AFX Endovascular AAA System BA25-60/I16-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00818009010209), received between Jan 11, 2017 and Oct 15, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2024Off-Label Use; Lack of Effect; Off-Label Use; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2016 WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX LIMB STENT GRAFT DISTAL EXTENSION. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IB ENDOLEAK (OF THE RIGHT COMMON ILIAC). THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY EXTENDING THE RIGHT LIMB GRAFT; ONE (1) ADDITIONAL AFX LIMB STENT GRAFT WAS IMPLANTED ON 07 AUGUST 2023. REPORTEDLY, THE PATIENT WAS IN STABLE CONDITION WITH NO ADDITIONAL PATIENT SEQUELAE. (REPORTED UNDER MFR# 2031527-2023-00024). NOW APPROXIMATELY ONE (1) YEAR POST-REINTERVENTION ON (B)(6) 2024, ROUTINE FOLLOW-UP SUSPECTED A TYPE III ENDOLEAK. AN ANGIOGRAM WAS SCHEDULED FOR (B)(6) 2024, HOWEVER IT HAS BEEN POSTPONED UNTIL (B)(6) 2024 FOR UNKNOWN REASON. THE PATIENT STATUS WAS REPORTED AS ALIVE AND WELL.

  Patient problems: Clinical Endoleak

  MAUDE report 20451784 ↗
• InjuryFeb 8, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX LIMB STENT GRAFT DISTAL EXTENSION. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IB ENDOLEAK (OF THE RIGHT COMMON ILIAC). THE PHYSICIAN PLANS TO RE-INTERVENE, BUT THE PATIENT'S CURRENT CONDITION IS UNKNOWN. ADDITIONAL INFORMATION: THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY EXTENDING THE RIGHT LIMB GRAFT; ONE (1) ADDITIONAL AFX LIMB STENT GRAFT WAS IMPLANTED ON (B)(6) 2023. REPORTEDLY, THE PATIENT WAS IN STABLE CONDITION WITH NO ADDITIONAL PATIENT SEQUELAE.

  Patient problems: Clinical Endoleak

  MAUDE report 16322320 ↗
• InjuryMar 24, 2021Use of Device Problem; Insufficient Device Problem Information; Separation Problem; Use of Device Problem; Insufficient Device Problem Information; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND TWO (2) ILIAC LIMB STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, A TYPE 3A ENDOLEAK WAS IDENTIFIED. IT WAS REPORTED THAT THERE WAS SEPARATION BETWEEN THE BIFURCATED STENT GRAFT AND THE ILIAC LIMB STENT GRAFT ON BOTH SIDES. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT THREE (3) ILIAC LIMB STENT GRAFTS TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS STABLE POST THE SECONDARY PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 11566415 ↗
• InjuryJan 19, 2017Loss of or Failure to Bond; Detachment Of Device Component; Difficult or Delayed Positioning; Positioning Failure; Improper or Incorrect Procedure or Method; Loss of or Failure to Bond; Detachment Of Device Component; Difficult or Delayed Positioning; Positioning Failure; Improper or Incorrect Procedure or Method

  DURING THE INITIAL DEPLOYMENT OF A BIFURCATED STENT GRAFT ON (B)(6) 2016 THE PHYSICIAN HAD DIFFICULTY DEPLOYING THE STENT. THE PHYSICIAN PERFORMED TROUBLESHOOTING STEPS AND STILL WAS NOT ABLE TO COMPLETE THE INITIAL IMPLANT OF THE BIFURCATED STENT. WHEN ATTEMPTING TO DEPLOY THE IPSI LATERAL LIMB THE INNER CORE OF THE DEVICE BROKE AND DETACHED FROM THE DELIVERY SYSTEM. THE PATIENT HAD BLOOD LOSS AND DAMAGE TO THE AORTIC VESSEL WALL. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICE AND COMPLETED AN OPEN REPAIR OF THE ANEURYSM. THE PROCEDURE WAS COMPLETED AND THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

  Patient problems: Blood Loss; Failure of Implant; Hematoma; Rupture

  MAUDE report 6265433 ↗
• InjuryJan 19, 2017Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED, A CLINICAL EVALUATION FOUND THE PATIENT RETURNED TO THE HOSPITAL TWO TIMES ON (B)(6) 2015 AND (B)(6) 2015, POST INITIAL PROCEDURE FOR BLEEDING FROM THE ACCESS SITE. PATIENT WAS TREATED AND RELEASED FROM THE HOSPITAL.

  Patient problems: Aneurysm

  MAUDE report 6265424 ↗
• InjuryJan 11, 2017Failure To Adhere Or Bond; Difficult or Delayed Positioning; Leak/Splash; Failure To Adhere Or Bond; Difficult or Delayed Positioning; Leak/Splash

  PATIENT WAS BEING TREATED FOR A RIGHT COMMON ILIAC ARTERY (RCIA) ANEURYSM AND WAS INITIALLY IMPLANTED WITH A NON-ENDOLOGIX STENT IN THE RCIA. AFTER THE PLACEMENT OF THE NON-ENDOLOGIX STENT THE PHYSICIAN DEPLOYED THE AFX BIFURCATED STENT. DURING THE DEPLOYMENT OF THE BIFURCATED STENT THE PHYSICIAN HAD DIFFICULTY ADVANCING THE GUIDE WIRE THROUGH THE LUMEN OF THE SURE PASS WIRE. THE PHYSICIAN HAD TO CUT THE PERIPHERAL END OF THE SURE PASS WIRE AND THE GUIDE WIRE WAS INSERTED WITHOUT DIFFICULTY. ONCE THE BIFURCATED DEVICE WAS DEPLOYED THE PHYSICIAN COMPLETED A BALLOON TOUCH UP. THE FINAL RUN ANGIOGRAM IDENTIFIED A RUPTURED LEFT COMMON ILIAC ARTERY (LCIA). THE PHYSICIAN IMPLANTED TWO ADDITIONAL NON-ENDOLOGIX LIMB EXTENSIONS TO REPAIR THE RUPTURE. A TYPE 1B ENDOLEAK REMAINED FOLLOWING THE REPAIR AND THE PHYSICIAN ELECTED TO COMPLETE AN OPEN REPAIR OF THE LCIA TO SEAL THE ENDOLEAK. THE PROCEDURE WAS SUCCESSFUL AND THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

  Patient problems: Aneurysm; Failure of Implant; Rupture

  MAUDE report 6244147 ↗

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-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-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-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-0596-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL
• 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-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
• 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-0593-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• 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.