Endurant® II ETCF2323C49ERecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00613994991423), received between Nov 20, 2017 and Mar 8, 2023 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 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 ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT CUFF WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE TO REPAIR AN ACCIDENTAL PINHOLE CREATED IN THE DISTAL AORTA CAUSED DURING SPINE SURGERY . IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, AFTER PLACING THE CUFF IN THE DISTAL AORTA, BALLOONING WAS PERFORMED. EXTRAVASATION WAS SEEN ON IMAGING AND AN AORTIC RUPTURE WAS NOTED. THE PHYSICIAN THEN CONVERTED TO OPEN PROCEDURE WHERE THE ENDURANT CUFF WAS EXPLANTED. THERE WAS NO NOTED MALFUNCTION OBSERVED WITH THE ENDURANT CUFF. THE CAUSE OF THE EXTRAVASATION WAS NOTED TO BE FROM THE RUPTURED AORTA. NO ADDITIONAL CLINICAL SEQUELAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Rupture

  MAUDE report 16500754 ↗
• InjuryJul 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE THE PATIENT DEVELOPED COLD FEET POST A NON-AORTIC RELATED SURGICAL INTERVENTION. CT DEMONSTRATED STENT GRAFT THROMBOSIS. INTERVENTION WAS COMPLETED WHERE AND AX-BI FEM WAS PLACED AND THE PATIENT HAD A LOWER EXTREMITY AMPUTATION . PER THE PHYSICIAN THE CAUSE OF THE STENT GRAFT THROMBOSIS WAS NOT DEVICE RELATED BUT RELATED TO THE CEASING OF BLOOD THINNERS PRIOR TO THE NON-AORTIC RELATED SURGERY AND PROLONGED SURGERY TIME.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14882841 ↗
• MalfunctionJun 27, 2022Malposition of Device; Malposition of Device

  A HELI-FX ENDOANCHORING SYSTEM WAS USED PROPHYLACTICALLY WITH AN ENDURANT CUFF IN THE ENDOVASCULAR TREATMENT OF A A PAU IN THE DISTAL AORTA. A  SHORT DISTAL LANDING ZONE DISTAL OF THE PAU TO THE AORTIC BIFURCATION WAS PRESENT AND IT WAS DECIDED TO USE AN AORTIC CUFF DUE TO THE RENAL TO BIFURCATION LENGTH.  IT WAS REPORTED DURING THE PROCEDURE, AFTER PLACEMENT OF THE AORTIC CUFF THE PHYSICIAN USED THE ENDOANCHORS TO AID FIXATION ON THE GRAFT AT  THE PROXIMAL AND DISTAL LANDING ZONES. WHEN THEAPPLIER WAS TURNED ON  THE MOTOR SOUNDED VERY SLOW AND DIFFERENT THAN NORMAL. THE ENDOANCHOR DID LOAD AND IT WAS CHECKED TO MAKE SURE THE ENDOANCHOR  WAS LOADED. 4 ENDOANCHORS WERE THEN PLACED AT THE TOP OF THE AORTIC CUFF.  THE MOTOR SOUNDED VERY SLOW THE ENTIRE TIME. NEXT THE PHYSICIAN WENT TO THE DISTAL AORTA AND PLACED THE FIRST ENDOANCHOR ON THE PATIENTS RIGHT SIDE. WHEN THE PHYSICIAN WENT TO PLACE THE SECOND ENDOANCHOR, THE PHYSICIAN  WENT TO STAGE ONE AND THE ANCHOR WENT STRAIGHT TO DEPLOYMENT, IT DID NOT STOP. THE ANCHOR WAS NOT ALIGNED PROPERLY AND WENT IN AT A STEEP ANGLE. THIS CAUSED THE BOTTOM OF THE STENT GRAFT TO BE PUSHED UP. IT WAS NOTED THAT THE PHYSICIAN HAD NOT SEEN AN APPLIER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14828294 ↗
• InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II AORTIC EXTENSION STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 58MM ABDOMINAL AORTIC ANEURYSM. THE DIAMETER OF THE AORTA AT THE RENAL ARTERY WAS 16MM. LENGTH OF PROXIMAL AORTIC NECK WAS 8MM. 30 DEGREE CRANIAL ANGULATION, MODERATE TO SEVERE VESSEL TORTUOSITY AND MILD CALCIFICATION WERE ALSO NOTED. IT WAS REPORTED DURING THE INDEX PROCEDURE THE GRAFT COVERED THE PATIENTS RENAL ARTERIES. THE PHYSICIAN LEFT THE GRAFT IN PLACE AND ADDED A DIALYSIS CATHETER.  AS PER THE PHYSICIAN THE CAUSE OF THE OCCLUSION CANNOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14285359 ↗
• InjuryApr 29, 2021Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 61 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, AFTER THE 23X14X103 BIFURCATE STENT GRAFT AND THE 16X13X124 LIMB (LEFT) AND 16X16X124 (RIGHT) LIMB WERE PLACED, BALLOONING WAS PERFORMED AN ANGIOGRAM WAS THEN PERFORMED, WHERE IT WAS NOTED WHAT APPEARED TO BE A ENDOLEAK TYPE 1A. THE DOCTOR THEN RE-BALLOONED THE PROXIMAL AORTA AND THE PATIENT'S BLOOD PRESSURE DROPPED. ANGIOGRAM WAS THEN PERFORMED AND IT LOOKED AS IF THERE WAS A RUPTURE. THE PHYSICIAN THEN PLACED AN OCCLUSION BALLOON AND AN ENDURANT CUFF. AFTER DEPLOYMENT OF THE CUFF, THE PROXIMAL NECK WAS BALLOONED AGAIN AND THE PATIENT'S BLOOD PRESSURE WAS STILL NOT STABLE. ANGIOGRAM WAS PERFORMED AND NOTED THAT THE SAC WAS FILLING. THE PHYSICIAN THEN PUT THE OCCLUSION BALLOON BY THE PROXIMAL PART OF GRAFT AND TOOK AN ANGIO IN THE MAIN BODY AND AN EXTRAVASATION WAS OBSERVED. TWO 16X16 ILIAC LIMBS LANDING ABOVE THE FLOW DIVIDER PARTIALLY INTO THE CUFF WERE THEN IMPLANTED TO SEAL WHAT APPEARED TO BE AN ENDOLEAK TYPE LLL. AFTER DEPLOYMENT OF THE LIMBS, THE LIMBS WERE SIMULTANEOUSLY BALLOONED AND THE PATIEN

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 11745399 ↗
• InjurySep 2, 2020Malposition of Device; Malposition of Device

  ENDURANT AORTIC CUFFS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 40MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE DEVICES WERE PLACED JUST BELOW THE RIGHT RENAL ARTERY. UPON FINAL ANGIOGRAM, IT WAS FOUND THE RIGHT RENAL ARTERY WAS PARTIALLY COVERED. AN UNSUCCESSFUL ATTEMPT WAS MADE TO CANNULATE THE RENAL ARTERY TO PLACE A STENT. IT WAS NOTED THEN, THE SUPERFICIAL FEMORAL ARTERY (SFA) HAD NO FLOW. THE ACCESS WAS OPENED AND AN ARTERIAL EMBOLECTOMY CATHETER WAS USED TO TREAT THIS. IT WAS DETERMINED THAT THE C ARM IMAGING WAS NOT DOING DIGITAL SUBTRACTION, THAT IT PROVIDED A FALSE POSITIVE TO OCCLUSION ON THE RIGHT SIDE. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Occlusion

  MAUDE report 10481549 ↗
• InjuryMay 1, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AN ENDURANT II AORTIC EXTENSION WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A PENETRATING ATHEROSCLEROTIC ULCER (PAU) DISTAL TO COARCTATION. THE ENDURANT II AORTIC EXTENSION ETCF2323C49E WAS DEPLOYED AND THE GRAFT OPENED SUCCESSFULLY BUT THE SUPRARENAL STENTS WOULD NOT RELEASE. IT WAS REPORTED THE BACK END WHEEL MECHANISM WAS FUNCTIONING. A BALLOON WAS INFLATED WITHIN THE STENTS IN ATTEMPT TO RELEASE THE SUPRARENAL STENTS. THE DELIVERY SYSTEM WAS EVENTUALLY REMOVED, AND UPON SEVERAL ATTEMPTS AT BALLOONING THE SUPRARENAL STENTS, THEY EXPANDED. THE EVENT WAS RESOLVED. THE PHYSICIAN HAS REPORTED THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7474981 ↗
• MalfunctionNov 20, 2017Leak/Splash; Leak/Splash

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¿S ANATOMY; SEVERE ANTERIOR AORTIC NECK ANGLE, SEVERE LEFT ANGLE IN A VERY SHORT, CONICAL NECK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED BY THE PHYSICIAN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7044461 ↗

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, 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-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-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