AFX2 Bifurcated Endograft System BEA22-70/I20-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00818009015105), received between Nov 1, 2018 and Jan 7, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2025Off-Label Use; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. AN ANGIOGRAM SHOWED AN ENDOLEAK AT THE JUNCTION OF THE AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL THAT THE PHYSICIAN DETERMINED WAS EITHER A TYPE IIIA OR A TYPE IIIB ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT A GORE CUFF (NON-ENDOLOGIX) TO OVERLAP THE DISTAL HALF OF THE AFX VELA SUPRARENAL. THE FINAL ANGIOGRAPHY SHOWED THAT THE ENDOLEAK HAD DISAPPEARED, AND THE PROCEDURE WAS COMPLETED. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A RAPIDLY GROWING AORTIC ANEURYSM DIAMETER AND SYMPTOMS OF ANEMIA. THE PATIENT HAD A REVERSE TAPER NECK THAT WAS SIGNIFICANTLY BENDING BACKWARD AS WELL AS THE ANEMIA PRIOR TO THE INITIAL TREATMENT. THE PHYSICIAN HAS DECIDED THAT ADDITIONAL TREATMENT IS REQUIRED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 21095369 ↗
• InjuryJun 21, 2024Improper or Incorrect Procedure or Method; Lack of Effect; Improper or Incorrect Procedure or Method; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT ON (B)(6) 2022. IT WAS REPORTED THAT THE ROUTINE FOLLOW-UP ON (B)(6) 2024, IDENTIFIED A TYPE IA ENDOLEAK. REINTERVENTION IS IN THE PIPELINE FOR (B)(6) 2024. THE PATIENT IS ASYMPTOMATIC.

  Patient problems: Clinical Endoleak

  MAUDE report 19579745 ↗
• InjuryJan 2, 2024Material Puncture/Hole; Device-Device Incompatibility; Material Puncture/Hole; Device-Device Incompatibility

  THE PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) THROUGH THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT AND A NON-ENDOLOGIX GORE EXCLUDER LEG. THIS INITIAL PROCEDURE FALLS OUTSIDE THE INDICATED USE (OFF-LABEL) DUE TO THE UTILIZATION OF ADJUNCTIVE DEVICES INCOMPATIBLE WITH THE AFX2 SYSTEM, AS PER THE INSTRUCTIONS FOR USE (IFU). APPROXIMATELY TEN (10) DAYS AFTER THE INITIAL PROCEDURE, THE PATIENT PRESENTED AT THE HOSPITAL WITH VASCULAR INSUFFICIENCY IN THE LOWER LIMB. A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THE AFX2 WAS NOT CONFORMING TO THE AORTA'S TORTUOSITY, RESULTING IN THE COLLAPSE OF THE STENT GRAFT AND A NARROWING OF THE INNER LUMEN. THE RIGHT DORSAL ARTERY BECAME PALPABLE, PROMPTING THE DECISION TO MONITOR THE PATIENT WITH ANTICOAGULANT THERAPY. UPON A FOLLOW-UP CT SCAN, IT WAS OBSERVED THAT THE PREVIOUSLY COLLAPSED PORTION HAD EXPANDED, ALONG WITH THE RIGHT DORSAL ARTERY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. HOWEVER, APPROXIMATELY TWO (2) WEEKS LATER, THE PATIENT WAS READMITTED DUE TO RECURRING SYMPTOMS. A RE-INTERVENTION WAS PERFORMED, LEADING TO THE EXPLANT OF THE AFX2 DEVICE AND AN IMPLANTATION OF A (NON-ENDOLOGIX) GORE Y-SHAPED AR

  Patient problems: Clinical Endoleak

  MAUDE report 18428668 ↗
• InjuryMay 31, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT AND AFX VELA SUPRARENAL PROXIMAL EXTENSION. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE 1B ENDOLEAK AND A TYPE 2 ENDOLEAK (NON-DEVICE-RELATED). THE PATIENT IS CURRENTLY BEING MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 14554449 ↗
• InjuryJan 10, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2016. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE II AND POSSIBLE IB ENDOLEAKS. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING WITH AN AFX2 BIFURCATED DEVICE, AN AFX SUPRARENAL, AND TWO (2) OVATION IX EXTENDERS ON (B)(6) 2020. REFERENCE MFR. REPORT # 2031527-2020-00106 FOR THIS PREVIOUSLY REPORTED EVENT. AFTER APPROXIMATELY TWO (2) YEARS POST-SECONDARY PROCEDURE, THE PATIENT PRESENTED WITH AN ANEURYSM ENLARGEMENT. THE PATIENT IS CURRENTLY BEING MONITORED.

  Patient problems: Aneurysm

  MAUDE report 13216201 ↗
• InjuryApr 28, 2020Insufficient Device Problem Information; Separation Problem; Insufficient Device Problem Information; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 BIFURCATED STENT GRAFT AND TWO (2) AFX VELA SUPRARENAL EXTENSIONS. THE FIRST AFX VELA WAS POSITIONED LOWER THAN INTENDED; THEREFORE, THE SECOND WAS REQUIRED. THE INITIAL PROCEDURAL INFORMATION IS NOT AVAILABLE. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH ABDOMINAL PAIN. A COMPUTERIZED TOMOGRAPHY AND A DIGITAL SUBTRACTION ANGIOGRAPHY WERE PERFORMED. EACH IDENTIFIED A TYPE IIIA ENDOLEAK BETWEEN AFX2 AND DISTAL AFX VELA. THE TYPE IIIA WAS SUCCESSFULLY SEALED WITH A NON-ENDOLOGIX (EXCLUDER) AORTIC CUFF. ADDITIONALLY, THE PATIENT¿S ABDOMINAL PAIN RESIDED. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION POST RE-INTERVENTION. SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLE SUGGEST AN AORTIC RUPTURE OCCURRED THAT WERE NOT INCLUDED IN THE EVENT AS REPORTED.

  Patient problems: Failure of Implant; Pain; Rupture

  MAUDE report 10005596 ↗
• InjuryNov 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH A BIFURCATED STENT GRAFTS AND A NON - ENDOLOGIX CUFF (ENDURANT) TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS CASE IS CONSIDERED OFF - LABEL DUE TO THE USE OF THE NON- ENDOLEAK STENT. EIGHT (8) DAYS POST IMPLANT, THE PATIENT AORTA RUPTURED AROUND THE NON - ENDOLOGIX CUFF (ENDURANT). AN EMERGENCY OPERATION WAS PERFORMED BUT THE PATIENT EXPIRED. THE EXACT CAUSE OF DEATH IS UNKNOWN HOWEVER IT WAS REPORTED BY THE PHYSICIAN THAT THE POSSIBLE CAUSE COULD BE DISSECTION AROUND THE NON - ENDOLOGIX CUFF (ENDURANT) CAUSING THE RUPTURE.

  Patient problems: Death; Failure of Implant; Rupture

  MAUDE report 8030597 ↗

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-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-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-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-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
• 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-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-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

…and 1 more.