AFX Endovascular AAA System I20-13/C70F SARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00818009011442), received between Jun 29, 2017 and Mar 11, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Complete Blockage” (1 report).

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.

• InjuryMar 11, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL EXTENSION, AND AN AFX ILIAC EXTENSION FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2021. APPROXIMATELY THREE AND A HALF (3.5) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A TYPE IB ENDOLEAK IN THE RIGHT ILIAC LIMB WAS IDENTIFIED. THE PHYSICIAN ELECTED TO IMPLANT AN AFX ILIAC LIMB ON (B)(6) 2025. THE FINAL COMPUTED TOMOGRAPHY (CT) REVEALED THAT THE DISTAL TYPE IB ENDOLEAK WAS SUCCESSFULLY RESOLVED. THE PATIENT WAS REPORTED AS DOING FINE POST SECONDARY PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 21576358 ↗
• InjuryOct 4, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL. REPORTEDLY, THE PHYSICIAN HAD DIFFICULTY ADVANCING A BALLOON CATHETER THROUGH THE LEFT EXTERNAL ILIAC ARTERY DUE TO THE TORTUOSITY OF THE VESSEL, BALLOON TOUCH-UP WAS PERFORMED ONLY FROM THE RIGHT SIDE. THE BALLOON TOUCH-UP CAUSED THE STENT OF THE LEFT LIMB OF THE AFX2 BIFURCATED STENT GRAFT TO BECOME PRESSED. ANGIOGRAPHY SHOWED A TYPE IB ENDOLEAK FROM THE RIGHT LEG. THE PHYSICIAN ATTEMPTED TO DEPLOY AN AFX LIMB AT THE RIGHT COMMON AND EXTERNAL ILIAC ARTERIES; HOWEVER, THIS CAUSED THE AFX2 BIFURCATED STENT TO BECOME PRESSED AGAIN. SUBSEQUENTLY, A TYPE IB ENDOLEAK FROM THE LEFT COMMON ILIAC ARTERY WAS CONFIRMED. THIS DID NOT RESOLVE WITH BALLOON TOUCH-UP, THE PHYSICIAN ELECTED TO DEPLOY THE AFX LIMB IN THE LEFT EXTERNAL ILIAC ARTERY. BALLOON TOUCH-UP WAS PERFORMED; HOWEVER, THE AFX LIMB WAS UNABLE TO BE FULLY EXPANDED AND THERE WAS STILL RESIDUAL OF THE TYPE IB ENDOLEAK REMAINED. THE PHYSICIAN ELECTED TO END THE PROCEDURE AND MONITOR THE PATIENT. (REPORTED UNDER MFR#2031527-2021-00424). APPROXIMATELY SIX (6) MONTHS POST INITIAL PROCEDURE

  Patient problems: Failure of Implant; Pain

  MAUDE report 12573301 ↗
• InjuryJan 22, 2021Complete Blockage; Device-Device Incompatibility; Complete Blockage; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION, AND A LIMB STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE THE LEFT LIMB OF THE ENDOGRAFT WAS OCCLUDED. RE-INTERVENTION WAS COMPLETED. THE PHYSICIAN PERFORMED A FEMORAL-FEMORAL BYPASS. NO FURTHER INFORMATION PROVIDED. NOTE: THIS PATIENT IS PART OF A CLINICAL STUDY.

  Patient problems: Occlusion

  MAUDE report 11216484 ↗
• InjuryJul 14, 2020Migration; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A LIMB STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 1.5 YEARS POST INITIAL PROCEDURE, A TYPE 3A ENDOLEAK DUE TO MIGRATION OF THE LIMB STENT GRAFT WAS IDENTIFIED BY A COMPUTED TOMOGRAPHY (CT). AN INTERVENTION WAS COMPLETED ON (B)(6) 2020. THE PHYSICIAN ELECTED USE A NON- ENDOLOGIX (COOK CONVERTER) DEVICE TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 10273237 ↗
• InjuryNov 20, 2018Loss of or Failure to Bond; Leak/Splash; Loss of or Failure to Bond; Leak/Splash

  THE PATIENT WAS INITIALLY TREATED WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, A TYPE 1B ENDOLEAK WAS DETECTED CT SCAN. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8091661 ↗
• InjuryOct 25, 2018Difficult or Delayed Positioning; Obstruction of Flow; Material Deformation; Difficult or Delayed Positioning; Obstruction of Flow; Material Deformation

  THE PATIENT WAS INITIALLY TREATED WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT ON (B)(6) 2018. DURING THE INITIAL PROCEDURE, THE CONTRALATERAL LIMB DID NOT FULLY DEPLOY AND APPEARED CONSTRAINED AT THE BIFURCATION OF THE GRAFT. AFTER BALLOONING (PTA), THE STENT RECOILED BUT THE FLOW THROUGH THE GRAFT APPEARED ROBUST. THE PATIENT PRESENTED EMERGENTLY ONE (1) MONTH POST-OP WITH A COLD LEG AND A THROMBOSED RIGHT ILIAC LIMB OF THE AFX GRAFT. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY LYSIS AND IMPLANTING BILATERAL "KISSING" STENTS ON (B)(6) 2018, WHICH SUCCESSFULLY RESTORED FLOW. THE PATIENT IS DOING WELL AND THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Occlusion; Thrombosis

  MAUDE report 8005530 ↗
• InjuryApr 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(4) 2018, ENDOLOGIX WAS MADE AWARE OF A SECONDARY PROCEDURE PERFORMED ON (B)(6) 2018 TO TREAT A LESION FROM PATIENT STENOSIS THAT WAS NOTED ON THE DISTAL RIGHT ILIAC LIMB. PATIENT WAS REPORTED DOING WELL POST OPERATIVE SURGERY.

  Patient problems: Stenosis

  MAUDE report 7429529 ↗
• InjuryJun 29, 2017Partial Blockage; Kinked; Patient-Device Incompatibility; Partial Blockage; Kinked; Patient-Device Incompatibility

  ENDOLOGIX WAS MADE AWARE OF A CASE WHERE THE PATIENT HAD A LIMB THROMBOSIS. THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED DEVICE, TWO VELA INFRARENAL, AND ONE LIMB EXTENSION. THE PHYSICIAN ELECTED TO PLACING A MEDTRONIC ILIAC STENT TO FIX THE ISSUE. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Failure of Implant; Ischemia; Occlusion; Pain; Thrombosis

  MAUDE report 6679496 ↗

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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-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-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-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• 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-0596-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL
• 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-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
• 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-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.