AFX Endovascular AAA System BA28-80/I20-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00818009012265), received between Apr 23, 2016 and Aug 22, 2024 — classified as 2 deaths, 12 injuries.

The most frequently reported specific device problem is “Material Puncture/Hole” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2024Off-Label Use; Off-Label Use

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND OVATION IX EXTENDER IN THE RIGHT LIMB TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A TYPE IB, A SUSPECTED TYPE IA ENDOLEAK WAS OBSERVED AND THE ILIACS HAD ENLARGED. INTERVENTION OCCURRED ON (B)(6) 2024 WITH THE IMPLANTATION OF AN AFX LIMB STENT GRAFT, A VELA SUPRARENAL, AND AN OVATION IX EXTENDER. IT WAS REPORTED THAT THE ENDOLEAK WAS SEALED AND THE PATIENT IS STABLE. NOTE: THE SAFETY AND EFFECTIVENESS OF OTHER STENT OR STENT GRAFT DEVICES USED IN CONJUNCTION WITH THE AFX2 SYSTEM HAVE NOT BEEN ESTABLISHED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 20032819 ↗
• InjuryJul 23, 2024Material Puncture/Hole; Lack of Effect; Material Puncture/Hole; Lack of Effect

  THE PATIENT INITIALLY RECEIVED TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6)2015, WITH THE IMPLANTATION OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. ON (B)(6) 2024, IT WAS REPORTED THAT A POSSIBLE TYPE IB ENDOLEAK HAD BEEN IDENTIFIED. ON (B)(6) 2024, THE PATIENT UNDERWENT A RE-INTERVENTION. DURING THIS PROCEDURE, THE PHYSICIAN IMPLANTED THREE (3) OVATION IX ILIAC LIMBS, OVATION PRIME FILL POLYMER, AND AN ALTO MAIN BODY. THE FINAL PATIENT STATUS REMAINS UNKNOWN, AS THIS INFORMATION WAS NOT PROVIDED TO ENDOLOGIX.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19812414 ↗
• InjuryAug 3, 2022Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND TWO (2) LIMB STENT GRAFTS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 6 YEARS POST INITIAL PROCEDURE PATIENT PRESENTED WITH A TYPE 3B ENDOLEAK. THE PATIENT WAS TREATED WITH A GORE EXCLUDER (NON-ENDOLOGIX). REPORTEDLY, THE PATIENT WAS DISCHARGED WITHOUT ISSUE.

  Patient problems: Failure of Implant

  MAUDE report 15157377 ↗
• InjuryApr 7, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL PROXIMAL EXTENSION. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IB ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING A NON-ENDOLOGIX PROSTHETIC EXTENSION IN THE LEFT LEG SOMETIME IN YEAR 2020. AS THE EXACT DATE OF EVENT IS UNKNOWN, THE BEST ESTIMATE WAS USED, WHICH IS THE FIRST DAY AND MONTH TO YEAR 2020. APPROXIMATELY TWO (2) YEARS POST SECONDARY PROCEDURE, THE PATIENT PRESENTED WITH AN ENDOLEAK (AT INDETERMINATE ORIGIN). THE PHYSICIAN ELECTED TO CONVERT PATIENT TO OPEN REPAIR AND EXPLANT THE AFX DEVICES. THE FINAL PATIENT STATUS WAS NOT REPORTED. THE EXPLANTED DEVICES ARE AVAILABLE FOR RETURN/EVALUATION. THIS INDETERMINATE ORIGIN ENDOLEAK LEADING TO OPEN REPAIR AND EXPLANT OF THE AFX DEVICES WILL BE REPORTED UNDER A SEPARATE MEDICAL DEVICE REPORT (MDR).

  Patient problems: Failure of Implant

  MAUDE report 14044305 ↗
• InjuryApr 6, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL PROXIMAL EXTENSION. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IB ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING A NON-ENDOLOGIX PROSTHETIC EXTENSION IN THE LEFT LEG SOMETIME IN YEAR 2020. THIS TYPE IB ENDOLEAK WILL BE REPORTED UNDER A SEPARATE MEDICAL DEVICE REPORT (MDR). APPROXIMATELY TWO (2) YEARS POST SECONDARY PROCEDURE, THE PATIENT PRESENTED WITH AN ENDOLEAK (AT INDETERMINATE ORIGIN). THE PHYSICIAN ELECTED TO CONVERT PATIENT TO OPEN REPAIR AND EXPLANT THE AFX DEVICES. THE FINAL PATIENT STATUS WAS NOT REPORTED. THE EXPLANTED DEVICES ARE AVAILABLE FOR RETURN/EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 14026766 ↗
• InjuryDec 2, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX SUPRARENAL AORTIC EXTENSION. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY REVEALED A TYPE 3B ENDOLEAK. THE PHYSICIAN IMPLANTED A AFX BIFURCATED STENT GRAFT AND AN AFX LIMB STENT GRAFT ON THE RIGHT SIDE. THE FINAL ANGIOGRAM SHOWED THE LEAK HAD BEEN SEALED. (REPORTED UNDER MFR# 2031527-2016-00038). APPROXIMATELY NINE (9) YEARS POST-REINTERVENTION, A TYPE 3B ENDOLEAK AND A POSSIBLE TYPE IA ENDOLEAK WERE IDENTIFIED. REPORTEDLY, THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING WITH A GORE (NON-ENDOLOGIX) DEVICE. THE PATIENT STATUS WAS REPORTED AS DOING FINE POST RE-INTERVENTION. ADDITIONAL INFORMATION: THE CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST AN INABILITY TO ACCESS THE CONTRALATERAL LIMB NECESSITATING A CONVERSION TO AN AUI, SAC GROWTH OF 9MM AND LEFT LIMB STENT STENOSIS OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED.

  Patient problems: Aneurysm; Cardiac Arrest; Failure of Implant; Stenosis

  MAUDE report 12920069 ↗
• InjuryJul 12, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX BIFURCATED STENT GRAFT, A VELA SUPRARENAL PROXIMAL EXTENSION, AND A LIMB STENT GRAFT. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IIIA ENDOLEAK AND ANEURYSM ENLARGEMENT (UNKNOWN DIAMETER). THE PHYSICIAN PLANS TO RE-INTERVENE AND THE PATIENT IS REPORTEDLY IN STABLE CONDITION. ADDITIONAL INFORMATION: A RE-INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT AN ALTO MAIN BODY, OVATION PRIME FILL POLYMER, AND THREE (3) OVATION IX ILIAC LIMBS (ONE ON THE RIGHT SIDE AND TWO ON THE LEFT SIDE). THE FINAL PATIENT STATUS WAS REPORTED TO BE STABLE POST THE SECONDARY ENDOVASCULAR PROCEDURE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12150615 ↗
• InjuryMar 24, 2020Leak/Splash; Device-Device Incompatibility; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX BIFURCATED STENT GRAFT AND OVATION IX ILIAC LIMB. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE DUE TO THE USE OF AFX WITH A OVATION. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE 3A ENDOLEAK. REPORTEDLY, THE PATIENT IS NOT IN GOOD HEALTH AND THE PHYSICIAN HAS ELECTED NOT TREAT AT THIS TIME. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; No Information

  MAUDE report 9872456 ↗
• InjuryMar 2, 2020Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY FOUR AND A HALF (4.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IIIB ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN AFX2 BIFURCATED STENT GRAFT AND AN OVATION IX ILIAC LIMB DEVICE ON (B)(6) 2020; THIS PROCEDURE IS OFF-LABEL DUE TO NONCOMPATIBLE USE OF OVATION WITH AFX DEVICES. THE PATIENT IS REPORTEDLY DOING WELL AND THE ENDOLEAK WAS CONFIRMED RESOLVED. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9777654 ↗
• InjuryJun 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH BILATERAL TYPE IB ENDOLEAKS. HOWEVER, THE EXACT DATE OF EVENT IS UNKNOWN. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) AFX LIMB STENT GRAFTS AND AN ADDITIONAL BIFURCATED AFX2 DEVICE ON (B)(6) 2018. THE LEAK WAS CONFIRMED RESOLVED AT THE CONCLUSION OF THE PROCEDURE. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8708098 ↗
• InjuryApr 17, 2019Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED CONFIRMING THAT THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) ADDITIONAL SUPRARENAL AFX DEVICES ON (B)(6) 2019. NO LEAK WAS NOTED AT THE CONCLUSION OF THE SECONDARY INTERVENTION PER POSTOPERATIVE ANGIOGRAM. IN ADDITION, THE REPORTED TYPE IIIA ENDOLEAK WITH SAC GROWTH WERE REFUTED PER CLINICAL ASSESSMENT; RATHER, AN OFF-LABEL NECK DIAMETER (38MM) AT INITIAL IMPLANT AND LOSS OF OVERLAP WERE CONFIRMED.

  Patient problems: Aneurysm; Failure of Implant; No Code Available

  MAUDE report 8522577 ↗
• InjuryFeb 7, 2019Material Puncture/Hole; Material Puncture/Hole

  ADDITIONAL INFORMATION: THE REPORTED TYPE 3 ENDOLEAK WAS REPORTED TO BE A TYPE 3B ENDOLEAK THE PATIENT WAS REPORTED AS DOING WELL POST INTERVENTION AND THE INTERVENTION WAS REPORTED AS SUCCESSFUL IN RESOLVING THE TYPE 3B ENDOLEAK.

  Patient problems: Failure of Implant

  MAUDE report 8316686 ↗
• DeathJul 29, 2016Failure To Adhere Or Bond; Hole In Material; Leak/Splash; Failure To Adhere Or Bond; Hole In Material; Leak/Splash

  IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2016 WITH A BIFURCATED, A SUPRARENAL AORTIC EXTENSION, AND TWO LIMB EXTENSIONS. SUBSEQUENTLY, THE PHYSICIAN NOTED ON (B)(6) 2016 THAT THE PATIENT HAD EITHER A PERSISTENT TYPE 2 ENDOLEAK, OR AN ENDOLEAK TYPE 1A, IN THE LEFT COMMON ILIAC AND AORTA. PHYSICIAN ELECTED TO REPAIR VIA OPEN SURGERY ON (B)(6) 2016. SURGERY WENT WELL. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Death; Failure of Implant; Pain; Pseudoaneurysm; Renal Failure; Unspecified Infection

  MAUDE report 5835421 ↗
• DeathApr 23, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT AND AN INFRARENAL AORTIC EXTENSION ON (B)(6) 2016. DURING THE INITIAL PROCEDURE, THE ANESTHESIOLOGIST HAD COMPLICATIONS CAUSING THE LUNGS TO FILL WITH BLOOD. THE IMPLANT WAS COMPLETED WITH NO DEVICE RELATED COMPLICATIONS. FOUR HOURS POST PROCEDURE, THE PATIENT EXPIRED FROM COMPLICATIONS UNRELATED TO THE IMPLANTED STENTS.

  Patient problems: Blood Loss; Death

  MAUDE report 5602554 ↗

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