AFX2 Bifurcated Endograft System BEA28-110/I16-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00818009014580), received between Nov 30, 2016 and Nov 7, 2025 — classified as 1 death, 10 injuries.

The most frequently reported specific device problem is “Material Puncture/Hole” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2025Separation Problem; Separation Problem

  THE PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT SYSTEM AND AN AFX VELA SUPRARENAL EXTENSION FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2016. ON (B)(6) 2025 THE PATIENT PRESENTED TO THE HOSPITAL EMERGENCY DEPARTMENT WITH ABDOMINAL PAIN. A COMPUTED TOMOGRAPHY (CT) REVEALED THAT THERE WAS ANEURYSM ENLARGEMENT AND A TYPE IIIA ENDOLEAK BETWEEN THE VELA SUPRARENAL AND AFX2 BIFURCATED STENT GRAFT. THE PHYSICIAN REPORTED THAT THE STENT GRAFT SEPARATION WAS DUE TO DISEASE PROGRESSION, SLIGHTLY ANGLED AND ELONGATED AORTIC NECK. THE PHYSICIAN ELECTED TO IMPLANT AN AFX VELA SUPRARENAL AORTIC CUFF AND THE TYPE IIIA ENDOLEAK WAS RESOLVED. THE PATIENT IS DOING WELL.

  Patient problems: Aneurysm; Clinical Endoleak; Pain

  MAUDE report 23497802 ↗
• InjuryJul 16, 2024Off-Label Use; Material Puncture/Hole; Device-Device Incompatibility; Off-Label Use; Material Puncture/Hole; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL PROXIMAL AORTIC EXTENSION ON (B)(6) 2018. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED AAA. THE COMPUTED TOMOGRAPHY (CT) REVEALED A TYPE IIIB ENDOLEAK. THE PHYSICIAN RELINED THE STENT GRAFT WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA INFRARENAL EXTENSION AND THE TYPE IIIB ENDOLEAK WAS RESOLVED. IT WAS REPORTED THAT THE PATIENT IS STABLE.

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 19757177 ↗
• InjuryMar 26, 2024Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, EVALUATION OF A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED WHAT APPEARS TO BE A TYPE 3B ENDOLEAK AND THE ANEURYSM MEASURED 6.8 CM IN DIAMETER. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH ANOTHER AFX2 BIFURCATED STENT GRAFT AND A VELA INFRARENAL AORTIC EXTENSION TO SUCCESSFULLY RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS GOOD POST SECONDARY PROCEDURE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 18979930 ↗
• InjuryFeb 17, 2023Separation Problem; Lack of Effect; Separation Problem; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL PROXIMAL EXTENSION. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IIIA ENDOLEAK. THE PATIENT'S CURRENT CONDITION IS UNKNOWN, AND IT IS UNKNOWN IF THE PHYSICIAN PLANS TO RE-INTERVENE. ADDITIONAL INFORMATION: CLINICAL ASSESSMENT IDENTIFIED THAT THERE WAS A COMPLETE COMPONENT SEPARATION OF THE BIFURCATED STENT GRAFT AND THE PROXIMAL EXTENSION.

  Patient problems: Clinical Endoleak

  MAUDE report 16399936 ↗
• InjuryJul 7, 2020Material Puncture/Hole; Material Integrity Problem; Material Puncture/Hole; Material Integrity Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY 1.5 YEARS POST INITIAL PROCEDURE, IT WAS DISCOVERED DURING A ROUTINE FOLLOW UP IMAGING THAT THE PATIENT'S ANEURYSM SAC GREW 1CM IN 6 MONTHS. ANGIOGRAPHY IDENTIFIED A SMALL JET TYPE IIIB ENDOLEAK AT THE BIFURCATION. SUCCESSFUL RE-INTERVENTION WAS PERFORMED WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT SEALING THE TYPE IIIB ENDOLEAK. THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 10240736 ↗
• InjuryMay 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION. THREE 3 WEEKS POST INITIAL IMPLANT, OCCLUSION OF THE LEFT LIMB OF THE BIFURCATED STENT GRAFT AND NATIVE VESSEL (ILIAC) TO FEMORAL ARTERY WERE IDENTIFIED. A SURGICAL PROCEDURE AND NON - ENDOLOGIX STENT WAS IMPLANTED TO REPAIR THE LEFT COMMON FEMORAL ARTERY. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, THE ORIGINAL BIFURCATED STENT GRAFT WAS RELINED WITH ANOTHER BIFURCATED STENT GRAFT. THESE EVENTS WERE PREVIOUSLY REPORTED IN 2017 UNDER 20131527-2017-00349. NOW APPROXIMATELY TWO (2) YEARS POST RELINE, A TYPE 1B ENDOLEAK FROM THE RIGHT LIMB OF THE BIFURCATED STENT GRAFT WAS IDENTIFIED. ANOTHER INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT A LIMB STENT GRAFT EXTENSION ON THE RIGHT SIDE AND ANOTHER SUPRARENAL STENT GRAFT EXTENSION TO TREAT THIS LEAK. THE PATIENT DID WELL DURING THE PROCEDURE AND WAS DISCHARGED.

  Patient problems: Failure of Implant

  MAUDE report 8593333 ↗
• InjuryApr 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY FOUR (4) MONTHS POST INITIAL PROCEDURE, THE PHYSICIAN ELECTED TO TREAT THE PATIENT FOR AN UNKNOWN DEVICE FAILURE BY IMPLANTING A SUPRARENAL AFX AND THREE (3) INFRARENAL AFX DEVICES ON (B)(6) 2019. THERE IS LIMITED INFORMATION AVAILABLE FOR THE INITIAL REPORT TO THIS EVENT. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: No Information

  MAUDE report 8484403 ↗
• DeathMar 25, 2019Off-Label Use; Material Puncture/Hole; Improper or Incorrect Procedure or Method; Material Integrity Problem; Unintended Movement; Off-Label Use; Material Puncture/Hole; Improper or Incorrect Procedure or Method; Material Integrity Problem; Unintended Movement

  ADDITIONAL INFORMATION: AT THE COMPLETION OF THE CLINICAL ASSESSMENT, CLINICAL WAS ABLE TO FIND SUBSTANTIAL EVIDENCE TO SUPPORT THE FOLLOWING REPORTED EVENTS OF A 1A AND 3B ENDOLEAKS AND MIGRATION OF THE SUPRARENAL STENT GRAFT EXTENSION, AAA GROWTH, A RUPTURE, AN OPEN CONVERSION WITH EXPLANT AND DEATH.

  Patient problems: Aneurysm; Death; Failure of Implant; Rupture

  MAUDE report 8450379 ↗
• InjuryApr 6, 2018Failure To Adhere Or Bond; Hole In Material; Leak/Splash; Failure To Adhere Or Bond; Hole In Material; Leak/Splash

  PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED AND VELA SUPRARENAL IN 2016. ON (B)(6) 2018, WE WERE MADE AWARE THAT THIS PATIENT HAD A POSSIBLE ENDOLEAK TYPE III (NOT SPECIFIED). THERE WAS NO SAC ENLARGEMENT AND THE PATIENT IS REPORTED TO BE DOING WELL. PATIENT WILL UNDERGO AN ANGIO AND POSSIBLE RELINE. THERE HAS BEEN NO ADDITIONAL PATIENT SEQUALAE REPORTED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 7403503 ↗
• InjuryNov 1, 2017Difficult to Insert; Difficult to Insert

  AN AFX2 BIFURCATED STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DURING THE IMPLANT PROCEDURE, IT WAS OBSERVED THAT THE YELLOW SLEEVE OF THE 035 WIRE WAS HAVING EXTREME DIFFICULTY IN PASSING THROUGH THE 7F SHEATH. IT WAS ALSO DIFFICULT TO LOAD THE AFX2 DEVICE INTO THE SHEATH. EVENTUALLY THE SHEATH BUCKLED AND BOTH THE SHEATH AND DEVICE WERE PULLED OUT AND EXCHANGED FOR NEW DEVICES. UPON CLINICAL REVIEW OF THE REPORTED EVENT, IT WAS DISCOVERED THAT THE PATIENT HAD A LEFT COMMON ILIAC DISSECTION DURING THE PROCEDURE. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Intimal Dissection

  MAUDE report 6993678 ↗
• InjuryNov 30, 2016Partial Blockage; Adverse Event Without Identified Device or Use Problem; Partial Blockage; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2016 WITH A BIFURCATED STENT, AN INFRARENAL AORTIC EXTENSION, AND A SUPRARENAL AORTIC EXTENSION. ON (B)(6) 2016 A FOLLOW UP SHOWED THE PATIENT HAD A THROMBUS MIDWAY THROUGH THE GRAFT. THE PHYSICIAN IS GOING TO MONITOR, A SECONDARY INTERVENTION HAS NOT BEEN SCHEDULED OR PLANNED. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Anemia; Blood Loss; Renal Failure; Stenosis; Thrombus

  MAUDE report 6134834 ↗

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-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-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-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• 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-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
• 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-0596-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL
• 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-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.