AFX Endovascular AAA System BA25-80/I13-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00818009010179), received between Jul 6, 2016 and Aug 29, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Leak/Splash” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2023Insufficient Device Problem Information; Lack of Effect; Insufficient Device Problem Information; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A VELA SUPRARENAL STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS POST-INITIAL IMPLANT AND DURING ROUTINE FOLLOW-UP, THE CT (COMPUTED TOMOGRAPHY) SCAN IDENTIFIED CAUDAL MIGRATION OF THE PROXIMAL AFX GRAFT MEASURING GREATER THAN 10MM. REFERENCE MFR. REPORT # 2031527-2021-00195. APPROXIMATELY SEVEN (7) YEARS POST-INITIAL IMPLANTATION, A FOLLOW-UP PROCEDURE CONDUCTED WITH THE PATIENT REVEALED THE EMERGENCE OF AN EXPANDING ANEURYSM. IN LIGHT OF THIS OBSERVATION, THE ATTENDING PHYSICIAN IS CONTEMPLATING THE IMPLANTATION OF AN EXTENSION. THE PATIENT'S CURRENT STATUS IS REPORTED AS DOING WELL.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17643599 ↗
• InjuryJun 4, 2019Misconnection; Deformation Due to Compressive Stress; Misconnection; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY 4.5 YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN. CT SCAN REVEALED A TYPE IIIA ENDOLEAK WITH COMPONENT SEPARATION BETWEEN THE BIFURCATED AND PROXIMAL EXTENSION DEVICES. HOWEVER, THE EXACT DATE OF EVENT IS NOT CONFIRMED. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) ADDITIONAL SUPRARENAL AFX DEVICES ON (B)(6) 2019, AND THE ENDOLEAK WAS CONFIRMED SUCCESSFULLY REPAIRED AT THE CONCLUSION OF THE PROCEDURE. THE PATIENT DID WELL DURING THE PROCEDURE AND WAS REPORTEDLY STABLE. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Pain; Rupture; Stenosis

  MAUDE report 8668420 ↗
• InjuryMar 18, 2019Material Puncture/Hole; Product Quality Problem; Use of Device Problem; Material Integrity Problem; Material Puncture/Hole; Product Quality Problem; Use of Device 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 BY CT DURING ROUTINE FOLLOW-UP. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT WHO IS REPORTEDLY IN GOOD CONDITION. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8429815 ↗
• InjuryFeb 8, 2019Loss of or Failure to Bond; Insufficient Device Problem Information; Loss of or Failure to Bond; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED CONFIRMING THAT THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING WITH AN ADDITIONAL SUPRARENAL AND ONE (1) INFRARENAL AFX DEVICES ON (B)(6) 2019.

  Patient problems: Failure of Implant

  MAUDE report 8321449 ↗
• InjuryFeb 7, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  Patient problems: Failure of Implant

  MAUDE report 8316656 ↗
• InjuryJan 5, 2018Hole In Material; Leak/Splash; Material Integrity Problem; Hole In Material; Leak/Splash; Material Integrity Problem

  ON (B)(6) 2015, THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL EXTENSION. ON (B)(6) 2017, ENDOLOGIX WAS MADE AWARE OF A TYPE 3B ENDOLEAK. THE PHYSICIAN ELECTED TO RELINE THE INITIAL DEVICE WITH OVATION DEVICES TO RESOLVE THIS LEAK. THE PATIENT WAS REPORTED IN STABLE CONDITION AND THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Stenosis

  MAUDE report 7167414 ↗
• InjuryNov 1, 2017Leak/Splash; Leak/Splash

  AN AFX BIFURCATED STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT RETURNED FOR A FOLLOW-UP WHERE PHYSICIAN OBSERVED A POTENTIAL ENDOLEAK THROUGH ANGIOGRAPHIC REVIEW. A RE-INTERVENTION IS SCHEDULED AT A LATER DATE WHERE PHYSICIAN WILL PERFORM A FULL RELINE USING AN AFX2 BIFURCATED DEVICE. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 6994835 ↗
• InjuryJul 6, 2016Hole In Material; Leak/Splash; Hole In Material; Leak/Splash

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION ON (B)(6) 2014. ON (B)(6) 2016 THE PATIENT CAME IN EMERGENTLY WITH ABDOMINAL PAIN AND COMPUTED TOMOGRAPHY (CT) SHOWED A POTENTIAL TYPE 3B ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT A NON-ENDOLOGIX STENT TO SEAL THE LEAK. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Abdominal Pain; Failure of Implant

  MAUDE report 5774157 ↗

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-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-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-0592-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• 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-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• 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-0590-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• Z-0596-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL

…and 1 more.