AFX Endovascular AAA System BA22-60/I16-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00818009010193), received between Aug 12, 2016 and Aug 30, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE PLANNING: (B)(6) 2020, (B)(6) 2021 CT SCAN: (B)(6) 2021

  Patient problems: Failure of Implant

  MAUDE report 12388277 ↗
• InjuryJan 25, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL AND A VELA INFARENAL ENDOGRAFT TO TREAT A ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (4) FOUR YEARS POST INITIAL PROCEDURE, A TYPE 3A ENDOLEAK WITH DEVICE SEPARATION CAUSING A RUPTURE AAA WAS IDENTIFIED. THE PATIENT WAS BEING TRANSFERRED TO A DIFFERENT HOSPITAL FOR TREATMENT HOWEVER WENT INTO CARDIAC ARREST. PER PATIENT¿S FAMILY REQUEST NO ADDITIONAL TREATMENT WAS PERFORMED AND THE PATIENT EXPIRED ON (B)(6) 2020.

  Patient problems: Cardiopulmonary Arrest; Death; Failure of Implant; Rupture

  MAUDE report 11228196 ↗
• InjuryOct 17, 2017Difficult to Remove; Difficult to Remove

  AN AFX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. UPON RETRACTION OF THE CONTRALATERAL WIRE OF THE AFX SYSTEM, THE PHYSICIAN WAS MET WITH RESISTANCE. THE LIMB CAP WAS OBSERVED TO BE HITTING THE SHEATH, SO A SHEATH DILATOR WAS INSERTED OVER THE WIRE, AND THE PHYSICIAN ATTEMPTED TO PULL BACK AND REMOVE THE LIMB CAP. THIS LEAD TO THE CONTRALATERAL SHEATH BEING CRUSHED. A HEMATOMA FORMED ON THE ACCESS SITE DUE TO THIS. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Hematoma

  MAUDE report 6955516 ↗
• InjuryAug 12, 2016Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE ON (B)(6) 2016, PHYSICIAN NOTED THE ANEURYSMAL RIGHT COMMON ILIAC ARTERY HAD MODERATE CALCIFICATION AND MODERATE TORTUOSITY AND THE LEFT EXTERNAL ILIAC ARTERY WAS NARROW WITH CALCIFICATION. DURING DEPLOYMENT OF THE BIFURCATED DEVICE, IT WAS DIFFICULT TO DEPLOY THE CONTRALATERAL SIDE DUE TO PATIENT ANATOMY. AFTER DEPLOYMENT, PROCEDURE WAS COMPLETED, BUT PHYSICIAN NOTED THAT THE LEG WAS PULSELESS AND THAT BLOOD CIRCULATION WAS NOT MADE AT THE PERIPHERY. THIS WAS DUE TO A DISSECTION IN THE LEFT EXTERNAL ILIAC ARTERY THAT WAS RESOLVED BY IMPLANTING A NON-ENDOLOGIX STENT. PHYSICIAN ELECTED TO ALSO IMPLANT A LIMB EXTENSION TO BETTER SEAL THE LEFT COMMON ILIAC ARTERY, WHICH WAS ALSO DIFFICULT TO DEPLOY DUE TO DEVICE BEING CAUGHT BY AN EDGE OF THE CONTRALATERAL LIMB OF THE BIFURCATED DEVICE. PHYSICIAN WAS ABLE TO DEPLOY THE LIMB EXTENSION AND COMPLETE THE PROCEDURE. PATIENT IS IN STABLE CONDITION.

  Patient problems: Aortic Dissection

  MAUDE report 5871945 ↗

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-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-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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-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-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-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
• 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.