AFX Endovascular AAA System A25-25/C75-O20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818009010353), received between Sep 21, 2017 and Aug 30, 2021 — classified as 2 injuries.

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

• InjuryAug 30, 2021Migration; Migration

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AFX BIFURCATED STENT GRAFT AND AN AFX SUPRARENAL. AT A ROUTINE FOLLOW-UP ON AN UNKNOWN DATE, A TYPE IA ENDOLEAK WAS IDENTIFIED AND THE AFX SUPRARENAL HAD MIGRATED DISTALLY. APPROXIMATELY FOUR AND A HALF (4.5) YEARS POST INITIAL PROCEDURE, REINTERVENTION WAS COMPLETED BY IMPLANTING AN AFX VELA SUPRARENAL, BUT THE TYPE IA ENDOLEAK WAS NOT SEALED. A MEDTRONIC (NON-ENDOLOGIX) ENDURANT CUFF WAS THEN DEPLOYED. THE PROCEDURE WAS COMPLETED WITH A GAP OBSERVED BETWEEN THE AFX BIFURCATED STENT GRAFT AND THE DISTAL AREA OF THE AFX VELA SUPRARENAL, HOWEVER NO ENDOLEAKS WERE PRESENT. PATIENT STATUS WAS NOT REPORTED. NOTE: AS THE EXACT DATE OF EVENT IS UNKNOWN, THE BEST ESTIMATE WAS USED, WHICH IS THE REINTERVENTION DATE TO THIS EVENT.

  Patient problems: Failure of Implant

  MAUDE report 12385022 ↗
• InjurySep 21, 2017Leak/Splash; Leak/Splash

  AN AFX BIFURCATED STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE INITIAL IMPLANT WAS COMPLETED WITH A 1 BIFURCATED STENT GRAFT AND 2 CUFFS. THERE WAS NO BALLOONING DONE AT THE END OF THE PROCEDURE AND THERE WAS REPORTEDLY BAD OVERLAP BETWEEN THE GRAFTS DUE TO CALCIFICATIONS IN THE NECK. THIS RESULTED IN A TYPE IA ENDOLEAK AND A TYPE IIIA ENDOLEAK BETWEEN THE COMPONENTS. THE PHYSICIAN IS PLANNING TO RE-INTERVENE AT A LATER A DATE. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 6884381 ↗

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-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-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-0589-06 · 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-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• 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-0593-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL

…and 1 more.