AFX Endovascular AAA System A25-25/C95Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818009010315), received between Oct 5, 2017 and Dec 27, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Leak/Splash” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2017Failure To Adhere Or Bond; Leak/Splash; Occlusion Within Device; Deformation Due to Compressive Stress; Failure To Adhere Or Bond; Leak/Splash; Occlusion Within Device; Deformation Due to Compressive Stress

  ON (B)(6) 2017, ENDOLOGIX AFX DEVICES WERE IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2017, A TYPE 1A ENDOLEAK DUE TO BUCKLING OF THE PROXIMAL EXTENSION WAS DISCOVERED. ALSO THROMBOTIC OCCLUSION WAS CONFIRMED IN THE INNER LUMEN. ON (B)(6) 2017, A TOTAL OF FOUR (4) NON-ENDOLOGIX STENTS WAS IMPLANTED AND THE ENDOLOGIX STENT WAS EXPLANTED. THE OPERATION WAS COMPLETED WITHOUT ENDOLEAK. NO ADDITIONAL PATIENT SEQUELAE HAS BEEN REPORTED.

  Patient problems: Failure of Implant; Occlusion; Thrombosis; Thrombus

  MAUDE report 7149706 ↗
• InjuryOct 5, 2017Loss of or Failure to Bond; Leak/Splash; Folded; Loss of or Failure to Bond; Leak/Splash; Folded

  AN AFX2 BIFURCATED STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 3 WEEKS POST INDEX PROCEDURE, THE PATIENT RETURNED WITH INTERMITTENT FEELING OF NUMBNESS ON THE RIGHT LEG. A CT REVEALED THAT THERE WAS INFOLDING OF THE PROXIMAL EXTENSION AND A THROMBOEMBOLIC EVENT ON THE ENTIRE LENGTH OF THE RIGHT COMMON ILIAC. A RE-INTERVENTION WAS PERFORMED APPROXIMATELY ONE MONTH POST INDEX PROCEDURE WHERE PHYSICIAN IMPLANTED SIX EXCLUDER AORTIC EXTENSIONS FROM THE DISTAL PORTION OF THE INFRARENAL EXTENSION UP TO JUST BELOW THE RENAL ARTERY. THE THROMBUS IN THE RIGHT ILIAC ARTERY WAS REMOVED AND A STENT WAS IMPLANTED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aortic Dissection; Occlusion; Thrombus

  MAUDE report 6914819 ↗

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-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-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-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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-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-0596-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL
• 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-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• 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-0592-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• 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.