AFX2 Bifurcated Endograft System BEA25-120/I20-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00818009014665), received between Mar 6, 2018 and Jun 5, 2026 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2026Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL ON (B)(6) 2022. ON (B)(6) 2025 A FOLLOW UP CT WAS TAKEN, REVIEWED, AND WAS DEEMED CLEAN. ON (B)(6) 2026, THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN AT AN UNKNOWN FACILITY. AN ANGIOGRAM SUBSEQUENTLY IDENTIFIED A TYPE IIIB ENDOLEAK AT THE LEVEL OF THE AORTIC BIFURCATION. PATIENT REFERRED TO AO MAURIZIANO TORINO WHERE REINTERVENTION WAS PERFORMED IMMEDIATELY. AN AFX2 BSG, AN AFX VELA INFRARENAL, AND TWO ENDURANT ILIAC LIMBS (NON-ENDOLOGIX) WERE IMPLANTED. THE PATIENT IS REPORTED AS BEING FINE WITH NO OTHER SYMPTOMS AND HAS BEEN DISCHARGED HOME.

  Patient problems: Abdominal Pain; Clinical Endoleak

  MAUDE report 25409955 ↗
• InjuryDec 9, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL AND A VELA INFRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, DURING FOLLOW UP, A TYPE 1B ENDOLEAK ON THE RIGHT COMMON ILIAC ARTERY WAS IDENTIFIED. THE PHYSICIAN ELECTED TO RELINE THE PREVIOUSLY IMPLANTED STENT GRAFTS WITH AN ALTO STENT GRAFT SYSTEM TO SUCCESSFULLY RESOLVE THIS EVENT. THE FINAL PATIENT STATUS WAS REPORTED AS DOING FINE.

  Patient problems: Clinical Endoleak

  MAUDE report 23756988 ↗
• InjuryDec 6, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2016 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AFX VELA SUPRARENAL. A COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED ON APPROXIMATELY (B)(6) 2024 IDENTIFIED AN ENDOLEAK OF INDETERMINATE ORIGIN. REPORTEDLY, THE ANGIOGRAM SCHEDULED FOR (B)(6) 2024 HAS BEEN RESCHEDULED FOR (B)(6) 2025 DUE TO PATIENT HAVING A NON-ANEURYSM RELATED MEDICAL ISSUE. PATIENT IS CURRENTLY BEING MONITORED.

  Patient problems: Clinical Endoleak

  MAUDE report 20865467 ↗
• InjuryJul 2, 2024Off-Label Use; Material Puncture/Hole; Lack of Effect; Off-Label Use; Material Puncture/Hole; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, TWO (2) VELA SUPRARENAL AORTIC EXTENSIONS, AND A VELA INFRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2020. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, DURING A FOLLOW UP CT (COMPUTED TOMOGRAPHY) SCAN, ANEURYSM ENLARGEMENT WAS DETECTED WITH A POSSIBLE ENDOLEAK (INDETERMINATE TYPE). THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH ANOTHER AFX2 BIFURCATED STENT GRAFT, TWO (2) AFX VELA INFRARENAL AORTIC EXTENSIONS, A VELA SUPRARENAL AORTIC EXTENSION AND AN OVATION IX ILIAC EXTENDER ON (B)(6) 2024 TO RESOLVE THIS EVENT. THE FINAL PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Anemia; Aneurysm; Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 19661394 ↗
• InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT AND A AFX VELA SUPRARENAL. APPROXIMATELY 2.5 YEARS POST INITIAL PROCEDURE, AN INDETERMINATE ENDOLEAK WAS DETECTED BY ULTRASOUND DURING A ROUTINE FOLLOW-UP. REPORTEDLY, A CT WILL BE PERFORMED TO DETERMINE THE TYPE OF ENDOLEAK. THE PATIENTS CURRENT STATUS HAS BEEN REPORTED AS STABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 15495828 ↗
• InjuryFeb 26, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL IMPLANT, THE PATIENT WAS IDENTIFIED WITH ANEURYSM ENLARGEMENT WITH NO VISIBLE ENDOLEAK. THE PHYSICIAN COMPLETED AN INTERVENTION AND IMPLANTED TWO (2) OVATION IX LIMB EXTENSIONS. THE PATIENT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE WELL.

  Patient problems: Aneurysm

  MAUDE report 11388404 ↗
• InjurySep 8, 2020Partial Blockage; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Partial Blockage; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, AN AFX SUPRARENAL STENT GRAFT EXTENSION, AN AFX INFRARENAL STENT GRAFT EXTENSION AND A OVATION IX EXTENDER TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF -LABEL) DUE THE USE OF AFX WITH OVATION DEVICES. APPROXIMATELY 45 DAYS POST-OPERATION, THE PATIENT PRESENTED WITH LOWER LEG NUMBNESS, DURING THE CT (COMPUTED TOMOGRAPHY) SCAN THE PHYSICIAN OBSERVED A CLOT FORMATION IN THE MID AORTIC PORTION OF THE BIFURCATED STENT GRAFT. THE PHYSICIAN ELECTED TO IMPLANTED TWO OVATION LILAC LIMBS TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS STABLE. ADDITIONAL INFORMATION: THE CLINICAL ASSESSMENT IDENTIFIED BUCKLING OF THE BIFURCATED STENT GRAFT AND SAC GROWTH OF 11.5 MM.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 10504535 ↗
• InjurySep 7, 2018Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN NOTED A TYPE 2 ENDOLEAK WHICH IS NOT A DEVICE FAILURE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7858295 ↗
• 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 AFX2 BIFURCATED STENT GRAFT, AND AFX VELA INFRARENAL. ON (B)(6) 2018, A SECONDARY PROCEDURE WAS PERFORMED FOR AN UNKNOWN REASON AND AN AFX VELA SUPRARENAL WAS IMPLANTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Information

  MAUDE report 7443812 ↗
• InjuryMar 6, 2018Hole In Material; Leak/Splash; Stretched; Improper or Incorrect Procedure or Method; Hole In Material; Leak/Splash; Stretched; Improper or Incorrect Procedure or Method

  THE INITIAL PROCEDURE WAS PERFORMED ON (B)(6) 2017. PATIENT WAS IMPLANTED WITH A VELA INFRARENAL, AFX2 BIFURCATED STENT AND AN OVATION ILIAC EXTENSION WAS IMPLANTED INSIDE THE RIGHT LIMB OF THE AFX2 BIFURCATED. ON AN UNKNOWN LATER DATE OF THE PLANNED STEPPED PROCEDURE, A NON-ENDOLOGIX GRAFT WAS IMPLANTED. ON (B)(6) 2018, A COMPUTERIZED TOMOGRAPHY REVEALED A 3B ENDOLEAK IN THE MAIN BODY OF THE AFX2 BIFURCATED STENT. ON (B)(6) 2018, THE 3B ENDOLEAK WAS RELINED WITH A NON-ENDOLOGIX STENT. THERE HAS BEEN NO PATIENT SEQUELAE REPORTED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 7318101 ↗

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

…and 1 more.