AFX Endovascular AAA System A25-25/C95-O20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818009010384), received between Mar 22, 2016 and Dec 14, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2017Partial Blockage; Occlusion Within Device; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Partial Blockage; Occlusion Within Device; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  DURING THE INITIAL IMPLANT, IT WAS REPORTED THAT THE PHYSICIAN IMPLANTED A GORE EXCLUDER LEG ON THE RIGHT EXTERNAL ILIAC ARTERY TO THE COMMON ILIAC ARTERY THEN THE AFX WAS IMPLANTED ABOVE THE EXCLUDER LEG, LASTLY AFX PROXIMAL EXTENSION WAS IMPLANTED. ABOUT 8 MONTHS POST IMPLANT, CT SHOWED THROMBOTIC OCCLUSION OF THE RIGHT EXTERNAL ILIAC ARTERY TO THE COMMON ILIAC ARTERY. THE PHYSICIAN ELECTED TO PERFORM A THROMBECTOMY AND PLACED A NEW GORE VIABAHN. IT WAS NOTED BY THE PHYSICIAN THAT THE THROMBOSIS WAS DUE TO PATIENT ANATOMY AND ACCESS VESSEL AND WAS NOT A DEVICE RELATED ISSUE. THERE HAS BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AT THIS TIME.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 7119793 ↗
• InjuryMar 22, 2016Failure To Adhere Or Bond; Kinked; Failure To Adhere Or Bond; Kinked

  THE PATIENT INITIALLY IMPLANTED ON (B)(6) 2016 WITH A BIFURCATED, SUPRARENAL AORTIC EXTENSION AND A LIMB AORTIC EXTENSION. A SECONDARY INTERVENTION WAS COMPLETED TO SEAL A TYPE 1A ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT A SUPRARENAL AORTIC EXTENSION AND A COMPETITOR DEVICE TO RESOLVE THE ENDOLEAK. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 5515933 ↗

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-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-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-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-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-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
• 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-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• 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-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

…and 1 more.