AFX Endovascular AAA System BA25-100/I20-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00818009014108), received between Feb 24, 2017 and Jul 5, 2022 — classified as 1 death, 14 injuries.

The most frequently reported specific device problem is “Leak/Splash” (6 reports).

16 other recalls cover devices cleared under the same FDA submission (P040002); 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 5, 2022Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL. APPROXIMATELY SIX AND A HALF (6.5) YEARS POST INITIAL PROCEDURE, ANEURYSM ENLARGEMENT WITH A TYPE IIIB ENDOLEAK WAS IDENTIFIED. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF AN ALTO STENT GRAFT SYSTEM. REINTERVENTION RESULTS WERE GREAT. THE PATIENT WAS DISCHARGED ONE DAY POST-REINTERVENTION AND IS DOING WELL.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 14918328 ↗
• InjuryJun 22, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, A TYPE 3A ENDOLEAK WAS IDENTIFIED. PATIENT IS CURRENTLY BEING MONITORED. NOTE: THIS PATIENT IS PART OF A CLINICAL STUDY CASE. AFTER THE SUBMISSION OF THE FOLLOW-UP REPORT, ADDITIONAL INFORMATION WAS PROVIDED REPORTING THAT REINTERVENTION WAS PERFORMED. A GORE (NON-ENDOLOGIX) MAIN BODY DEVICE WAS IMPLANTED IN THE INFRARENAL LOCATION UNEVENTFULLY. THE CONTRALATERAL GATE WAS THEN CATHETERIZED FROM THE LEFT GROIN ACCESS. THE POSITION WAS CONFIRMED BY SPANNING A FLUSH CATHETER WITHIN THE ENDOGRAFT. A STIFF GUIDEWIRE WAS PLACED THROUGH THE CATHETER AND THEN A MARKING CATHETER WAS PLACED TO MEASURE THE LENGTH FOR CONTRALATERAL LIMB EXTENSION. ANGIOGRAM WAS PERFORMED AND THE LEFT HYPOGASTRIC ARTERY WAS MARKED. A 20MM BELL BOTTOM ILIAC LIMB EXTENSION WAS DEPLOYED UNEVENTFULLY ABOVE THE HYPOGASTRIC ARTERY. A SIMILAR SET OF STEPS WAS PERFORMED ON THE RIGHT SIDE AFTER COMPLETION OF THE MAIN BODY GRAFT DEPLOYMENT AND REMOVAL OF THE ENDOGRAFT DEPLOYMENT SYSTEM. A 20MM BELL BOTTOM ILIAC LIMB EXTENSION WAS DEPLOYED

  Patient problems: Failure of Implant

  MAUDE report 12045021 ↗
• InjuryJan 12, 2021Use of Device Problem; Insufficient Device Problem Information; Separation Problem; Use of Device Problem; Insufficient Device Problem Information; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A TYPE 3A ENDOLEAK AND ANEURYSM ENLARGEMENT WERE IDENTIFIED. THE PHYSICIAN ELECTED TO IMPLANT TWO (2) AORTIC EXTENSIONS ON (B)(6) 2021 TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS STABLE POST SECONDARY PROCEDURE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 11157005 ↗
• InjuryAug 21, 2020Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A INFRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 5.5 YEARS POST INITIAL IMPLANT A TYPE 3B ENDOLEAK WAS IDENTIFIED DURING A ROUTINE FOLLOW UP. PHYSICIAN IS PLANNING AN INTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 10439789 ↗
• InjuryFeb 11, 2020Material Puncture/Hole; Use of Device Problem; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Insufficient Device Problem Information; Material Puncture/Hole; Use of Device Problem; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, TWO (2) SUPRARENAL STENT GRAFT EXTENSION AND TWO (2) LIMB STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 3.5 YEARS POST INITIAL PROCEDURE, A COMPONENT SEPARATION (TYPE 3A ENDOLEAK) WAS REPORTED. THE PATIENT WAS SUCCESSFULLY TREATED WITH A AFX2 BIFURCATED STENT GRAFT, AFX LIMB STENT GRAFT EXTENSIONS, OVATION EXTENDER STENT AND NON-ENDOLOGIX STENTS. THE PATIENT WAS REPORT AS STABLE. ADDITIONAL INFORMATION: DURING THE INVESTIGATION, THERE WAS EVIDENCE TO REASONABLY SUGGEST THAT A TYPE IIIB ENDOLEAK OF THE BIFURCATED STENT GRAFT, STENT BUCKLING AND A TYPE II ENDOLEAK (LUMBAR) HAD OCCURRED.

  Patient problems: Failure of Implant

  MAUDE report 9696502 ↗
• InjuryDec 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY, 4.5 YEARS POST INITIAL PROCEDURE, AN ANGIOGRAM IDENTIFIED A TYPE 1B ENDOLEAK WITH SAC GROWTH. THE PHYSICIAN ELECTED TO COIL, IMPLANT THREE (3) AFX LIMB STENT GRAFT AND ONE (1) OVATION IV EXTENDER STENT GRAFT TO RESOLVE THIS EVENT. REPORTEDLY, PATIENT DID WELL DURING AND POST PROCEDURE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 9508919 ↗
• InjuryAug 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED AORTA AND A POSSIBLE TYPE IIIA OR IIIB ENDOLEAK (LEAK AT AN INDETERMINATE ORIGIN). THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY UNKNOWN MEANS ON (B)(6) 2019. THE PATIENT IS REPORTEDLY DOING WELL AND THE ENDOLEAK WAS CONFIRMED RESOLVED. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Rupture

  MAUDE report 8946116 ↗
• InjuryJan 29, 2019Fracture; Fracture

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, A FRACTURED STENT OF THE BIFURCATED AFX DEVICE WAS CONFIRMED WITH NO ENDOLEAK OR ANEURYSM GROWTH. THE PHYSICIAN PLANS TO RE-INTERVENE AND THE PATIENT IS REPORTEDLY IN GOOD CONDITION. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8284727 ↗
• InjuryDec 14, 2018Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 2.5 YEARS POST INITIAL PROCEDURE, A TYPE 3B ENDOLEAK WITH SAC GROWTH WAS DISCOVERED. A SECONDARY PROCEDURE WAS COMPLETED. THE PHYSICIAN ELECTED TO PERFORM A NON ENDOLOGIX AUI AND PRESUMED FEMORAL FEMORAL BYPASS. THE PATIENT WAS REPORTED AS DOING WELL. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8166977 ↗
• InjuryNov 20, 2018Loss of or Failure to Bond; Leak/Splash; Appropriate Device Problem Term/Code Not Available; Loss of or Failure to Bond; Leak/Splash; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, A TYPE 1B ENDOLEAK AND ANEURYSM SAC GROWTH WAS DETECTED. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN THREE (3) LIMB AFX DEVICES ON (B)(6) 2018. THE PATIENT WAS STABLE WHEN LEAVING THE OPERATING ROOM. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8091579 ↗
• InjuryJul 3, 2018Fracture; Hole In Material; Leak/Splash; Fracture; Hole In Material; Leak/Splash

  PATINET SECONDARY PROCEDURE HAS BEEN PUSHED BACK FROM (B)(6) 2018 TO (B)(6) 2018.

  Patient problems: Failure of Implant

  MAUDE report 7658735 ↗
• InjuryDec 27, 2017Failure To Adhere Or Bond; Collapse; Leak/Splash; Migration or Expulsion of Device; Failure To Adhere Or Bond; Collapse; Leak/Splash; Migration or Expulsion of Device

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT, A SUPRARENAL AORTIC EXTENSION, AND A LIMB EXTENSION. A FOLLOW UP SHOWED THE PATIENT HAD A TYPE 3A ENDOLEAK. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICES AND COMPLETE AN OPEN REPAIR. THE PATIENT IS REPORTED TO BEING DOING WELL AND THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7147496 ↗
• InjuryJul 3, 2017Hole In Material; Leak/Splash; Material Integrity Problem; Hole In Material; Leak/Splash; Material Integrity Problem

  AN AFX BIFURCATED STENT GRAFT WAS IMPLANTED WITH A VELA SUPRARENAL PROXIMAL EXTENSION AND AN OVATION EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE FINAL INTRAOPERATIVE ANGIOGRAM NOTED A TYPE IIIB ENDOLEAK. THE PHYSICIAN DECIDED TO CONCLUDE THE CASE AND MONITOR THE PATIENT. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 6684268 ↗
• DeathJun 29, 2017Entrapment of Device; Difficult to Remove; Failure to Advance; Entrapment of Device; Difficult to Remove; Failure to Advance

  DURING THE INITIAL IMPLANT OF AN AFX ON (B)(6) 2017, THE MAIN BODY WAS DAMAGED AND CAUSED THE GRAFT TO BECOME STUCK ONTO A PREVIOUSLY PLACED GRAFT IN THE MIDDLE OF THE AORTA. AFTER ATTEMPTING TO FREE THE GRAFT, THE PHYSICIAN ELECTED TO PERFORM AN OPEN CONVERSION. THE PATIENT DID NOT TOLERATE THE PROCEDURE AND EXPIRED 1 DAY PROCEDURE.

  Patient problems: Death; Failure of Implant

  MAUDE report 6679549 ↗
• InjuryFeb 24, 2017Failure To Adhere Or Bond; Hole In Material; Leak/Splash; Failure To Adhere Or Bond; Hole In Material; Leak/Splash

  IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2015 WITH A BIFURCATED STENT AND AN INFRARENAL AORTIC EXTENSION. PATIENT HAD ROUTINE FOLLOW UP SCANS WHICH OVER TIME IDENTIFIED AN UNKNOWN ENDOLEAK. ON (B)(6) 2016 A FOLLOW UP SCAN SHOWED A DISTAL ENDOLEAK AND ANEURYSM SAC GROWTH. THE PHYSICIAN BELIEVES THE PATIENT MAY HAVE A POTENTIAL TYPE 1A ENDOLEAK, A POTENTIAL TYPE 2 ENDOLEAK AND A POTENTIAL TYPE 3B ENDOLEAK. IT WAS REPORTED THE PATIENT HAS NO PHYSICAL SYMPTOMS. THERE HAVE BEEN NO REPORTS TO ENDOLOGIX INDICATING A SECONDARY INTERVENTION HAS BEEN SCHEDULED OR COMPLETED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 6358578 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040002. One submission often covers many models, so check the product and lot details in each record.

• Z-1049-2017 · Jan 4, 2017 · Terminated
  AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-80/I20-40 F00820-06 BEA28-120/I16-40 F00820-07 B
• Z-1048-2017 · Jan 4, 2017 · Terminated
  AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C
• Z-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• Z-1054-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-1039-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-1038-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (A
• Z-1037-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-1047-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoili
• Z-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• Z-0593-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• Z-0592-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• Z-0596-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL
• Z-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• Z-0590-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• Z-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL

…and 1 more.