Endurant® II ETLW1616C146ERecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000519957), received between Jul 28, 2022 and Jan 26, 2026 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (2 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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR AORTIC REPAIR PROCEDURE TO TREAT A 58 MM ABDOMINAL AORTIC ANEURYSM, AFTER DEPLOYMENT AND SUCCESSFUL REMOVAL OF THE STENT GRAFT ETLW1616C146E ENDUR II LIMB, ANESTHETICS NOTED A DROP IN BLOOD PRESSURE. ANGIOGRAPHY OF THE LEFT EXTERNAL ILIAC ARTERY REVEALED A RUPTURE, WITH BLEEDING AT THE RUPTURE SITE. THE PATIENT REQUIRED TAMPONADE OF THE BLEEDING SITE WITH AN 8MM X 4CM BALLOON. AFTER STABILIZATION OF BLOOD PRESSURE, TWO NON-MEDTRONIC(8MM X 59MM AND 8MM X 39MM) WERE PLACED TO SEAL THE INJURY. THE ANATOMY WAS NOTED TO BE TORTUOUS AND CALCIFIED AT THE LEFT EXTERNAL ILIAC , WHICH CONTRIBUTED TO THE EVENT. THE INJURY WAS RESOLVED AND THE REPAIR WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS STABLE IN THE INTENSIVE CARE UNIT AND WAS REPORTED TO BE RECOVERING WITH NO NEW ISSUES. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 24176332 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM (ESBF3214C103E, SN (B)(6); ETLW1616146E, SN (B)(6) AND ETLW1620C146E, SN (B)(6)) WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 47 MM ABDOMINAL AORTIC ANEURYSM (AAA). THE AAA WAS ASSOCIATED WITH TWO PSEUDOANEURYSMS ORIGINATING FROM THE ANEURYSM SAC, WHICH WERE CONSIDERED HIGH RISK FOR RUPTURE. APPROXIMATELY FOUR MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH A COLD, ISCHEMIC LEFT LEG. COMPUTED TOMOGRAPHY (CT) REVEALED OCCLUSION OF THE LEFT STENT GRAFT LIMB ETLW1616146E, AS WELL AS AN OCCLUDED INTERNAL ILIAC ARTERY AND CLOT IN THE LOWER LEG. THROMBUS WAS OBSERVED IN THE STENT GRAFT LIMB, EXTENDING FROM THE OVERLAP WITH THE MAIN BODY UP TO THE LEVEL OF THE FLOW DIVIDER. THE ENDURANT STENT GRAFT LIMB ETLW1620C146E ALSO IMPLANTED DURING THE INITIAL PROCEDURE WAS UNAFFECTED AND APPEARED WIDELY PATENT ON BOTH CT AND ANGIOGRAPHY. DUE TO SIGNS OF LIMB ISCHEMIA, THE PHYSICIAN PROCEEDED WITH URGENT SURGICAL INTERVENTION. A LEFT FEMORAL CUTDOWN WAS PERFORMED, FOLLOWED BY A BALLOON THROMBECTOMY, WHICH REMOVED MOST OF THE CLOT FROM THE LIMB, LEAVING A SMALL RESIDUAL AMOUNT. THE PHYSICIAN DECIDED TO RELINE THE LEF

  Patient problems: Ischemia; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 22608705 ↗
• MalfunctionJun 20, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A RUPTURED ABDOMINAL AORTIC ANEURYSM MEASURING 60 MILLIMETERS, THE MAIN BODY AND CO NTRALATERAL LIMB WERE SUCCESSFULLY DEPLOYED. UPON OPENING THE PACKAGING FOR THE IPSILATERAL LIMB, THE PACKAGING APPEARED UNDAMAGED. HOWEVER, ONCE THE DEVICE WAS REMOVED, IT WAS OBSERVED THAT THE DISTAL GREY COMPONENT¿ONTO WHICH THE BLUE HANDLE IS THREADED¿WAS BRO KEN, EXTENDING FROM THE DISTAL END TO THE THREADED SEGMENT. THE DEVICE WAS NOT INTRODUCED INTO THE PATIENT AND WAS DISCARDED. A REPLACEMENT STENT GRAFT WAS OPENED AND SUCCESSFULLY IMPLANTED WITHOUT FURTHER INCIDENT. THE PATIENT WAS TREATED WITH A 28 MM ENDURANT II STENT GRAFT AND BILATERAL 16X16 MM LIMBS. PER THE PHYSICIAN THE CAUSE OF THE BROKEN DEVICE WAS DUE AS DUE TO THE DEVICE BEING DAMAGED OUT OF THE BOX. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296268 ↗
• MalfunctionMay 15, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TWO ENDURANT LIMB STENT GRAFT ETLW1616C124E AND ETLW1616C146E WERE PLANNED TO BE IMPLANTED THAT DURING THE TREATMENT A 12.7 MM TYPE IB ENDOLEAK IN AN UNKNOWN PREVIOUS STENT GRAFT. THE DEPLOYMENT STEPS WERE FOLLOWED PER THE INSTRUCTIONS FOR USE. IT WAS NOTED THAT THE EXTERNAL SLIDER ROTATION FAILED TO DEPLOY THE STENT GRAFT, AND THE GRAFT COVER DID NOT RETRACT AS INTENDED. BASED ON FLUOROSCOPIC IMAGING, THE GRAFT COVER DID NOT RETRACT, THE NOSE CONE OF THE DEPLOYMENT SYSTEM ADVANCED FORWARD WITH THE GRAFT COVER STILL COMPLETELY COVERING THE STENT GRAFT. THE SAME ISSUE OCCURRED IN BOTH DEVICES. THE DEPLOYMENT ISSUE WAS ANATOMY RELATED DUE AN ATTEMPT TO DEPLOY THE DEVICE WITHIN AN ACUTELY ANGLED LIMB OF A PRE-EXISTING NON-MEDTRONIC ABDOMINAL ENDOGRAFT. AN ETLW1620C124E DEVICE WAS SUCCESSFULLY DEPLOYED IN THE DISTAL PORTION OF THE EXISTING LIMB WHERE THE LANDING WAS NOT AS ACUTELY ANGLED. THE ENDOLEAK APPEARED TO BE RESOLVED ACCORDING TO THE SURGEON AFTER THE FINAL ANGIOGRAM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22025661 ↗
• MalfunctionNov 18, 2024Difficult to Insert; Difficult to Insert

  AN ENDURANT II STENT GRAFT LIMB WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 79 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, AFTER FLUSHING THE GUIDEWIRE LUMEN WITHOUT ISSUE, THE PHYSICIAN ATTEMPTED TO LOAD THE ENDURANT STENT GRAFT ONTO A NON-MEDTRONIC 035" WIRE, BUT THE WIRE COULD NOT PASS THROUGH THE WIRE EXIT PORT, PREVENTING ADVANCEMENT OF THE DEVICE ON THE WIRE FURTHER. THE DELIVERY SYSTEM WAS ON THE WIRE ONLY ON THE OUTSIDE OF THE BODY. IT DID NOT EVEN TRAVEL FAR ENOUGH FOR THE TIP TO ENTER THE ACCESS. THE DEVICE WAS REMOVED, AND THE WIRE WAS WIPED AND INSPECTED FOR A KINK, NO KINKS WERE OBSERVED. A SECOND ATTEMPT TO LOAD THE DEVICE WAS MADE, THE WIRE STILL WOULD NOT PASS COMPLETELY THROUGH WIRE LUMEN, AND THE DEVICE COULD NOT BE ADVANCED. IT WAS CONFIRMED THAT THERE WAS NO DAMAGE NOTED TO THE DEVICE OR DEVICE PACKAGING PRIOR TO OPENING AND THE DEVICE WAS REMOVED FROM PACKAGING AS USUAL. THE ENDURANT STENT GRAFT WAS REPLACED WITH ANOTHER ENDURANT II STENT GRAFT LIMB (ETLW1616C124E) AND WAS SUCCESSFULLY DEPLOYED OVER THE SAME WIRE WITHOUT ANY ISSUES. THE WIRE WAS NOT EXCHANGED, AND THE SAME WIRE USED WHEN THE REPLACEMENT GRAF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20705911 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED AS PART OF THE ADVANCE STUDY FOR THE TREATMENT OF ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PATIENT REQUIRED A LEFT RENAL STENT DUE TO AN ENCROACHMENT OF THE ENDURANT IIS BIFURCATE ACCIDENTLY AND PARTIAL COVERAGE OF THE RENAL ARTERY. THE PATIENT HAD CONTINUED COMPLAINTS OF LEFT FLANK PAIN FOLLOWING THE PROCEDURE AND A CT THREE DAYS LATER SHOWED A HYPERENHANCEMENT OF THE KIDNEY INVOLVING THE MID PORTION AND LOWER POLE CONCERNING A LEFT RENAL INFRACT. IT WAS REPORTED 6 DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED RESPIRATORY DECOMPENSATION AND ALTERED MENTAL STATUS, REQUIRING INTUBATION AND TRANSFER TO ICU.  A BRONCHOALVEOLAR LAVAGE (BAL) WAS PERFORMED, REVEALING PROTEUS MIRABILIS. THE PATIENT REQUIRED V ASOPRESSORS UNDERWENT EXPLORATORY LAPAROTOMY DUE TO CONCERN OF ISCHEMIC BOWEL, HOWEVER, NO ISCHEMIA WAS NOTED. THE PATIENT REQUIRED PROLONGED HOSPITALIZATION AND UNDERWENT CHEST X-RAYS (CXR) AND CT IMAGING. THE PATIENT WAS TREATED FOR SEPTIC SHOCK WITH ANTIBIOTIC THERAPY. THE SITE ASSESSED THE SEPTIC SHOCK AS NOT RELATED TO THE INDEX PROCEDURE, DEVICE OR UNDERLYING CONDITION. THE SPONSOR ASSE

  Patient problems: Confusion/ Disorientation; Pain; Respiratory Insufficiency; Septic Shock

  MAUDE report 20244286 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 55MM AAA . IT WAS NOTED THAT ON THE 2 WEEK CHECK-UP THERE WAS NO ISSUES NOTED. IT WAS REPORTED THAT DURING THE FOLLOW-UP VISIT THE PATIENT REVEALED THAT THEY WERE OUT WALKING THE PREVIOUS WEEK AFTER A SNOWSTORM AND FELL DOWN. THE PATIENT FOLLOWED UP WITH THE PHYSICIAN AND FOUND DIMINISHED PULSES IN THE LEFT LEG VIA ULTRASOUND. A CT SCAN WAS PERFORMED WHICH SHOWED A LEFT LIMB OCCLUSION WHICH WAS PRESENT FROM THE BIFURCATION DOWN TO THE COMMON FEMORAL ARTERY. THE CT ALSO SHOWED A DISSECTION IN THE DISTAL COMMON AND PROXIMAL EXTERNAL ILIAC ARTERY. ONE DAY LATER INTERVENTION WAS PERFORMED. A NON MDT THROMBECTOMY DEVICE WAS USED TO SUCK OUT THE CLOT AND THE LIMB WAS RELINED USING ANOTHER ENDURANT II LIMB. A BALLOON EXPANDABLE STENT WAS PLACED AT THE AORTIC BIFURCATION AND A SELF-EXPANDING STENT AT THE EXTERNAL ILIAC. THE BALLOON EXPANDABLE STENTS WERE PLACED TO RELINE AND TO PROVIDE EXTRA SUPPORT TO THE NATIVE BIFURCATION. THE INTERVENTION WAS SUCCESSFUL. PER THE PHYSICIAN THE CAUSE OF THE OCCLUSION AND DISSECTION WAS TRAUMA DUE TO THE FALL. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 18650625 ↗
• MalfunctionJan 5, 2024Difficult to Remove; Difficult to Remove

  AN ENDURANT II STENT GRAFT LIMB ETLW1616C146EE WAS IMPLANTED AS PART OF THE ENDOVASCULAR TREATMENT OF A 65MM AAA. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE ENDURANT LIMB DEPLOYED ACCURATELY HOWEVER WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE DELIVERY SYSTEM BY ENGAGING THE GREY TRIGGER, THE TRIGGER WOULD NOT RELEASE. AFTER MULTIPLE ATTEMPTS THE PHYSICIAN PULLED THE DEVICE OUT WITHOUT RECAPTURING THE TIP. IT WAS NOTED THAT THERE WAS NO HARM TO THE PATIENT AS THE PHYSICIAN HAD DONE CUTDOWNS ON THE COMMON FEMORAL ARTERIES. THE DELIVERY SYSTEM WAS PULLED OUT WITHOUT BRINGING THE FRONT GRIP TO THE SLIDER. PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18450794 ↗
• InjuryJul 21, 2023Obstruction of Flow; Detachment of Device or Device Component; Obstruction of Flow; Detachment of Device or Device Component

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 50MM AAA.  IT WAS REPORTED A CT WAS PERFORMED APPROXIMATELY 4 MONTHS POST THE INDES PROCEDURE, WHICH REVEALED THE PROXIMAL PORTION OF THE ENDURANT LIMB 16X16X146  WAS COMPRESSED WITH THROMBUS FORMATION.  THE CT ALSO REVEALED A STENT STRUT LYING TRANSVERSE ACROSS THE PROXIMAL PORTION OF THE 16X16X93 LIMB. THERE APPEARS TO BE A STENT THAT IS DETACHED. IT WAS ALSO NOTED THAT THERE ARE MISPLACED STENTS SEEN ON THE CT BUT IT IS UNDETERMINED IF THEY ARE FROM THE BIFURCATE STENT GRAFT OR THE LIMB STENT GRAFT. THERE WAS NO RESTRICTION OF FLOW OR THROMBUS NOTED IN THE 16 X 16 X 90 LIMB OT ENDURANT BIFURCATE. THE PATIENT IS ASYMPTOMATIC.  PER THE PHYSICIAN THE CAUSE COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Cardiac Arrest; Insufficient Information; No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 17369625 ↗
• InjuryMar 29, 2023Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED A FOLLOW UP CT IDENTIFIED A TYPE IB ENDOLEAK AND THAT THE ENDURANT LIMBS WERE TOO SHORT. IT WAS CONFIRMED THERE IS NO COMPLAINT AGAINST THE MAIN BODY BIFURCATE STENT GRAFT. ON THE SAME DATE, INTERVENTION WAS PERFORMED WHERE BOTH LIMBS WERE EXTENDED WITH 2 ADDITIONAL ENDURANT LIMBS. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK WAS DUE TO THE ORIGINAL LIMBS BEING TOO SHORT DUE TO A VERY POSTERIOR CIA ON BOTH SIDES. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 16636580 ↗
• MalfunctionOct 11, 2022Obstruction of Flow; Obstruction of Flow

  AN ENDURANT II LIMB WAS INTENDED TO BE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A  52.6MM AAA.  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE STENT GRAFT WAS OPENED USUAL, THE TECHNICIAN MET RESISTANCE WHEN FLUSHING THE STENT GRAFT. ONCE THIS OCCURRED, A WIRE WAS THEN ATTEMPTED TO BE PASSED THROUGH THE STENT GRAFT, BUT STOPPED JUST SHY OF THE TAPERED TIP. MULTIPLE ATTEMPTS WERE MADE BUT THE WIRE WOULD NOT GO THROUGH THE STENT. IT WAS THEN DECIDED TO ABANDON THE USE OF THIS STENT GRAFT AND ANOTHER LIMB WAS IMPLANTED INSTEAD.  PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15578414 ↗
• MalfunctionJul 28, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AN ENDURANT II LIMB WAS INTENDED TO BE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED ONCE THE GRAFT WAS OPENED A HUMAN HAIR WAS NOTED STICKING OUT AND WEDGED INTO THE DEPLOYMENT SYSTEM. IT IS STATED THE HAIR COULD NOT HAVE BEEN FROM ANYONE IN THE ROOM AS IT WAS NOTICED BEFORE THE SCRUB TECH RECEIVED THE GRAFT AND THE HAIR WAS WEDGED INTO THE END OF THE DEPLOYMENT SYSTEM. IT IS SUSPECTED THE HAIR CAME FROM THE MANUFACTURING FACILITY. THE ATTENDING SALES REPRESENTATIVE PULLED OUT THE HAIR AFTER IT WAS DECIDED THE DEVICE COULDN'T BE USED AND THE HAIR BROKE IN TWO PIECES, ONE REMAINED JAMMED IN THE DEPLOYMENT SYSTEM, THE DEVICE WAS THEN DISCARDED. AS PER THE PHYSICIAN THE CAUSE CANNOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15121406 ↗

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-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-0290-2022 · Oct 15, 2021 · Open, Classified
  Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
• 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 infra
• 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 aortoili
• 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