AFX Endovascular AAA System BA22-80/I16-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00818009010124), received between Dec 6, 2016 and Jul 28, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Complete Blockage; Off-Label Use; Separation Problem

  The patient was treated for an abdominal aortic aneurysm on (b)(6)2017. Coil embolization of the inferior mesenteric artery was performed. The AFX Bifurcated Stent Graft (BSG) and AFX Cuff were deployed via left access with a two-stent overlap. Final angiography confirmed no Endoleak, and the procedure was completed without issues. On (b)(6)2026, it was identified that the junction between the AFX BSG and the AFX Cuff had become partially separated. Although the patient was being managed under observation, a reintervention was planned because an enlargement of the aneurysm diameter was observed. Additionally, the AFX BSG left limb/common iliac artery is occluded and thrombectomy is scheduled to be performed concurrently. Reintervention is scheduled for (b)(6)2026.Reintervention was performed on (b)(6)2026 with the implant of an AFX Vela Infrarenal aligned with the proximal end. Although no Endoleak to the sac was confirmed, balloon touch-up was performed and the AFX Vela Infrarenal migrated proximally; therefore, a Gore (non-Endologix) Excluder Cuff was then deployed at the distal end of the AFX Vela Infrarenal to complete the procedure. The final patent status was not reported.

  Patient problems: Aneurysm; Clinical Endoleak; Obstruction/Occlusion

  MAUDE report 50056611 ↗
• InjuryMay 5, 2023Improper 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 (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL ON (B)(6) 2016. IT SHOULD BE NOTED THAT PRIOR TO THE INDEX PROCEDURE, THE SIZING SHEET DATED (B)(6) 2016, THE NECK DIAMETER WAS OFF LABEL AS IT MEASURED 17.2MM AND SHOULD MEASURE BETWEEN 18 AND 32MM. ADDITIONALLY, THE MAX ANEURYSM DIAMETER WAS OFF LABEL AS IT MEASURED AT 49.9MM AND SHOULD MEASURE = 50MM. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, THE PATIENT WAS TRANSFERRED FROM AN OUTSIDE FACILITY ON 04/04/2023 DUE TO TYPE IA ENDOLEAK WITH A POTENTIAL CONTAINED RUPTURE. IT IS UNKNOWN WHEN THE TYPE IA ENDOLEAK WAS IDENTIFIED. ON (B)(6) 2023, REINTERVENTION WAS PERFORMED WITH THE IMPLANT OF A COOK ALPHA (NON-ENDOLOGIX) IN THE AORTA, A GORE VIABAHN VBX (NON-ENDOLOGIX) IN THE CELIAC ARTERY FENESTRATION, A GORE VIABAHN VBX (NON-ENDOLOGIX) IN THE SUPERIOR MESENTERIC ARTERY FENESTRATION, AND A GORE VBX (NON-ENDOLOGIX) IN THE RIGHT RENAL ARTERY LASER FENESTRATION. COMPLETION AORTOGRAM DEMONSTRATED SUCCESSFUL EXCLUSION OF THE TYPE IA ENDOLEAK AND A DELAYED TYPE II ENDOLEAK. THE PHYSICIAN ELECTED TO END THE PROCEDURE AND THE PATIENT WAS

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16878675 ↗
• InjuryJun 14, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT INITIALLY UNDERWENT AN AORTIC ARCH REPLACEMENT FOR AORTIC DISSECTION. APPROXIMATELY (2) TWO MONTHS AFTER POST INITIAL PROCEDURE PATIENT UNDERWENT AN EVAR PROCEDURE. THE PATIENT WAS IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT. AT AN UNKNOWN DATE, AN ENLARGEMENT OF THE AORTOILIAC ANEURYSM WAS CONFIRMED AND A TYPE 1B ENDOLEAK WAS SUSPECTED AS THE CAUSE. APPROXIMATELY (4) FOUR YEARS POST EVAR PROCEDURE A RE-INTERVENTION WAS PERFORMED. THE PHYSICIAN ELECTED TO IMPLANT AN AFX LIMB IN THE LEFT LEG TO RESOLVE THE ENDOLEAK.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 11995385 ↗
• InjuryDec 2, 2020Patient-Device Incompatibility; Separation Problem; Patient-Device Incompatibility; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A VELA SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE DURING A ROUTINE FOLLOW UP, A TYPE 3A ENDOLEAK WITH SEPARATION BETWEEN THE BIFURCATED STENT GRAFT AND PROXIMAL EXTENSION, AND SAC EXPANSION OF APPROXIMATELY 1CM WAS IDENTIFIED. A SUCCESSFUL REINTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT A SUPRARENAL STENT GRAFT EXTENSION AND AN INFRARENAL STENT GRAFT EXTENSION TO RESOLVED HIS EVENT. THE PATIENT REPORTEDLY IS DOING WELL POST PROCEDURE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 10936493 ↗
• InjuryJun 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A VELA INFRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A COMPUTED TOMOGRAPHY (CT) IDENTIFIED A TYPE 1A ENDOLEAK AND GRAFT MIGRATION. AN INTERVENTION IS BEING PLANNED WITHIN THE NEXT SIX (6) MONTHS. REPORTEDLY, THE PATIENT IS FINE.

  Patient problems: Failure of Implant

  MAUDE report 10114846 ↗
• InjuryJan 15, 2020Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY, 7 MONTHS POST IMPLANT DURING A ROUTINE FOLLOW UP, A TYPE IIIB ENDOLEAK WAS IDENTIFIED. PHYSICIAN ELECTED TO IMPLANT ANOTHER BIFURCATED STENT GRAFT TO TREAT THIS EVENT. THE PATIENT IS DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 9594244 ↗
• InjuryApr 23, 2018Partial Blockage; Occlusion Within Device; Patient-Device Incompatibility; Partial Blockage; Occlusion Within Device; Patient-Device Incompatibility

  DURING THE INITIAL IMPLANT, IT WAS REPORTED THAT THE PHYSICIAN IMPLANTED A GORE EXCLUDER LEG ON THE RIGHT EXTERNAL ILIAC ARTERY TO THE COMMON ILIAC ARTERY THEN THE AFX WAS IMPLANTED ABOVE THE EXCLUDER LEG, LASTLY AFX PROXIMAL EXTENSION WAS IMPLANTED. ABOUT 8 MONTHS POST IMPLANT, CT SHOWED THROMBOTIC OCCLUSION OF THE RIGHT EXTERNAL ILIAC ARTERY TO THE COMMON ILIAC ARTERY. THE PHYSICIAN ELECTED TO PERFORM A THROMBECTOMY AND PLACED A NEW GORE VIABAHN. IT WAS NOTED BY THE PHYSICIAN THAT THE THROMBOSIS WAS DUE TO PATIENT ANATOMY AND ACCESS VESSEL AND WAS NOT A DEVICE RELATED ISSUE. THERE HAS BEEN NO ADDITIONAL PATIENT SEQUALAE REPORTED AT THIS TIME. DURING THE CLINICAL EVOLUTION OF THIS CASE ON (B)(6) 2018, IT WAS DISCOVERED THAT THERE WAS ALSO OCCLUSION IN THE LEG OF THE BIFURCATION ALONG WITH THE PREVIOUSLY REPORTED LIMB EXTENSION. (REPORT# 2031527-2017-00669)

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 7451207 ↗
• InjuryApr 19, 2018Failure To Adhere Or Bond; Hole In Material; Leak/Splash; Failure To Adhere Or Bond; Hole In Material; Leak/Splash

  THE PATIENT WAS IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND VELA SUPRARENAL ON (B)(6) 2015. ON A LATER DATE, THE PHYSICIAN SUSPECTED A TYPE 3A ENDOLEAK, BUT THIS LEAK WAS NOT CONFIRMED. IN ADDITION, THERE WAS POSSIBLE BILLOWING AND A TYPE 2 ENDOLEAK. NO ADVERSE EVENTS WERE REPORTED FOR THIS PATIENT WHOM WAS ASYMPTOMATIC. NO DEVICES WERE EXPLANTED AS THE PHYSICIAN RELINED THE AFX SYSTEM WITH AN AFX2 BIFURCATED STENT GRAFT AND NEW VELA SUPRARENAL.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7445892 ↗
• InjuryDec 28, 2017Failure To Adhere Or Bond; Detachment Of Device Component; Failure To Adhere Or Bond; Detachment Of Device Component

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION. IT WAS REPORTED THE PATIENT HAD A COMPONENT SEPARATION, AN ENDOLEAK WAS NOT INITIALLY REPORTED. THE PHYSICIAN IS PLANNING ON USING NELLIX OR OVATION TO TREAT THE PATIENT. A SECONDARY PROCEDURE HAS NOT BEEN COMPLETED OR SCHEDULED. THE PATIENT IS REPORTED TO BE DOING GOOD. THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 7153079 ↗
• InjuryJun 23, 2017Leak/Splash; Material Integrity Problem; Leak/Splash; Material Integrity Problem

  A PATIENT PREVIOUSLY IMPLANTED WITH AFX DEVICES TO REPAIR AN ABDOMINAL AORTIC ANEURYSM RETURNED FOR A PHYSICIAN VISIT. THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION. THE PHYSICIAN IDENTIFIED ANEURYSM SAC GROWTH AND POTENTIAL TYPE 3 ENDOLEAK. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL WHERE AN ANGIOGRAM WAS COMPLETED. ANGIOGRAM SHOWED A TYPE 2 ENDOLEAK OR POSSIBLE ENDOTENSION. THE PHYSICIAN IDENTIFIED 2 LUMBAR ARTERIES THAT MAY BE COMMUNICATING WITH THE ANEURYSM SAC AND PLANS TO LIGATE THE ARTERIES. TO DATE, THE CASE STATUS AND PATIENT CONDITION HAVE NOT BEEN REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 6665606 ↗
• InjuryMay 30, 2017Failure To Adhere Or Bond; Leak/Splash; Off-Label Use; Improper or Incorrect Procedure or Method; Failure To Adhere Or Bond; Leak/Splash; Off-Label Use; Improper or Incorrect Procedure or Method

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION. THE AFX DEVICES WERE IMPLANTED TO TREAT A DISSECTING AORTIC ANEURYSM. DURING THE INITIAL IMPLANT OF THE DEVICES, THE PHYSICIAN OBSERVED A TYPE 3A ENDOLEAK AND IMPLANTED A NON-ENDOLOGIX GORE STENT TO INCREASE THE OVERLAP BETWEEN THE MAIN BODY STENT AND THE PROXIMAL EXTENSION. AT THE COMPLETION OF THE INITIAL PROCEDURE THE PATIENT STILL HAD A RESIDUAL TYPE 3A ENDOLEAK REMAINING. THE PHYSICIAN OPTED TO CONCLUDE THE PROCEDURE AND MONITOR THE PATIENT. ON (B)(6) 2017 THE PATIENT HAD LIMITED BLOOD FLOW TO THE LEGS AND THE PHYSICIAN ELECTED TO COMPLETE SURGERY TO CORRECT A RETROGRADE DISSECTION LOCATED AT THE RIGHT DISTAL EDGE OF THE MAIN BODY IMPLANT. THE PHYSICIAN PLACED A COIL IN THE RIGHT INTERNAL ILIAC ARTERY ALONG WITH A NON-ENDOLOGIX GORE STENT TO PREVENT LIMITED BLOOD FLOW FROM REOCCURRING. DURING THE SECONDARY INTERVENTION THE REPORTED RESIDUAL TYPE 3A ENDOLEAK WAS NOT OBSERVED AND APPEARED TO HAVE RESOLVED ITSELF. THE SECONDARY PROCEDURE WAS COMPLETED AND THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

  Patient problems: Failure of Implant; Intimal Dissection; Ischemia; Stenosis; Vascular Dissection

  MAUDE report 6599598 ↗
• InjuryDec 7, 2016Failure To Adhere Or Bond; Hole In Material; Leak/Splash; Failure To Adhere Or Bond; Hole In Material; Leak/Splash

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION ON (B)(6) 2016. FOLLOWING THE INITIAL IMPLANT PROCEDURE AN ANGIOGRAM IDENTIFIED A POSSIBLE TYPE 2 ENDOLEAK OR A POSSIBLE TYPE 3A ENDOLEAK BETWEEN THE MAIN BODY STENT AND THE PROXIMAL EXTENSION. FURTHER REVIEW OF THE ANGIOGRAM ALSO SHOWED A POSSIBLE TYPE 3B ENDOLEAK AT THE SUTURE LINE OF THE MAIN BODY AS WELL AS A TYPE 1B ENDOLEAK FROM THE LEFT LIMB OF THE MAIN BODY. THE TYPE 3B ENDOLEAK OF THE MAIN BODY WAS THOUGHT TO BE DUE TO DAMAGE CAUSED BY THE PROXIMAL EXTENSION DURING IMPLANT. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL LIMB EXTENSION TO RESOLVE THE TYPE 1B ENDOLEAK AS WELL AS AN INFRARENAL AORTIC EXTENSION TO SEAL THE TYPE 3A ENDOLEAK. A FINAL SCAN SHOWED THE PATIENT STILL HAD AN UNKNOWN ENDOLEAK REMAINING AT THE MAIN BODY, POSSIBLE TYPE 2 OR TYPE 3 ENDOLEAK. THE PHYSICIAN IS PLANNING TO RELINE THE WITH AN ADDITIONAL BIFURCATED STENT. A SECONDARY INTERVENTION HAS NOT BEEN COMPLETED OR SCHEDULED.

  Patient problems: Failure of Implant

  MAUDE report 6153716 ↗
• InjuryDec 6, 2016Occlusion Within Device; Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Occlusion Within Device; Improper or Incorrect Procedure or Method; Device-Device Incompatibility

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT AND AN INFRARENAL AORTIC EXTENSION ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT WAS FOUND TO HAVE AN OCCLUSION FROM THROMBUS IN THE MAIN BODY OF THE BIFURCATED STENT TO THE LIMB. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICES AND COMPLETE AN OPEN REPAIR. THE PATIENT IS IN STABLE CONDITION FOLLOWING THE SECONDARY INTERVENTION.

  Patient problems: Occlusion; Thrombosis

  MAUDE report 6148967 ↗

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-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-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-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-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-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• 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-0592-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• 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-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

…and 1 more.