AFX2 Bifurcated Endograft System BEA22-60/I16-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00818009015013), received between Sep 15, 2017 and Jul 23, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Occlusion Within Device” (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.

• InjuryJul 23, 2024Material Separation; Material Separation

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE THE PATIENT WAS EMERGENTLY TAKEN TO THE HOSPITAL DUE TO ANEURYSM RUPTURE AND A TYPE IIIA ENDOLEAK WITH JUNCTION SEPARATION WAS IDENTIFIED. THE PHYSICIAN ELECTED TO IMPLANT TWO (2) VELA INFRARENAL AORTIC EXTENSION STENT GRAFTS. THE ENDOLEAK WAS STILL OBSERVED BUT AFTER BALLOON TOUCH UP THE ENDOLEAK WAS RESOLVED. THE PATIENT IS REPORTED TO HAVE LOW BLOOD PRESSURE AFTER INTERVENTION AND IS CURRENTLY BEING MONITORED.

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 19812710 ↗
• InjuryJan 20, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AFX2 BIFURCATED DEVICE IMPLANT PROCEDURE; DEVICE WOULDN¿T ADVANCE INTO THE TIGHT AORTA. THE PHYSICIAN ELECTED TO RETRACT THE AFX2 DEVICE BACK INTO THE INTRODUCER SHEATH AND IN DOING SO THE DISTAL PART OF THE SHEATH CREATED A KINK IN THE COMPONENT. EXTRAVASATION WAS NOTICED AND THE PATIENT'S BLOOD PRESSURE DROPPED. AN OPEN REPAIR OF THE EXTERNAL ILIAC WAS PERFORMED. THE FINAL PATIENT STATUS WAS REPORTED AS DOING GOOD.

  Patient problems: Extravasation; Low Blood Pressure/ Hypotension; Vascular Dissection

  MAUDE report 16219600 ↗
• InjuryAug 16, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, AND A VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (2) TWO YEARS AFTER POST INITIAL PROCEDURE THE PATIENT WAS BROUGHT IN URGENTLY DUE TO A TYPE 3A ENDOLEAK AND ANEURYSM RUPTURE. THE PHYSICIAN ELECTED TO PERFORM A RE-INTERVENTION BY IMPLANTING A (NON-ENDOLOGIX DEVICE) GORE EXCLUDER. THE PROCEDURE WAS COMPLETED BUT THE FINAL PATIENT STATUS REMAINS UNKNOWN. THE FINAL PATIENT STATUS WAS NOT MADE AVAILABLE TO ENDOLOGIX.

  Patient problems: Failure of Implant; Rupture

  MAUDE report 12328422 ↗
• InjuryJan 3, 2019Obstruction of Flow; Obstruction of Flow

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, A COMPUTERIZED TOMOGRAPHY (CT) IDENTIFIED RIGHT LIMB OCCLUSION OF THE MAIN BODY. A SECONDARY PROCEDURE WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT TWO (2) BALLOON EXPANDABLE STENTS (NON-ENDOLOGIX) IN THE RIGHT LIMB. THE CASE APPEARED SUCCESSFUL AND THE PATIENT IS CURRENTLY DOING FINE.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 8212147 ↗
• InjurySep 20, 2017Occlusion Within Device; Occlusion Within Device

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT. ON (B)(6) 2017 THE PATIENT BEGAN EXPERIENCING PAIN IN THE LEFT LEG. ON (B)(6) 2017, THE PATIENT CAME IN EMERGENTLY WITH LEFT LEG PAIN. THE PHYSICIAN IDENTIFIED A LEFT ILIAC LIMB OCCLUSION. THE PHYSICIAN COMPLETED A THROMBECTOMY TO RESOLVE THE ISSUE. THE PATIENT IS REPORTED TO BE DOING WELL POST PROCEDURE. THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

  Patient problems: Failure of Implant; Occlusion; Pain

  MAUDE report 6878957 ↗
• InjurySep 15, 2017Collapse; Occlusion Within Device; Off-Label Use; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Collapse; Occlusion Within Device; Off-Label Use; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT TO TREAT OCCLUSIVE DISEASE AND AN AORTOILIAC DISSECTION. THE PROCEDURE WAS COMPLETED AND TWO HOURS POST IMPLANT THE PATIENT EXPERIENCED BACK PAIN, LOSS OF BILATERAL DISTAL PULSE AND COLDNESS OF THE FEET. THE PHYSICIAN COMPLETED AN ANGIOGRAM AND FOUND AN OCCLUSION IN THE AORTA. THE PHYSICIAN INSERTED A CATHETER TO BEGIN TISSUE PLASMINOGEN ACTIVATOR (TPA) THERAPY BEFORE TRANSFERRING THE PATIENT TO (B)(6) HOSPITAL. ONCE TRANSFERRED IT WAS REPORTED THE PATIENT HAD A CLOT IN THE LEFT LIMB, AN EMBOLI IN THE LEFT TIBIAL PERONEAL TRUNK AND AN EMBOLI IN THE LEFT PROFUNDA. THE PHYSICIAN COMPLETED SEVERAL TREATMENTS INCLUDING; AN OPEN THROMBECTOMY, AN INJECTION OF TPA, AND HEPARINIZED SALINE WITH NITROGLYCERIN. THE PHYSICIAN BALLOONED THE MAIN BODY AND BOTH LIMBS. A FINAL AORTOGRAM SHOWED STENT GRAFT PATENCY AND NO RESIDUAL CLOT. THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

  Patient problems: Embolism; Failure of Implant; Occlusion; Thrombus

  MAUDE report 6868619 ↗

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-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-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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-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-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-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-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.