AFX2 Bifurcated Endograft System BEA22-80/I20-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00818009014955), received between Dec 11, 2019 and May 5, 2026 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Off-Label Use; Separation Problem

  THE PATIENT UNDERWENT IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT (BSG), AN AFX VELA SUPRARENAL EXTENSION, AND A NON ENDOLOGIX EXCLUDER ILIAC LEG FOR TREATMENT OF A RIGHT COMMON ILIAC ARTERY ANEURYSM (CIAA) AND AN ABDOMINAL AORTIC ANEURYSM (AAA). DURING THE INITIAL PROCEDURE, THE RIGHT INTERNAL ILIAC ARTERY WAS EMBOLIZED, AND AN EXCLUDER LEG WAS DEPLOYED FROM THE RIGHT COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY. THE AFX2 BSG WAS DEPLOYED VIA A RIGHT FEMORAL ARTERY APPROACH. AN AFX VELA SUPRARENAL EXTENSION WAS SUBSEQUENTLY PLACED, ALIGNED WITH THE LEFT RENAL ARTERY, FOLLOWED BY COMPLETE TOUCH UP MOLDING. FINAL ANGIOGRAPHY IDENTIFIED A TYPE II ENDOLEAK; HOWEVER, THE PROCEDURE WAS CONCLUDED WITH A PLAN FOR ROUTINE SURVEILLANCE. APPROXIMATELY EIGHT YEARS FOLLOWING THE INDEX PROCEDURE, IT WAS REPORTED THAT THE OVERLAP BETWEEN THE AFX2 BSG AND THE AFX VELA SUPRARENAL EXTENSION HAD DECREASED TO APPROXIMATELY ONE STENT LENGTH, RESULTING IN A TYPE IIIA ENDOLEAK AND ANEURYSM SAC ENLARGEMENT TO 80 MM. ON (B)(6) 2026, AN ADDITIONAL EVAR PROCEDURE WAS PERFORMED. INTRAOPERATIVE ANGIOGRAPHY OF THE JUNCTION BETWEEN THE AFX2 BIFURCATED STENT GRAFT AND THE AFX VELA CUFF SHOWED NO EVIDENCE

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 25085442 ↗
• InjuryDec 3, 2025Off-Label Use; Deformation Due to Compressive Stress; Off-Label Use; Deformation Due to Compressive Stress

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2020. THE LEFT INTERNAL ILIAC ARTERY (IIA) WAS EMBOLIZED AND A GORE EXCLUDER (NON-ENDOLOGIX) LEG WAS IMPLANTED IN THE LEFT COMMON ILIAC ARTERY (CIA), AFTER WHICH AN AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL AND A VELA INFRARENAL WERE IMPLANTED. APPROXIMATELY FIVE AND A HALF (5.5) YEARS POST INITIAL PROCEDURE, DURING A FOLLOW-UP ON AN UNKNOWN DATE, IT WAS REPORTED THAT THERE WAS AN INDETERMINATE TYPE ENDOLEAK AND SAC ENLARGEMENT WERE OBSERVED. THE PHYSICIAN ELECTED TO TREAT THE PATIENT AND AN ADDITIONAL INTERVENTION WAS PERFORMED. AFTER EMBOLIZING THE RIGHT IIA, AN OVATION IX ILIAC LIMB WAS IMPLANTED FROM THE RIGHT CIA TO THE EXTERNAL ILIAC ARTERY (EIA) VIA A LEFT APPROACH BY CROSSING OVER THE AFX2 BIFURCATED STENT GRAFT WITH A GUIDEWIRE. THE DELIVERY SYSTEM WAS THEN RETRIEVED WITHOUT ANY ISSUES. AN OVATION IX ILIAC EXTENSION WAS IMPLANTED VIA A LEFT APPROACH USING A 14 FR DRYSEAL (NON-ENDOLIGIX) SHEATH, OVERLAPPING THE DISTAL END OF THE PREVIOUSLY PLACED OVATION IX ILIAC LIMB BY HALF THE GRAFT LENGTH. DURING RETRIEVAL OF THIS DELIVERY SYSTEM, THE TIP INTERFERED WITH THE AFX2 BIFURCATED STENT, CAUSING DIFF

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 23706892 ↗
• InjuryMar 21, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, THE PHYSICIAN ELECTED TO EXPLANT THE STENT GRAFT DUE TO SAC ENLARGEMENT WITH AN UNKNOWN REASON. THE BIFURCATED STENT GRAFT AND PART OF THE AORTIC EXTENSION WERE EXPLANTED. A Y-SHAPED GRAFT WAS SURGICALLY SUTURED TO THE REMAINDER OF THE AORTIC EXTENSION THAT WAS LEFT IN PLACE. THE PHYSICIAN DETERMINED THERE WAS A TYPE V ENDOLEAK. THE FINAL PATIENT STATUS WAS NOT REPORTED. THE EXPLANTED BIFURCATED STENT GRAFT IS AVAILABLE FOR RETURN/EVALUATION.

  Patient problems: Aneurysm

  MAUDE report 16586878 ↗
• InjuryDec 8, 2022Insufficient Device Problem Information; Lack of Effect; Insufficient Device Problem Information; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR AND A HALF (4.5) YEARS POST INITIAL PROCEDURE, A COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED ANEURYSM ENLARGEMENT, HOWEVER, THE CT DID NOT SHOW ANY ENDOLEAK. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 15946919 ↗
• InjuryDec 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). REPORTEDLY, THE PATIENT HAD PRE-EXISTING OCCLUSION OF THE RIGHT INFERIOR ILIAC ARTERY AND THE LEFT COMMON ILIAC ARTERY WAS 8 MM WITH SIGNIFICANT CURVE (CAUTIONARY PRODUCT USE). APPROXIMATELY TEN (10) MONTHS POST INITIAL IMPLANT, THE PATIENT PRESENTED WITH LEG PAIN. COMPUTED TOMOGRAPHY SCAN IDENTIFIED LEFT COMMON ILIAC ARTERY OCCLUSION. THE PHYSICIAN PLANS TO EXPLANT THE DEVICE AND REPLACE THE VESSEL WITH AN AORTIC GRAFT BUT SURGERY HAS NOT BEEN SCHEDULED. PATIENT STATUS WAS NOT REPORTED. ADDITIONAL INFORMATION: THE PATIENT¿S LEFT LEG PAIN IMPROVED WITHOUT A RE-INTERVENTION (IT IS UNKNOWN WHEN IT WAS RESOLVED). THEREFORE, IT HAS BEEN DECIDED NOT TO PERFORM A RE-INTERVENTION AND TO MONITOR THE PATIENT.

  Patient problems: Occlusion

  MAUDE report 11058360 ↗
• InjuryMay 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND AN AFX LIMB STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, SAC EXPANSION OF AN UNKNOWN DIAMETER WAS IDENTIFIED DURING A ROUTINE COMPUTERIZED TOMOGRAPHY SCAN. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC. EXPLANT AND OF THE DEVICE AND OPEN REPAIR SURGERY PLACING A TUBE GRAFT WAS PERFORMED. THE PROCEDURE WAS SUCCESSFUL, AND THE PATIENT DID WELL.

  Patient problems: Aneurysm

  MAUDE report 10096292 ↗
• InjuryMar 2, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DURING THE INITIAL IMPLANTATION OF THE AN AFX2 BIFURCATED STENT GRAFT, AN INTRAOPERATIVE 3B ENDOLEAK AND DEPLOYMENT ISSUE WAS REPORTED. THE PATIENT HAD COILING AND A NON- ENDOLOGIX (GORE/ EXCLUDER LEG) STENT IMPLANTED IN THE RIGHT COMMON ILIAC ARTERY FIRST. THIS IS OUTSIDE THE OUTSIDE THE INDICATIONS OF USE DUE TO THE USE OF NON- ENDOLOGIX DEVICES. THE AFX2 BIFURCATED STENT GRAFT WAS THEN IMPLANTED USING THE LEFT ACCESS. WHEN DEPLOYING THE CONTRALATERAL LIMB OF THE BIFURCATED STENT GRAFT IT APPEARS THAT IT DID NOT FULLY EXPAND. AN ANGIOGRAM AFTER BALLOON TOUCH-UP ON BOTH THE AFX2 BIFURCATED STENT GRAFT AND NON-ENDOLOGIX (EXCLUDER LEG) STENT SHOWED AN ENDOLEAK. AN AFX LIMB STENT GRAFT WAS ADDED AND ANOTHER ANGIOGRAPHY WAS PERFORMED. AS THE VOLUME OF ENDOLEAK WAS DECREASED, THE PROCEDURE WAS COMPLETED.

  Patient problems: Failure of Implant

  MAUDE report 9777768 ↗
• InjuryDec 11, 2019Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Improper or Incorrect Procedure or Method; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A NON - ENDOLOGIX STENT (GORE EXCLUDER LEG)TO TREAT AN ILIAC ARTERY ANEURYSM. THIS CASE IS OUTSIDE THE INDICATIONS OF USE (OFF -LABEL). A POSSIBLE INTRAOPERATIVE TYPE 3B WAS REPORTED AT THE END OF THE PROCEDURE. APPROXIMATELY FOUR DAYS LATER, IT WAS REPORTED THAT THE ENDOLEAK HAD RESOLVED ITSELF AS THERE IS NO ENDOLEAK PRESENT. THE PATIENT WILL BE MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 9453386 ↗

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-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-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-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-0593-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• 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-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
• 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-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• Z-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL

…and 1 more.