AFX Endovascular AAA System BA25-110/I20-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818009012234), received between Oct 5, 2017 and May 13, 2019 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 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 THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN. A TYPE IIIB ENDOLEAK WAS IDENTIFIED BY A COMPUTERIZED TOMOGRAPHY (CT) SCAN. THE PATIENT WAS SUCCESSFULLY RELINED WITH A BIFURCATED AFX2 DEVICE ON (B)(6) 2019. HOWEVER, THE PATIENT CONTINUED TO EXPERIENCE ABDOMINAL PAIN FOUR (4) HOURS POST SECONDARY IMPLANT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. ENDOLOGIX WILL CONTINUE TO OBTAIN AN UPDATE ON THE PATIENTS STATUS.

  Patient problems: Failure of Implant; Rupture

  MAUDE report 8605904 ↗
• InjuryDec 20, 2017Hole In Material; Leak/Splash; Hole In Material; Leak/Splash

  PATIENT WAS INITIALLY IMPLANTED IN 2016 WITH ONE BIFURCATED, ONE SUPRARENAL, TWO INFRARENAL, AND TWO LIMBS. IT WAS REPORTED ON (B)(6) 2017 THAT THE PATIENT HAD A SECONDARY AT AN UNKNOWN DATE. IT DURING THE CLINICAL EVALUATION OF (B)(4) (REPORT # 2031527-2017-00511) IT WAS DISCOVERED THAT ON (B)(6) 2017, THE PATIENT PRESENTED WITH AN ANEURYSM GROWTH, CUFF BUCKLING, STENT MIGRATION, AND ENDOLEAK TYPE IIB OF THE MAIN BODY. PATIENT WAS RELINED ON (B)(6) 2015 AND THE ISSUES WERE SUCCESSFULLY RESOLVED. THERE WAS NO ADDITIONAL PATIENT SEQUALAE REPORTED FOR THIS EVENT.

  Patient problems: Failure of Implant; Stenosis

  MAUDE report 7133987 ↗
• InjuryOct 5, 2017Leak/Splash; Leak/Splash

  PATIENT WAS INITIALLY TREATED IN 2013 FOR AN EMERGENT RUPTURE. AT AN UNKNOWN DATE, THE PATIENT RETURNED WITH AN ANEURYSM GROWTH AND TWO BRIDGES WERE IMPLANTED. AT A LATER UNKNOWN DATE, THE PATIENT WAS TREATED AGAIN FOR AN ANEURYSM GROWTH WITH A MEDTRONIC DEVICE. ON (B)(6) 2016 THE PATIENT UNDERWENT A COMPLETE RELINE WITH AFX DEVICES. THE CT PERFORMED SHOWED CONTINUED ANEURYSM GROWTH AND THE PHYSICIAN NOTED A POSSIBLE ENDOLEAK TYPE II. A RE-INTERVENTION HAS NOT BEEN SCHEDULED AT THIS TIME HOWEVER, THE PHYSICIAN PLANS TO COIL OFF THE IMA, THROMBIN AND BIOGEL. PATIENT CONDITION IS ASYMPTOMATIC.

  Patient problems: Aneurysm

  MAUDE report 6915980 ↗

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-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-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-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• Z-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
• 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
• 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-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL

…and 1 more.