AFX Endovascular AAA System BA25-120/I20-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00818009011985), received between May 13, 2016 and Nov 17, 2023 — classified as 1 death, 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2023Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS TREATED FOR ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2016 WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL. ON 01 NOVEMBER 2023, ROUTINE FOLLOW UP COMPUTED TOMOGRAPHY IDENTIFIED THAT THE AAA HAS ENLARGED WITH NO IDENTIFIABLE LEAK. HOWEVER, THE PHYSICIAN SUSPECTS A TYPE IIIB ENDOLEAK. THE PATIENT IS REPORTED TO BE GOOD. REINTERVENTION IS SCHEDULED FOR (B)(6) 2023.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 18163605 ↗
• InjurySep 14, 2022Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT. APPROXIMATELY SIXTEEN DAYS POST INITIAL PROCEDURE, REINTERVENTION WAS COMPLETED FOR AN UNKNOWN REASON WITH THE IMPLANT OF AN AFX VELA SUPRARENAL (REPORTED UNDER MFR# 2031527-2022-00225). NOW, APPROXIMATELY SIX AND A HALF (6.5) YEARS LATER, ROUTINE FOLLOW-UP IDENTIFIED A POSSIBLE TYPE 3B ENDOLEAK WITH ANEURYSM ENLARGEMENT. REPORTEDLY, THE COMPUTERIZED TOMOGRAPHY DID NOT SHOW EVIDENCE OF GRAFT LEAKAGE AND WAS CLASSIFIED AS ENDOTENSION. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT. THE FINAL PATIENT STATUS WAS REPORTED TO BE GOOD.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 15419394 ↗
• InjurySep 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT. SIXTEEN (16) DAYS POST INITIAL PROCEDURE, RE-INTERVENTION WAS COMPLETED DUE TO AN UNKNOWN CAUSE WITH THE IMPLANT OF AN AFX VELA SUPRARENAL. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE REGARDING THIS INITIAL REPORT.

  Patient problems: Insufficient Information

  MAUDE report 15415158 ↗
• InjuryAug 8, 2022Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL AND AN AFX VELA INFRARENAL, AND ONE (1) AFX LIMB STENT GRAFT. IT WAS NOTED THAT DURING THE INDEX PROCEDURE, A FLARED ILIAC LIMB WAS PLACED WITH THE INTENT OF COILING AT SOME POINT IN THE FUTURE. APPROXIMATELY TWO (2) YEARS POST-INITIAL PROCEDURE REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF THREE (3) AFX LIMB STENT GRAFTS TO TREAT ANEURYSM ENLARGEMENT. ADDITIONALLY, THE CLINICAL EVALUATION SHOWED REASONABLE EVIDENCE TO SUGGEST A TYPE IB ENDOLEAK OF THE RIGHT COMMON ILIAC ARTERY (RCIA) WITH AN INFRARENAL STENT PLACED IN THE RCIA (OFF-LABEL). (REPORTED UNDER MFR#2031527-2018-00295). NOW, APPROXIMATELY FOUR (4) YEARS POST-REINTERVENTION, AT TYPE IIIA ENDOLEAK WITH LIMB SEPARATION WAS IDENTIFIED AT ROUTINE FOLLOW-UP. REINTERVENTION HAS BEEN SCHEDULED. THE PATIENT IS REPORTED TO BE DOING OKAY.

  Patient problems: Failure of Implant

  MAUDE report 15184328 ↗
• InjuryMar 8, 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. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, ANEURYSM ENLARGEMENT WITH A TYPE IB ENDOLEAK AND AN ENDOLEAK AT AN INDETERMINATE ORIGIN WERE IDENTIFIED. REINTERVENTION WAS COMPLETED WITH UNKNOWN NON-ENDOLOGIX DEVICES. THE PATIENT STATUS POST-REINTERVENTION WAS NOT REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 13687732 ↗
• InjuryApr 26, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IB ENDOLEAK AND ANEURYSM ENLARGEMENT (UNKNOWN DIAMETER). THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN ADDITIONAL AFX LIMB STENT GRAFT ON (B)(6) 2017. REFERENCE MFR. REPORT # 2031527-208-0021 FOR THE REPORTED EVENT. NOW ANOTHER THREE AND A HALF (3.5) YEARS LATER, THE PATIENT PRESENTED WITH A TORN GRAFT (CLASSIFIED AS A TYPE IIIB ENDOLEAK) OF THE BIFURCATED STENT GRAFT. THE PHYSICIAN TREATED BY IMPLANTING A GORE (NON-ENDOLOGIX) EXCLUDER DEVICE ON (B)(6) 2021. THE PATIENT IS REPORTEDLY IN GOOD CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 11729497 ↗
• InjurySep 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT, AN AFX INFRARENAL AORTIC EXTENSION, VELA SUPRARENAL AND VELA INFRARENAL DEVICES AND AN ILIAC LIMB STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THERE WAS A TYPE 2 ENDOLEAK (ANATOMY-RELATED) REPORTED POST INITIAL PROCEDURE. DUE TO SAC GROWTH TWO YEARS POST IMPLANT THE SAC, LUMBAR ARTERIES AND IMA WERE COILED. IT SEEMED TO HAVE SOME BENEFIT BUT THE ENDOLEAK CONTINUED. APPROXIMATELY 4.5 YEARS POST INITIAL PROCEDURE A COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) SHOWS A TYPE 3A ENDOLEAK BETWEEN THE MAIN BODY AND FIRST PROXIMAL EXTENSION. THE PHYSICIAN ELECTED TO RELINE THE BIFURCATED STENT GRAFT, VELA SUPRARENAL AND LIMB STENT GRAFT. THE ENDOLEAK WAS CONFIRMED RESOLVED, AND THE PATIENT IS STABLE AND AT HOME.

  Patient problems: Failure of Implant

  MAUDE report 10587471 ↗
• DeathMay 24, 2019Material Puncture/Hole; Material Integrity Problem; Material Puncture/Hole; Material Integrity Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION AND AN INFRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENT TO THE EMERGENCY ROOM WITH A RUPTURED ANEURYSM. A TYPE 3A AND POSSIBLE 3B ENDOLEAKS WERE IDENTIFIED BY COMPUTERIZED TOMOGRAPHY (CT) SCAN. THE PATIENT WAS REPORTED TO BE UNSTABLE HOWEVER A SECONDARY PROCEDURE WAS ATTEMPTED TO RELINE THE ORIGINAL IMPLANTED WITH ANOTHER INFRARENAL STENT GRAFT EXTENSION. DURING THE SECONDARY PROCEDURE, THE PATIENT CODED MULTIPLE TIME AND CPR WAS ADMINISTERED BUT ULTIMATELY THE PATIENT EXPIRED. ADDITIONAL INFORMATION: DURING THE CLINICAL ASSESSMENT, THE REPORTED POSSIBLE 3B ENDOLEAK WAS CONFIRMED.

  Patient problems: Death; Failure of Implant; Rupture

  MAUDE report 8640768 ↗
• InjuryMar 26, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED PER CLINICAL ASSESSMENT CONFIRMING THAT MULTIPLE TYPE II ENDOLEAKS WERE PRESENT AT THE TIME OF THE REPORTED EVENT. IN ADDITION, PATIENT HAD A CHRONIC THROMBOTIC CONDITION PRIOR TO THE INITIAL IMPLANT. BASED ON THIS ADDITIONAL INFORMATION, THERE IS NO ALLEGED DEFICIENCY RELATED TO AN ENDOLOGIX DEVICE, AND THIS IS NO LONGER A REPORTABLE EVENT.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8453492 ↗
• InjuryApr 11, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  AN AFX BIFURCATED, VELA SUPRARENAL AND INFRARENAL EXTENSION, AND ONE (1) ILIAC LIMB WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS NOTED THAT DURING THE INDEX PROCEDURE, A FLARED ILIAC LIMB WAS PLACED WITH THE INTENT OF COILING AT SOME POINT IN THE FUTURE. THE PHYSICIAN DECIDED ITS TIME AS THE RIGHT ILIAC ANEURYSM IS GROWING. A SECONDARY PROCEDURE WAS COMPLETED ON (B)(6) 2018, THE PHYSICIAN ELECTED TO IMPLANT THREE OVATION ILIAC LIMBS. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED

  Patient problems: Aneurysm

  MAUDE report 7421540 ↗
• InjuryJan 12, 2017Failure To Adhere Or Bond; Hole In Material; Leak/Splash; Failure To Adhere Or Bond; Hole In Material; Leak/Splash

  ADDITIONAL INFORMATION WAS OBTAINED SINCE THE INITIAL REPORTING. ON (B)(6) 2017, A SECONDARY PROCEDURE WAS CONDUCTED TO RELINE WITH AN OVATION DEVICE

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 6248186 ↗
• InjuryOct 27, 2016Kinked; Kinked

  IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2015 WITH A BIFURCATED STENT AND TWO SUPRARENAL AORTIC EXTENSIONS. A FOLLOW UP COMPUTED TOMOGRAPHY (CT), SHOWED A KINK IN THE BIFURCATED STENT WITH NO ENDOLEAK PRESENT. ON (B)(6) 2016 THE PHYSICIAN ELECTED TO IMPLANT TWO ADDITIONAL SUPRARENAL AORTIC EXTENSIONS TO COVER THE KINKED AREA AND INCREASE OVERLAP INTO THE NECK.

  Patient problems: Failure of Implant

  MAUDE report 6062420 ↗
• InjuryAug 17, 2016Failure To Adhere Or Bond; Hole In Material; Leak/Splash; Failure To Adhere Or Bond; Hole In Material; Leak/Splash

  PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED DEVICE, A SUPRARENAL AORTIC EXTENSION, AND A LIMB STENT ON (B)(6) 2015. ON (B)(6) 2016 THE PATIENT WAS FOUND TO HAVE A POTENTIAL TYPE 1B ENDOLEAK. ON (B)(6) 2016 THE PATIENT HAD A SUBSEQUENT ENDOVASCULAR PROCEDURE AND THE PHYSICIAN ELECTED TO ADD A LIMB EXTENSION TO THE RIGHT SIDE, THE PHYSICIAN ALSO BALLOONED THE EXTENSION AFTER IMPLANT. AN ANGIOGRAM DURING THE PROCEDURE WAS STILL SHOWING AN ENDOLEAK. THE PHYSICIAN DISCOVERED THE LEAK WAS NOT A TYPE 1B BUT A TYPE 3B. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANT AND ADDED AN ADDITIONAL BIFURCATED STENT, AND AN ADDITIONAL SUPRARENAL AORTIC EXTENSION. THE PATIENT IS STABLE.

  Patient problems: Failure of Implant

  MAUDE report 5884919 ↗
• InjuryMay 13, 2016Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2016 WITH A BIFURCATED, AN INFRARENAL AORTIC EXTENSION, AND A LIMB STENT GRAFT. SUBSEQUENTLY, DURING A ROUTINE FOLLOW UP, COMPUTED TOMOGRAPHY REVEALED THE PATIENT HAD A TYPE 1A ENDOLEAK. PHYSICIAN IMPLANTED AN INFRARENAL AORTIC EXTENSION TO RESOLVE THE LEAK. PROCEDURE WAS SUCCESSFUL AND PATIENT IS DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 5654998 ↗

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-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-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-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-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-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-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-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

…and 1 more.