Endurant® II ETCF2525C49ERecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00613994991430), received between Mar 2, 2017 and Aug 8, 2023 — classified as 1 death, 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (9 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 16, 2026.

Recalls naming this device

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 · 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-0291-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2023Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 53MM ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK DIAMETER WAS NOTED AS 18MM AND 20MM IN LENGTH. SEVERE NECK ANGULATION AND MILD NECK CALCIFICATION WERE OBSERVED.  IT WAS REPORTED DURING THE INDEX PROCEDURE, THE MAIN BODY AND CONTRA LIMB WERE SUCCESSFULLY DEPLOYED. AFTER DEPLOYMENT OF IPSI LIMB (IN RIGHT ILIAC), THE PHYSICIAN HAD DIFFICULTY PERFORMING THE ¿GRAY TO BLUE¿ MANEUVER. MORE FORCE THAN NECESSARY WAS REPORTED TO BE REQUIRED, HOWEVER, THE PHYSICIAN ULTIMATELY DECIDED TO CEASE THAT EFFORT AND SIMPLY PULL THE DELIVERY SYSTEM THROUGH THE LIMB AND INTO THE SENTRANT SHEATH. AFTER THE DELIVERY SYSTEM WAS REMOVED, THE PHYSICIAN WAS EASILY ABLE TO PERFORM THE GRAY TO BLUE MANEUVER. UPON RETURNING TO THE SCREEN AND VIEWING THE PROXIMAL MAIN BODY, IT WAS OBSERVED THAT THE GRAFT AND PROXIMAL CROWN WERE NOW POSITIONED DISTAL TO THE ORIGINAL LANDING ZONE WHERE IT HAD BEEN PLACED. DUE TO THE NECK ANGULATION, THE CROWN AND FABRIC IN THE FIRST 20MM OF THE GRAFT DID NOT APPOSE THE WALL OF AORTIC NECK CAUSING A LARGE TYPE IA ENDOLEAK. IN AN ATTEMPT TO FIX THIS THE PHYSICIAN IMPLANTED A 25 ENDURANT CUFF ((

  Patient problems: Insufficient Information

  MAUDE report 17478909 ↗
• DeathMar 9, 2023Adverse 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 53MM SACCULAR AAA. IT WAS REPORTED DURING THE PROCEDURE, AFTER IMPLANTING THE MAIN BODY AND A LIMB, THE PHYSICIAN BEGAN VERY LIGHTLY BALLOONING THE PROXIMAL NECK SEAL ZONE. WHILE BALLOONING THERE WAS A CHANGE IN DIAMETER OF THE PROXIMAL NECK AND A RUPTURE WAS CONFIRMED. IT WAS CONFIRMED IT WAS A RELIANT BALLOON USED DURING THE INDEX PROCEDURE. THE PATIENTS BLOOD PRESSURE DROPPED AND SUSTAINED BALLOON INFLATION WAS USED TO MAINTAIN SYSTOLIC PRESSURE. THE PHYSICIAN  THEN OBTAINED LEFT ARM ACCESS AND USED A CHIMNEY TECHNIQUE TO PLACE A NON MDT STENT INTO THE LEFT RENAL ARTERY AND SUBSEQUENTLY PLACED A 25/25/49 AORTIC CUFF TO THE LEVEL OF THE RIGHT RENAL ARTERY.  AFTER BALLOONING,  THE CUFF HELPED SLOW THE EXTRAVASATION IN THE PROXIMAL NECK BUT THE PATIENT CONTINUED TO BE UNSTABLE AND THE PATIENT WAS  CONVERTED TO AN OPEN SURGICAL REPAIR. THE PHYSICIANS EXPLANTED THE CUFF AND THE BIFURCATED GRAFT EXCEPT FOR THE LIMBS, THE PHYSICIANS CUT OFF THE LIMBS DISTAL TO THE FLOW DIVIDER AND SEWED A AORTO BI-FEM GRAFT INTO THE EXISTING ENDOGRAFT LIMBS. THE PHYSICIAN REMOVED THE NON MDT STENT FROM THE LEFT

  Patient problems: Ischemia; Low Blood Pressure/ Hypotension; Thrombosis/Thrombus

  MAUDE report 16512800 ↗
• InjuryJan 13, 2023Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 51MM AAA ON THE (B)(6) 2022.  IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT GRAFTS WERE IMPLANTED UNEVENTFULLY. DUE TO A NARROW DISTAL AORTA, PTA BALLOONS WERE USED TO OPEN LUMENS. AN ANGIOGRAM WAS PERFORMED AND AN ENDOLEAK WAS PRESENT. THE PHYSICIAN WAS UNABLE TO DETERMINE EXACT SOURCE OF THE LEAK. THERE WAS EXTRAVASATION FROM THE LEAK, AND THE PATIENT BECAME ACUTELY HYPOTENSIVE. A CONFORMABLE BALLOON WAS USED TO OCCLUDE AORTA AND STABILIZE THE  PATIENT. FOLLOW ON ANGIOGRAMS WERE INCONCLUSIVE, THE LEAK PERSISTED. A CUFF WAS PLACED DUE TO POSSIBLE IA OR TYPE IV  ENDOLEAK. THE PATIENT CONTINUED TO BE UNSTABLE AND THE PATIENT WAS CONVERTED TO OPEN REPAIR. THE BIFURCATE STENT GRAFT WAS SUSPECTED OF CONTAINING THE UNKNOWN ENDOLEAK BUT IT IS NOT KNOWN. IT WAS CONFIRMED THE IMPLANT OF THE ENDURANT CUFF DID NOT MAKE ANY IMPACT TO THE ENDOLEAK. THE BIFURCATE AND AORTIC CUFF  WERE DISSECTED BELOW THE M STENT AND SEWED INTO A SURGICAL GRAFT. THE OTHER STENT GRAFTS WERE PARTIALLY DISSECTED AND SEWED INTO A SURGICAL GRAFT AND REMOVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERM

  Patient problems: Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 16156187 ↗
• MalfunctionMay 6, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR FOLLOW-UP APPROXIMATELY 9 MONTHS POST THE INDEX PROCEDURE, AN ENDOLEAK WAS NOTED ON A CTA . THE PATIENT IS DOING WELL WITH NO SYMPTOMS. IT WAS SAID IT COULD BE A TYPE IB OF THE RIGHT ILIAC, POSSIBLE TYPE III OR A  POSSIBLE TYPE II ENDOLEAK.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14304903 ↗
• InjuryMar 11, 2021Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM <(>&<)> ENDURANT AORTIC CUFF EXTENSION WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED ON AN UNKNOWN DATE OF CT A UNDETERMINED TYPE ENDOLEAK WAS IDENTIFIED. INTERVENTION WAS PERFORMED APPROXIMATELY TWO MONTHS POST INDEX PROCEDURE AND ENDOANCHORS WERE IMPLANTED BUT THERE WAS NO CHANGE TO THE ENDOLEAK. IT WAS SAID THE ENDOLEAK WAS PROBABLY A TYPE II. NO FURTHER INTERVENTION WAS PERFORMED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DIFFICULT ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 11461144 ↗
• InjuryJul 14, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 49MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED WHEN THE PATIENT RETURNED FOR FOLLOW-UP A CT PERFORMED ON FIVE MONTHS LATER, REVEALED ANEURYSM ENLARGEMENT WITH AN UNKNOWN ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY AND IT WAS REPORTED THAT A SEVERE ANGULATED NECK MAY HAVE CONTRIBUTED TO ISSUE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm; Injury

  MAUDE report 10270424 ↗
• MalfunctionMar 23, 2020Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATE AND AN ENDURANT LIMB WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 80MM ABDOMINAL AORTIC ANEURYSM. IT WAS NOTED THAT WHEN THE PATIENT RETURNED FOR FOLLOW-UP, A CT PERFORMED SEVEN YEARS AND SEVEN MONTHS LATER SHOWED A TYPE IA ENDOLEAK WAS PRESENT IN THE BIFURCATE. A ENDOLEAK TYPE IB WAS PRESENT IN THE RIGHT COMMON ILIAC ARTERY IN THE ENDURANT LIMB ALSO. SIXTEEN DAYS POST THE CT, THIS PATIENT WAS BROUGHT TO OR. A 25X25X49 ENDURANT CUFF WAS DEPLOYED TO THE LEVEL OF THE LOWEST (RIGHT) RENAL ARTERY AND SUBSEQUENTLY 6 ENDOANCHORS WERE DEPLOYED IN THE LATERAL AND POSTERIOR RIGHT AND LEFT OBLIQUE REGIONS OF THE PROXIMAL CUFF IN AN UNSUCCESSFUL ATTEMPT TO SEAL THE TYPE 1A ENDOLEAK. AS PER THE PHYSICIAN IT WAS DETERMINED THAT A POSTERIOR CHUNK OF CALCIUM AT THE LEVEL OF THE PROXIMAL SEAL ZONE IN THE AORTA WAS CREATING A GUTTER THAT PREVENTED THE CUFF FROM ACHIEVING A COMPLETE PROXIMAL SEAL. TO ADDRESS THE TYPE IB ENDOLEAK A 16X13X156 TAPERED ENDURANT LIMB WAS USED TO EXTEND SEAL INTO THE RIGHT EXTERNAL ILIAC ARTERY. AFTER THIS WAS IMPLANTED, THE PHYSICIAN IMPLANTED AN ADDITIONAL 16X13X124 LIMB TO EXTEND THE DISTAL SEAL AN ADDITIONAL 1.5-2CM. THE COMPLETION ANGIOGRAM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9864505 ↗
• InjuryAug 12, 2019Malposition of Device; Malposition of Device

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE LENGTH OF THE PROXIMAL AORTIC NECK WAS 8 MM, WITH A DIAMETER OF 18 MM AT THE RENAL ARTERY. THE ANGULATION WAS 45 DEGREES. MODERATE VESSEL TORTUOSITY AND MILD VESSEL CALCIFICATION WAS PRESENT. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, UPON DEPLOYMENT OF THE SUPRARENAL STENT, THE DELIVERY SYSTEM "THUMBWHEEL" BROKE. THE PHYSICIAN STATED THAT WHILE DEALING WITH THE BROKEN THUMBWHEEL, THE IMPLANTED DEVICE SLIPPED DOWN FROM THE TARGET LANDING ZONE. AN ANGIOGRAM THEN REVEALED A TYPE I ENDOLEAK. A PROXIMAL CUFF WAS THEN IMPLANTED AND THE TYPE I ENDOLEAK WAS RESOLVED. IT WAS REPORTED THAT A FOLLOW-UP CT SCAN THE NEXT DAY SHOWED THAT BOTH OF THE RENAL ARTERIES WERE COVERED BY THE PROXIMAL CUFF. A SECONDARY INTERVENTION WAS THEN PERFORMED, WITH BILATERAL RENAL STENTS SUCCESSFULLY IMPLANTED TO RESTORE FLOW. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 8882707 ↗
• MalfunctionApr 30, 2019Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 43MM X 30MM PAU. THE PAU WAS LOCATED 6MM BELOW THE LOWEST RENAL ARTERY. THE PROCEDURE WAS COMPLETED UNDER SHORT NECK INDICATION. IT WAS NOTED THE PATIENT HAD VERY TORTUOUS ILIAC ARTERIES. THE PHYSICIAN OPTED TO IMPLANT A CUFF ONLY AS THE LEAST INVASIVE OPTION DUE TO PATIENT MEDICAL CONDITION. IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER AN ENDURANT CUFF (25/25/70) WAS IMPLANTED AN ANGIOGRAM PERFORMED IDENTIFIED FILLING OF THE ANEURYSM WITH CONTRAST WITH A TYPE IA ENDOLEAK. THE PHYSICIAN BALLOONED THE PROXIMAL NECK WITH A RELIANT BALLOON. ANOTHER ANGIOGRAM WAS COMPLETED AND ALTHOUGH THE FILLING OF THE ANEURYSM WAS LESS, IT STILL WAS NOT COMPLETELY RESOLVED. THE PHYSICIAN THEN PLACED 3 ENDOANCHORS. WHEN ATTEMPTING TO PLACE A 4TH ENDOANCHOR, IT PENETRATED THE WALL DURING THE FIRST PART OF DEPLOYMENT BUT UPON 2ND PART OF DEPLOYMENT THE ENDOANCHOR JUMPED UP AND BECAME FREE FLOATING IN THE AORTA. ATTEMPTS WERE MADE TO SNARE THE ENDOANCHOR WITHOUT SUCCESS. AS THE TYPE TYPE IA ENDOLEAK REMAINED THE PHYSICIAN THEN PLANNED TO IMPLANT AN ADDITIONAL CUFF COVERING THE ACCESSORY RENALS LANDING U

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8564873 ↗
• MalfunctionJan 23, 2019Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM. THE PATIENT HAD A SHORT ANGULATED AND CALCIFIED NECK. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE FINAL ANGIOGRAM SHOWED THAT THE BIFURCATED STENT GRAFT HAD LANDED APPROXIMATELY 5MM BELOW THE RIGHT RENAL ARTERY AND THAT THERE WAS A TYPE IA ENDOLEAK. THE PHYSICIAN IMPLANTED AN ENDURANT CUFF ETCF2525C49E AS TREATMENT BUT A SMALL TYPE IA ENDOLEAK REMAINED. IT WAS REPORTED THE ENDOLEAK WAS EXPECTED TO RESOLVE ONCE THE HEPARIN HAD WORN OFF. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO THE PATIENTS CALCIFIED ANGULATED NECK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8270791 ↗
• InjuryMar 2, 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 RECENT CT REVEALED A PROXIMAL TYPE I ENDOLEAK AND A RECENT ANGIOGRAM CONFIRMED THE PROXIMAL TYPE I ENDOLEAK. A 25X25 ENDURANT AORTIC CUFF WAS IMPLANTED IN THE PROXIMAL PORTION OF THE ENDURANT BIFURCATED STENT GRAFT HOWEVER THE PROXIMAL TYPE I ENDOLEAK WAS NOT RESOLVED. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER MANUFACTURER¿S 40X10 BARE METAL STENT MOUNTED ON A BALLOON AT THE LEVEL OF THE ENDURANT BIFURCATED STENT GRAFT, BECAUSE THE OTHER MANUFACTURER¿S STENT COULD NOT BE ADVANCED TO THE INTENDED LANDING ZONE. THE PHYSICIAN INSERTED ANOTHER MANUFACTURER¿S 16X35CM SHEATH ENABLING ADVANCEMENT AND DEPLOYMENT OF A SECOND DEVICE (ANOTHER MANUFACTURER¿S STENT ON ANOTHER MANUFACTURER¿S BALLOON) AT THE LEVEL OF THE ENDURANT AORTIC CUFF. AN ANGIOGRAM WAS PERFORMED AND THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED. THE PHYSICIAN STATED THAT THE CAUSES OF THE PROXIMAL TYPE I ENDOLEAK COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6375133 ↗

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, Classified
  Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
• 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-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 i
• 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 aort
• 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