-INCH GUIDEWIRE, THEN REMOVED THE DILATOR. A GOOSE-NECK STYLE SNARE WAS INSERTED TO ATTEMPT TO SNARE THE UNFIXED ENDO-ANCHOR. DURING THIS MANEUVER THE 16 FR SHEATH AND SNARE WERE PULLED DOWN INTO THE GRAFT, AFTER WHICH THE SNARE BECAME TANGLED WITH THE SUPRARENAL STENTS OF ESBF3214C103E. THE PHYSICIAN ATTEMPTED UNSUCCESSFULLY TO FREE THE SNARE AND THEN CONVERTED TO AN OPEN SURGICAL REPAIR OF THE ABDOMINAL ANEURYSM. THE ESBF3214C103E, ETLW1616C93E, ETLW1620C93E, AND SA-85 ENDO-A

  Patient problems: Insufficient Information

  MAUDE report 24881295 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN AAA IT WAS REPORTED THAT APPROXIMATELY 2 YEARS AND 1 MONTH LATER , THE PATIENT WAS DIAGNOSED WITH A CHRONIC KIDNEY DISEASE. THE PATIENT'S EGRF LEVELS DECLINED GREATER THAN 20 PERCENT COMPARED TO THE VALUE AT THE TIME OF IMPLANT TWO YEARS AGO. THE SITE ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DEVICE, INDEX PROCEDURE AND AN UNDERLYING CONDITION AND OR DISEASE.

  Patient problems: Renal Failure

  MAUDE report 24869222 ↗
• InjuryMar 26, 2026Malposition of Device

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR AORTIC REPAIR OF A 77 MILLIMETER ABDOMINAL AORTIC ANEURYSM, AFTER STANDARD EVAR WAS COMPLETED ON FINAL ANGIOGRAM THE PHYSICIAN WAS CONCERNED THAT THE GRAFT LANDED 5 MILLIMETERS BELOW THE RENAL ARTERIES (20MM NECK LENGTH). NO ENDOLEAK WAS OBSERVED. THE PHYSICIAN ELECTED TO IMPLANT A 28X49 ENDURANT II CUFF.  AFTER DEPLOYING THE ENTIRE CUFF BUT BEFORE RELEASE OF THE BARE SPRINGS THE PHYSICIAN WAS CONCERNED ABOUT BEING TOO HIGH ON THE RENALS. NEGATIVE PRESSURE ON THE DELIVERY SYSTEM WAS APPLIED WHILE ROTATING THE SMALL BLUE KNOB TO RELEASE THE BARE SPRINGS. THE BLUE KNOB WAS TURNED UNTIL IT COULD NOT TURN ANY FURTHER BUT DID NOT RELEASE AS INTENDED, LEAVING 3 MILLIMETERS OF BARE SPRINGS IN THE NOSE CONE. SLIGHT FORWARD PRESSURE ON THE DEVICE AND A WRIGGLING MOVEMENT WAS ATTEMPTED BUT THE BARE SPRINGS DID NOT RELEASE.  BAIL OUT TECHNIQUES WERE EMPLOYED AND THE BACK END WH EEL REMOVED TO TRY AND SLIDE CLEAR THE TABS FORWARD TO MANUALLY PUSH UP THE NOSE CONE TO RELEASE THE SPRINGS BUT THIS DID NOT WORK. A RELIANT BALLOON WAS INSERTED VIA THE CONTRA SIDE UP AGAINST THE NOSE CONE AND INFLATED. IT EFFECTIVELY RELEASED THE SPRINGS/HOOKS FROM THE NOS

  Patient problems: Insufficient Information

  MAUDE report 24696176 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls