ENDURANT® ENBF2816C166ERecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00613994762481), received between May 9, 2017 and May 1, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (11 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT A PATIENT REPRESENTATIVE CONTACTED TECHNICAL SERVICES APPROXIMATELY 14 YEARS LATER AND STATED THAT THE PATIENT EXPERIENCED AN ENDOLEAK THAT WAS REPAIRED 4 MONTHS PREVIOUSLY WITH AN ENDURANT CUFF. SUBSEQUENT INFORMATION RECEIVED CONFIRMED THAT THE ENDOLEAK WAS A TYPE IA INVOLVING THE ENDURANT BIFURCATED GRAFT. THE ENDOLEAK DID NOT RESOLVE FOLLOWING CUFF IMPLANTATION; THEREFORE, SIX ENDOANCHORS WERE PLACED, RESULTING IN A REDUCTION OF THE ENDOLEAK. THE PHYSICIAN LATER CONFIRMED THAT THE ENDOLEAK WAS FULLY RESOLVED ON FOLLOW-UP IMAGING. LACK OF WALL APPOSITION WAS NOTED IN THE LEFT LIMB; HOWEVER, NO TYPE IB ENDOLEAK WAS IDENTIFIED. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE TYPE IA ENDOLEAK WAS PROGRESSIVE DILATION OF THE AORTA SINCE THE INDEX PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS DOING WELL.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25054506 ↗
• InjuryMay 3, 2024Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM AND AN ANEURX LIMB WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 14 YEARS POST THE INDEX PROCEDURE, THAT THE PATIENT PRESENTED EMERGENTLY EXPERIENCING ABDOMINAL PAIN. A CT SCAN REVEALED A TYPE IA ENDOLEAK WITH A 96MM ABDOMINAL AORTIC ANEURYSM. INTERVENTION WAS PERFORMED, AND AN ENDURANT II/IIS CUFF (ETCF3636C49E) WAS PLACED IN THE RIGHT RENAL ARTERY. THE LEFT RENAL ARTERY WAS COVERED, AND THE RIGHT RENAL WAS STENTED. A FINAL ANGIOGRAM WAS CONDUCTED, AND THE TYPE IA ENDOLEAK WAS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK WAS ANATOMY RELATED DUE TO THE PATIENTS AORTIC NECK DILATATION COMPROMISING THE SEAL OF THE STENT GRAFT. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Abdominal Pain

  MAUDE report 19243522 ↗
• InjurySep 5, 2022Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A PRE-RUPTURED 80 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 11 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED TO ER. A RUPTURE WITH MIGRATION AND TYPE IA ENDOLEAK WERE OBSERVED. THE EVENT WAS TREATED WITH A 32 CUFF PLACEMENT AND SINGLE CHEVAR. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS DUE TO AORTIC NECK DILATION. IT WAS STATED THAT THE PATIENT DID NOT HAVE FOLLOW-UP.  NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information; Rupture

  MAUDE report 15354616 ↗
• InjuryJun 3, 2021Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A ABDOMINAL AORTIC ANEURYSM (GREATER THAN 50MM). IT WAS REPORTED THAT A WEEK LATER, A CT WAS PERFORMED, WHERE A STENT GRAFT SEPARATION WAS NOTED, IN ADDITION TO A TYPE IA ENDOLEAK. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS THAT THE AORTIC NECK DILATED, THEREFORE THE STENT HAD NOTHING HOLDING IT THE AORTIC NECK BUT THE SUPRARENAL STENTS STAYED ATTACHED TO THE AORTA. IT WAS COMMENTED THAT THE MOTION OVER TIME ALLOWED STENTS TO SEPARATE FROM GRAFT. IT WAS REPORTED INTERVENTION WAS PERFORMED WHERE 2 X ENDURANT AORTIC CUFFS WERE IMPLANTED TO BRIDGE THE GAP BETWEEN THE SUPRARENAL STENTS AND GRAFT MATERIAL. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 11930045 ↗
• InjuryMar 12, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. APPROXIMATELY 105 MONTHS POST INDEX PROCEDURE, A HELI FX AAA ENDOANCHORS WERE UNSUCCESSFULLY ATTEMPTED TO BE IMPLANTED TO RESOLVE NECK DILATION . THE PROCEDURE WAS COMPLETED WITH REPLACEMENT DEVICES AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm

  MAUDE report 11472657 ↗
• InjurySep 29, 2020Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 105 MONTHS POST INDEX PROCEDURE, THE PATENT PRESENTED EMERGENTLY WITH A RUPTURED ANEURYSM. CT AND ANGIO INDICATED A TYPE 1 ENDOLEAK AND AAA EXPANDED TO 150MM. IT WAS STATED THAT A CUFF WAS IMPLANTED ALONG WITH ENDOANCHORS TO REPAIR TYPE1A ENDOLEAK. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO ANGULATED AORTIC NECK AND DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUEL WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm; Rupture

  MAUDE report 10598890 ↗
• MalfunctionOct 16, 2019Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT FOLLOW UP CT APPROXIMATELY EIGHT YEARS LATER SHOWED A TYPE IA ENDOLEAK. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS DUE TO DISEASE PROGRESSION OF THE NECK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS BEING MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9195715 ↗
• InjuryAug 9, 2019Leak/Splash; Leak/Splash

  A HELI-FX ENDO-ANCHORING SYSTEM WAS IMPLANTED FOR THE TREATMENT OF NECK DILATION IN AN ENDURANT STENT GRAFT SYSTEM IN A 79.2 ABDOMINAL AORTIC ANEURYSM. AN ENDURANT II LIMB EXTENSION WAS ALSO IMPLANTED DURING THE PROCEDURE. THE ENDURANT STENT GRAFT SYSTEM WAS ORIGINALLY IMPLANTED 5 YEARS EARLIER. THE PROXIMAL AORTIC NECK MEASURED 27.8MM TO 33.9MM. THE NECK LENGTH WAS NOTED AS 7.5MM. IT WAS REPORTED 2.5 YEARS POST ENDO-ANCHOR IMPLANTATION THAT A GUTTER ENDOLEAK FROM THE LEFT RENAL ARTERY STENT WAS OBSERVED. INTERVENTION WITH BALLOON ANGIOPLASTY OF PROXIMAL ENDOGRAFT SEAL ZONE AND KISSING BALLOON ANGIOPLASTY OF THE LEFT RENAL ARTERY STENT WAS COMPLETED WITH THE EVENT CONFIRMED AS RESOLVED. PER THE INVESTIGATOR THE CAUSE OF THE GUTTER ENDOLEAK WAS POSSIBLY RELATED TO A PREVIOUS INTERVENTION/INDEX PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8877728 ↗
• InjuryJul 26, 2019Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A CT APPROXIMATELY EIGHT YEARS SHOWED THE PATIENT HAD A TYPE IA ENDOLEAK. A ENDURANT CUFF ETCF2828C49E WAS IMPLANTED TO TREAT THE ENDOLEAK. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Injury

  MAUDE report 8830625 ↗
• InjuryJul 25, 2018Material Rupture; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF UNKNOWN SIZE. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APROXIMATELY 5 YEARS POST INDEX PROCEDURE WITH ABDOMINAL PAIN. A CT SCAN SHOWED THE PATIENT HAD A CONTAINED ANEURYSM RUPTURE. AN INTERVENTION PROCEDURE WAS CARRIED OUT. TWO ENDURANT STENT GRAFT LIMBS WERE PLACED IN THE EXISTING GRAFT TO EXTEND THE GRAFT INTO THE LEFT COMMON ILIAC ARTERY AND SEAL THE RUPTURE. THE EVENT IS REPORTED TO BE RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Abdominal Pain; Rupture

  MAUDE report 7717594 ↗
• InjuryNov 23, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM ON. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY IN THE EMERGENCY ROOM APPROXIMATELY 5.5 YEARS POST INDEX PROCEDURE WITH A RUPTURED ANEURYSM. THE PATIENT WAS TAKEN TO THE OR WHERE IT WAS OBSERVED THAT THE IPSILATERAL LIMB AND THE EXTENSION LIMB THAT WAS USED TO EXTEND IT IN THE INITIAL PROCEDURE HAD SEPARATED CAUSING A TYPE III ENDOLEAK. THE PHYSICIAN USED OTHER MANUFACTURER¿S DEVICES TO BRIDGE THE SEPARATION AND THE EVENT WAS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 7056720 ↗
• InjuryJul 12, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY AT IMPLANT WAS NOT REPORTED. IT WAS REPORTED THAT AT APPROXIMATELY 23 MONTHS POST IMPLANT AN ANGIOGRAM REVEALED A TYPE II ENDOLEAK. THE PHYSICIAN ELECTED TO COIL THE HYPOGASTRIC ARTERY AND IMPLANT A 16X10X156 ENDURANT LIMB THAT WAS EXTENDED INTO THE RIGHT EXTERNAL ILIAC ARTERY. THE LEFT ILIAC LIMB WAS EXTENDED WITH A 16X24X93 ENDURANT LIMB ABOVE THE LEFT HYPOGASTRIC ARTERY AND A 32X32X49 ENDURANT CUFF WAS IMPLANTED PROXIMALLY. IT WAS REPORTED THAT 24 MONTHS LATER ADDITIONAL A RECENT ULTRASOUND REVEALED THAT THERE WAS ANEURYSM ENLARGEMENT THAT WAS DUE TO AN UNKNOWN ENDOLEAK. A CT WAS NOT PERFORMED. THE NEXT DAY AN AORTAGRAM REVEALED A DISTAL TYPE III SEPARATION ENDOLEAK, THE 16X10X156 ENDURANT STENT GRAFT HAD BEEN PULLED OUT AND SEPARATED FROM THE 16X24X93 ENDURANT LIMB ON THE RIGHT ILIAC LIMB FROM THE ORIGINAL IMPLANT. THE PHYSICIAN IMPLANTED A 16X16X124 ENDURANT ILIAC LIMB TO RECONNECT AND CLOSE THE GAP BETWEEN THE LIMBS. THIS WAS SUCCESSFULLY DONE AND THE ILIAC LIMB WAS BALLOONED. ANOTHER AORTAGRAM WAS PERFORMED AND THE TYPE III SEPARATION

  Patient problems: Injury

  MAUDE report 6707653 ↗
• InjuryMay 9, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT STENT GRAFT AND A HELI-FX ENDOANCHOR SYSTEM WERE IMPLANTED VIA PERCUTANEOUS ACCESS IN A PATIENT FOR ENDOVASCULAR TREATMENT OF A 5.2 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK AT THE RENAL ARTERIES 21 MM IN DIAMETER AND 20 MM BELOW THE RENAL ARTERIES 39 MM IN DIAMETER. THE HELI-FX DEVICE WAS IMPLANTED OUT OF A CONCERN FOR LATE FAILURE. THERE IS CALCIFICATION IN THE PROXIMAL AORTA. IT WAS REPORTED THAT THE PATIENT RETURNED FOR FOLLOW UP. THE CT REVEALED THAT THERE WAS OCCLUSION OF THE LEFT ILIAC LIMB, WHICH EXTENDED UP TO THE BIFURCATED STENT GRAFT. THE PATIENT WAS GIVEN MEDICATION, HOWEVER THE EVENT IS CONTINUING. THE PATIENT HAS A CT THAT REVEALED A TYPE II ENDOLEAK BETWEEN IMA <(>&<)> POSTERIOR LUMBAR BRANCH. AN INFLAMMATORY RIND IN THE ANEURYSM WAS DISCOVERED, THIS RESOLVED WITHOUT TREATMENT. THE PHYSICIAN INVESTIGATOR COULD NOT DETERMINE A CAUSE FOR THE INFLAMMATORY RIND, BUT IT WAS ASSESSED TO BE POSSIBLY RELATED TO THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THE PHYSICIAN.

  Patient problems: Occlusion; Unspecified Infection

  MAUDE report 6555469 ↗

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 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