AFX Endovascular AAA System BA25-90/I20-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00818009012227), received between Apr 28, 2016 and Mar 19, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Hole In Material” (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.

• InjuryMar 19, 2025Migration; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT (BSG) AND AN AFX VELA SUPRARENAL AORTIC EXTENSION FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2015. IT WAS REPORTED DURING A RECENT ROUTINE FOLLOW-UP, THE ANGIOGRAM REVEALED ANEURYSM ENLARGEMENT. THE ANGIOGRAM ON (B)(6) 2025 DEMONSTRATED THAT THERE IS A MINIMAL OVERLAP BETWEEN THE AFX BSG AND AFX VELA SUPRARENAL AORTIC EXTENSION. DUE TO THROMBOSIS THERE IS NO APPARENT ENDOLEAK VISIBLE, HOWEVER THERE IS AAA ENLARGEMENT MOST LIKELY DUE TO AN INDETERMINATE ENDOLEAK. THE PHYSICIAN ELECTED TO RELINE THE ENTIRE ENDOGRAFT SYSTEM WITH THE IMPLANTATION OF AN AFX2 BSG AND AN AFX VELA SUPRARENAL AORTIC EXTENSION. THE CASE WAS COMPLETED, THERE WAS COMPLETE INCLUSION OF THE PREVIOUSLY IMPLANT STENT GRAFTS. THE PATIENT WAS STABLE POST INTERVENTION AND WAS DISCHARGED HOME ONE DAY POST INTERVENTION.

  Patient problems: Aneurysm; Clinical Endoleak; Thrombosis/Thrombus

  MAUDE report 21643287 ↗
• InjuryAug 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS INITIALLY TREATED WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCE ROOM WITH AN EVIDENT ENDOLEAK BY CT SCAN THAT THE PHYSICIAN DEFINED AS ENDOTENSION OR TYPE II ENDOLEAK. THE PATIENT IS STABLE BUT IS COMPLAINING OF ABDOMINAL PAIN. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY EXPLANTING THE AFX GRAFT ON (B)(6) 2018. IN ADDITION, THE PHYSICIAN NOTED THERE WAS MURKY FLUID AROUND THE GRAFT PRIOR TO EXPLANT, AND THE CULTURE RESULTS ARE PENDING. THE PATIENT IS SICK POST-OPERATIVELY BUT STABLE. ENDOLOGIX CONTINUES TO FOLLOW-UP WITH THE PHYSICIAN REGARDING THE STATUS OF THE EXPLANTED DEVICE.

  Patient problems: Abdominal Pain; Aneurysm; Pain

  MAUDE report 7748518 ↗
• InjuryApr 27, 2018Hole In Material; Leak/Splash; Activation, Positioning or Separation Problem; Difficult to Advance; Hole In Material; Leak/Splash; Activation, Positioning or Separation Problem; Difficult to Advance

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION. WHILE PATIENT WAS STILL IN SURGERY THE PHYSICIAN IDENTIFIED A ENDOLEAK. THE ENDOLEAK WAS BELIEVED TO BE A TYPE 1B. THE PHYSICIAN IMPLANTED TWO LIMB EXTENSIONS TO SEAL THE LEAK. THE ENDOLEAK WAS NOT RESOLVED AND NOW BELIEVED TO BE A TYPE 3A ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN INFRARENAL AORTIC EXTENSION TO RESOLVE THE LEAK. DURING IMPLANT OF THE INFRARENAL EXTENSION THE PHYSICIAN WAS NOT ABLE TO ADVANCE THE DELIVERY SYSTEM DUE TO THE TORTUOUSITY OF THE PATIENT ANATOMY. SEVERAL ATTEMPTS TO ADVANCE THE STENT INTO PLACE EXPOSED THE SHEATH WHICH WAS PULLED BACK AT THE NOSE CONE. THE DELIVERY SYSTEM WAS REMOVED AND ANOTHER DELIVERY SYSTEM WAS USED TO IMPLANT THE INFRARENAL STENT. ENDOLEAK PERSISTED AND A TYPE 3B ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL BIFURCATED STENT TO RELINE THE MAIN BODY. DURING DEPLOYMENT OF THE BIFURCATED STENT THE CONTRALATERAL WIRE BECAME CAUGHT IN THE SUPRARENAL STRUTS. ONCE THE WIRE WAS UNTANGLED THE PHYSICIAN DID NOT WANT TO RISK POSSIBLE DAMAGE TO THE WIRE AND ELECTED TO USE A NEW BIFURCATED DEVICE TO RELINE. THE RELINE RESO

  Patient problems: Blood Loss; Failure of Implant

  MAUDE report 7470505 ↗
• InjuryApr 19, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  THE PATIENT WAS IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A VEAL SUPRARENAL ON (B)(6) 2015. CONTRAST WAS OBSERVED AT A ROUTINE FOLLOW-UP CT SCAN, AT WHICH TIME A TYPE 3A ENDOLEAK WAS OBSERVED. THE PATIENT WAS ASYMPTOMATIC. A VELA INFRARENAL WAS ADDED ON (B)(6) 2016, IMMEDIATELY AFTER WHICH THE ENDOLEAK WAS ELIMINATED AND THE PATIENT RECOVERED WELL.

  Patient problems: Failure of Implant

  MAUDE report 7445914 ↗
• InjuryApr 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND VELA INFRARENAL. ON (B)(6) 2017, A SECONDARY PROCEDURE WAS PERFORMED FOR AN UNKNOWN REASON. DURING THE INTERVENTION, AN ADDITIONAL VELA INFRARENAL WAS IMPLANTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE

  Patient problems: No Information

  MAUDE report 7444249 ↗
• InjuryApr 28, 2016Hole In Material; Hole In Material

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT, A SUPRARENAL AORTIC EXTENSION, AND THREE LIMB EXTENSIONS ON (B)(6) 2016. DURING INITIAL IMPLANT OF THE BIFURCATED DEVICE THE PHYSICIAN IDENTIFIED A TYPE 3B ENDOLEAK OF THE MAIN BODY. THE PHYSICIAN IMPLANTED A SECOND BIFURCATED STENT TO SEAL THE LEAK. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 5618875 ↗

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-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-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-0593-06 · 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
• 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
• 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-0592-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• Z-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL

…and 1 more.