AFX Endovascular AAA System BA28-110/I16-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00818009014160), received between Apr 13, 2016 and Jan 26, 2024 — classified as 1 death, 15 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2024Fracture; Lack of Effect; Fracture; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT, A SUPRARENAL AORTIC EXTENSION AND AN INFRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY EIGHT (8) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, THE PATIENT WAS FOUND TO HAVE ANEURYSM ENLARGEMENT WITH NO IDENTIFIABLE ENDOLEAK. THE ORIGINALLY IMPLANTED STENT GRAFTS WERE RELINED WITH AN AFX2 BIFURCATED STENT GRAFT, A SUPRARENAL AORTIC EXTENSION AND AN INFRARENAL AORTIC EXTENSION. IT WAS REPORTED THIS SECONDARY PROCEDURE WENT WELL AND THERE WAS NO IDENTIFIABLE ENDOLEAK AFTER THE PROCEDURE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 18588552 ↗
• InjuryNov 16, 2023Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL ON (B)(6) 2017. FOLLOW-UP COMPUTED TOMOGRAPHY PERFORMED ON (B)(6) 2023 IDENTIFIED A POSSIBLE TYPE IIIB ENDOLEAK. REINTERVENTION WAS COMPLETED ON (B)(6) 2023 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND TWO (2) AFX VELA INFRARENAL. FINAL PATIENT STATUS HAS NOT BEEN REPORTED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 18154848 ↗
• InjuryJul 27, 2021Material Puncture/Hole; Unintended Movement; Separation Problem; Material Puncture/Hole; Unintended Movement; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX BIFURCATED STENT GRAFT AND VELA SUPRARENAL PROXIMAL EXTENSION. APPROXIMATELY FIVE AND A HALF (5.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A FABRIC TEAR AND A COMPONENT SEPARATION; THESE OBSERVATIONS ARE CLASSIFIED AS A TYPE IIIB ENDOLEAK AND IIIA ENDOLEAK, RESPECTIVELY. THE PATIENT IS REPORTEDLY ASYMPTOMATIC. IT IS UNKNOWN IF THE PHYSICIAN PLANS TO RE-INTERVENE.

  Patient problems: Failure of Implant

  MAUDE report 12235490 ↗
• InjuryJul 14, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH A BIFURCATED DEVICE AND TWO SUPRARENAL AORTIC EXTENSIONS. APPROXIMATELY (1) ONE-MONTH POST INITIAL PROCEDURE, A 1A ENDOLEAK WAS IDENTIFIED DURING A ROUTINE FOLLOW-UP. A RE-INTERVENTION WAS DONE, AND THE PHYSICIAN ELECTED TO IMPLANT AN AFX VELA SUPRARENAL (MFR# 2031527-2015-00208). NOW APPROXIMATELY (6) SIX YEARS POST-RE-INTERVENTION THE PATIENT WAS PRESENTED TO THE EMERGENCY ROOM (E/R) DUE TO AN ENDOLEAK TYPE 3A AND AORTA RUPTURE. A RE-INTERVENTION WAS DONE AND THE PHYSICIAN IMPLANTED A (NON-ENDOLOGIX) GORE EXCLUDER GRAFT. THE FINAL PATIENT STATUS WAS REPORTED AS DOING WELL.

  Patient problems: Failure of Implant; Rupture

  MAUDE report 12168133 ↗
• InjuryMar 5, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A AFX BIFURCATED STENT GRAFT AND A VELA SUPRARENAL STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, AN ENDOLEAK OF AN INDETERMINATE ORIGIN WITH SAC GROWTH WAS IDENTIFIED. THE PATIENT WAS PART OF A CLINICAL STUDY AND CURRENTLY BEING MONITORED..

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 11422656 ↗
• InjuryNov 16, 2020Material Puncture/Hole; Separation Problem; Material Puncture/Hole; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND AN INFRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY, 4.5 YEARS POST INITIAL PROCEDURE, A TYPE 3A ENDOLEAK WITH DEVICE SEPARATION AND A TYPE 3B ENDOLEAK OF THE INFRARENAL STENT GRAFT WERE IDENTIFIED. A RE-INTERVENTION WAS COMPLETED ON (B)(6)2020. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICE AND PERFORM AN OPEN REPAIR. THE PATIENT WAS REPORTED IN GOOD CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 10848765 ↗
• InjuryAug 26, 2019Insufficient Device Problem Information; Separation Problem; Insufficient Device Problem Information; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 3.5 YEARS POST INITIAL PROCEDURE (EXACT DATE WAS NOT PROVIDED), A TYPE 3A ENDOLEAK WITH SEPARATION AND SAC GROWTH WAS REPORTED. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO BRIDGE THE MAIN BODY WITH A SUPRARENAL STENT GRAFT EXTENSION WHICH SUCCESSFULLY RESOLVED THE REPORTED EVENT. THE PATIENT WAS REPORTED AS DOING FINE AND WAS DISCHARGED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8933081 ↗
• InjuryAug 8, 2019Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; 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 3.5 YEARS POST INITIAL PROCEDURE, A POSSIBLE 3B ENDOLEAK WAS REPORTED. THE PATIENT IS BEING MONITORED AND THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT REFUTED THE TYPE IIIB ENDOLEAK; RATHER, THERE IS EVIDENCE OF TYPE IA ENDOLEAK.

  Patient problems: Failure of Implant

  MAUDE report 8874462 ↗
• InjuryMar 11, 2019Migration; Migration

  ADDITIONAL INFORMATION RECEIVED PER MEDWATCH REPORT # MW5084272 CONFIRMING THAT THE PATIENT ALSO PRESENTED WITH A TYPE I ENDOLEAK (UNSPECIFIED TYPE IA OR IB). CLINICAL ASSESSMENT CONFIRMED THE PRESENCE OF A TYPE IA ENDOLEAK.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8410217 ↗
• InjuryFeb 1, 2019Material Puncture/Hole; Product Quality Problem; Material Integrity Problem; Material Puncture/Hole; Product Quality Problem; Material Integrity Problem

  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, A TYPE IIIB ENDOLEAK WAS DETECTED. THE PATIENT IS REPORTEDLY STABLE AND ASYMPTOMATIC, AND THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8298670 ↗
• InjuryDec 27, 2018Leak/Splash; Material Puncture/Hole; Product Quality Problem; Material Integrity Problem; Unintended Movement; Lack of Effect; Leak/Splash; Material Puncture/Hole; Product Quality Problem; Material Integrity Problem; Unintended Movement; Lack of Effect

  ADDITIONAL INFORMATION RECEIVED CONFIRMING THAT THERE APPEARED TO BE A BREACH IN THE FABRIC DOWN THE BIFURCATION (TYPE IIIB ENDOLEAK). THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING WITH A BIFURCATED AFX2, AND INFRARENAL AND SUPRARENAL AFX DEVICES ON (B)(6) 2018. THE PATIENT WAS REPORTEDLY IN STABLE CONDITION.

  Patient problems: Aneurysm; Clinical Endoleak; Failure of Implant

  MAUDE report 8201552 ↗
• InjuryJun 4, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  ENDOLOGIX BECAME AWARE OF AN ABDOMINAL AORTIC ANEURYSM SAC GROWTH ON (B)(6) 2018 AS REPORTED BY PHYSICIAN (B)(6) AT (B)(6). THE REPORTED SAC GROWTH WAS DISCOVERED PER CT SCAN ON AN UNKNOWN DATE WITH NO EVIDENCE OF AN ENDOLEAK. AS THE DATE OF EVENT IS UNKNOWN, THE BEST ESTIMATE (B)(6) 2018 WAS USED. THE PATIENT WAS ORIGINALLY IMPLANTED WITH AN AFX BIFURCATED AND VELA SUPRARENAL ON (B)(6) 2015 BY THE REPORTING PHYSICIAN. DURING RE-INTERVENTION, THE PATIENT WAS TREATED BY IMPLANTING AN AFX2 BIFURCATED STENT GRAFT, VELA SUPRARENAL, AND VELA INFRARENAL ON (B)(6) 2018 BY PHYSICIAN (B)(6). THE PATIENT DID WELL AND WENT HOME THE NEXT DAY.

  Patient problems: Aneurysm

  MAUDE report 7565827 ↗
• InjuryAug 30, 2017Hole In Material; Leak/Splash; Stretched; Hole In Material; Leak/Splash; Stretched

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION. A ROUTINE FOLLOW UP COMPUTED TOMOGRAPHY (CT) SHOWS THE PATIENT HAS A DILATED STENT CAGE, A DECREASE IN ANEURYSM SIZE AND A POTENTIAL TYPE 3B ENDOLEAK. THE PATIENT HAS NOT HAD OR BEEN SCHEDULED FOR A SECONDARY PROCEDURE. THE PATIENT IS REPORTED TO BE IN GOOD CONDITION AND THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 6831648 ↗
• InjuryMay 5, 2016Leak/Splash; Use of Device Problem; Malposition of Device; Unintended Movement; Leak/Splash; Use of Device Problem; Malposition of Device; Unintended Movement

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT, A SUPRARENAL AORTIC EXTENSION AND TWO INFRARENAL AORTIC EXTENSIONS ON (B)(6) 2016. DURING THE INITIAL IMPLANT ONE OF THE PROXIMAL EXTENSIONS WAS PLACED IN A SUBOPTIMAL POSITION RESULTING IN INTRAOPERATIVE STENT MIGRATION LEADING TO A TYPE 1A ENDOLEAK. THE PHYSICIAN IMPLANTED A COMPETITOR STENT TO SEAL THE LEAK. THE ENDOLEAK WAS NOT COMPLETELY SEALED FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. THE PATIENT HAD TWO ULTRA SOUNDS POST IMPLANT AND THE PHYSICIAN BELIEVES THE LEAK IS SEALED. THE PATIENT IS STABLE.

  Patient problems: Failure of Implant

  MAUDE report 5636087 ↗
• DeathApr 25, 2016Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION ON (B)(6) 2016. TWO DAYS POST PROCEDURE THE PATIENT EXPIRED. CAUSE OF DEATH IS UNKNOWN, PATIENT WAS STABLE FOLLOWING INITIAL IMPLANT.

  Patient problems: Death

  MAUDE report 5606466 ↗
• InjuryApr 13, 2016Failure To Adhere Or Bond; Failure To Adhere Or Bond

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT, A SUPRARENAL AORTIC EXTENSION, AND A LIMB EXTENSION ON (B)(6) 2016. UPON FOLLOW UP COMPUTED TOMOGRAPHY (CT) SHOWED A TYPE 3A ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT A INFRARENAL AORTIC EXTENSION TO SEAL THE ENDOLEAK. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 5575519 ↗

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-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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-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-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-0596-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL
• 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-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-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• Z-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• Z-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL

…and 1 more.