AFX Endovascular AAA System I20-20/C55F SARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00818009011435), received between Jul 14, 2017 and Mar 25, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Off-Label Use” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2024Off-Label Use; Material Puncture/Hole; Patient-Device Incompatibility; Device-Device Incompatibility; Off-Label Use; Material Puncture/Hole; Patient-Device Incompatibility; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A SUPRARENAL AORTIC EXTENSION, TWO (2) ILIAC LIMBS AND AN OVATION EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. APPROXIMATELY SIX AND A HALF (6.5) YEARS POST INITIAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE A TYPE 3B ENDOLEAK FROM ONE OF THE ILIAC LIMBS. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED. ADDITIONAL INFORMATION: THE CLINICAL EVALUATION SHOWS THAT THE ANGIOGRAM DATED 03/08/2024 SHOWS A THE ORIGINAL GRAFTS WERE RELINED WITH A NON-ENDOLOGIX MAIN BODY AND LIMBS AND THE ENDOLEAK WAS RESOLVED.

  Patient problems: Clinical Endoleak

  MAUDE report 18968783 ↗
• InjuryMar 21, 2022Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND AN AFX LIMB STENT GRAFT. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE A STUDY REVIEW IDENTIFIED A TYPE IIIA ENDOLEAK AND A HYPOGASTRIC ANEURYSM. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF AN AFX VELA INFRARENAL SEALING THE TYPE IIIA ENDOLEAK. AN OVATION IX ILIAC LIMB WAS IMPLANTED TO TREAT THE HYPOGASTRIC ANEURYSM. THE FINAL PATIENT STATUS WAS STABLE POST-PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 13840046 ↗
• InjuryMar 6, 2019Off-Label Use; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Off-Label Use; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND FOUR (4) LIMB STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 2.5 YEARS POST INITIAL PROCEDURE, A TYPE 1B ENDOLEAK WAS REPORTED. A SECONDARY PROCEDURE WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT (2) ADDITIONAL LIMB STENT GRAFT EXTENSIONS. THE SECONDARY PROCEDURE WAS SUCCESSFUL IN RESOLVING THE REPORTED TYPE 1B ENDOLEAK. THE PATIENT WENT HOME THE NEXT DAY.

  Patient problems: Failure of Implant

  MAUDE report 8395844 ↗
• InjuryDec 14, 2018Leak/Splash; Insufficient Device Problem Information; Leak/Splash; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION AND TWO (2) LIMB STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). AN ADDITIONAL INFRARENAL STENT GRAFT EXTENSION WAS IMPLANTED ON (B)(6) 2018 TO RESOLVE A PREVIOUS REPORTED EVENT. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, A TYPE 1B ENDOLEAK WAS REPORTED. THE PHYSICIAN ELECTED TO IMPLANT A OVATION LIMB TO RESOLVE THIS EVENT. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. NOTE: THIS PATIENT HAD A PREVIOUS REPORT EVENT THAT WAS RESOLVED AND REPORTED UNDER 2031527-2018-00062 IN (B)(6) 2018.

  Patient problems: Failure of Implant

  MAUDE report 8166975 ↗
• InjurySep 14, 2018Off-Label Use; Off-Label Use

  THE PATIENT WAS INITIALLY TREATED WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT ON (B)(6) 2016 FOR AN ILIAC OCCLUSIVE CASE. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, A 90% STENOSIS IN THE LEFT COMMON ILIAC WAS DETECTED BY ANGIOGRAM WITH NO KINK IN THE GRAFT. ENDOLOGIX BECAME AWARE OF THE REPORTED ADVERSE EVENT AND PRODUCT PROBLEM ON (B)(6) 2018. THE PHYSICIAN PLANS TO TREAT THE PATIENT BY EXPANDING THE OCCLUDED LIMB WITH A 10X4 BALLOON.

  Patient problems: Stenosis

  MAUDE report 7877531 ↗
• InjuryMay 22, 2018Occlusion Within Device; Occlusion Within Device

  AT THE COMPLETION OF THE CLINICAL ASSESSMENT ON 04/23/2018 FOR A PERVIOUS REPORT EVENT, CLINICAL WAS ABLE TO FIND SUBSTANTIAL EVIDENCE TO SUPPORT THE FOLLOWING ADDITIONAL FINDINGS OF SNORKELED AND OCCLUDED RIGHT INTERNAL ILIAC ARTERY WHERE A NON- ENDOLOGIX SNORKEL STENT WAS IMPLANTED. PREVIOUS REPORTED EVENT DETAIL- (2031527-2018-00139) ON (B)(6) 2015, THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT, TWO (2) SUPRARENAL EXTENSION AND THREE (3) LIMB EXTENSIONS. ON 02/02/2018, ENDOLOGIX WAS MADE AWARE OF A TYPE 3A ENDOLEAK WITH LIMB SEPARATION. ON (B)(6) 2018, THE PHYSICIAN ELECTED TO IMPLANT THREE (3) 22X45 OVATION EXTENSION TO SUCCESSFULLY BRIDGE THE SEPARATION. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 7535727 ↗
• InjuryJul 14, 2017Failure To Adhere Or Bond; Leak/Splash; Improper or Incorrect Procedure or Method; Failure To Adhere Or Bond; Leak/Splash; Improper or Incorrect Procedure or Method

  AN AFX2 BIFURCATED STENT GRAFT, SUPRARENAL CUFF, AND ONE LIMB EXTENSION WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2017, APPROXIMATELY 1 YEAR POST-OP, THE PATIENT RETURNED FOR A FOLLOW-UP CT WHICH IDENTIFIED A TYPE 1B ENDOLEAK FROM THE RIGHT COMMON ILIAC. THE PATIENT IS SCHEDULED TO RETURN AT AN UNKNOWN DATE FOR AN INVESTIGATIVE ANGIOGRAM AND POSSIBLE RE-INTERVENTION. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 6716319 ↗

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-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-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-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-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-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

…and 1 more.