AFX Endovascular AAA System BA25-80/I20-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00818009012210), received between Apr 29, 2016 and Oct 13, 2023 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 13, 2023Lack of Effect; 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 PROXIMAL EXTENSION. APPROXIMATELY SEVEN AND A HALF (7.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A POSSIBLE TYPE IB ENDOLEAK AND ANEURYSM ENLARGEMENT OF THE RIGHT COMMON ILIAC (MEASURING MORE THAN 25MM). THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING WITH AN AFX2 BIFURCATED STENT GRAFT, ONE (1) ADDITIONAL AFX VELA SUPRARENAL AND ONE (1) AFX LIMB STENT GRAFT ON (B)(6) 2023. REPORTEDLY, THE ENDOLEAK WAS SUCCESSFULLY RESOLVED AND THE ANEURYSM EXCLUDED. THE PATIENT IS REPORTEDLY DOING WELL POST RE-INTERVENTION. AFTER THE INITIAL REPORT THE CLINICAL EVALUATION ALSO SHOWS REASONABLE EVIDENCE TO SUGGEST A TYPE II ENDOLEAK (LUMBAR) OCCURRED (NON-DEVICE RELATED) THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THESE ADDITIONAL FINDINGS WERE DISCOVERED DURING REVIEW OF THE 92-MONTH COMPUTED TOMOGRAPHY SCAN ((B)(6) 2023). ALSO, THERE WAS AN ADDITIONAL ENDOVASCULAR PROCEDURE DUE TO POST OPERATIVE RIGHT LIMB OCCLUSION THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THESE ADDITIONAL FINDINGS WERE DISCOVERED DURING REVIEW OF THE

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17929906 ↗
• InjurySep 28, 2022Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND AN AFX LIMB STENT GRAFT. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, TWO (2) TYPE IIIA ENDOLEAKS (AORTIC AND RIGHT ILIAC) WITH IMPLANT SEPARATION ON THE RIGHT ILIAC WERE IDENTIFIED. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF TWO (2) AFX VELA INFRARENAL AND ONE AFX VELA SUPRARENAL. NO ENDOLEAKS WERE IDENTIFIED POST-REPAIR. THE PATIENT WAS REPORTED TO BE DOING WELL AND WAS DISCHARGED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 15499289 ↗
• InjuryAug 5, 2021Use of Device Problem; Separation Problem; Use of Device Problem; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, AN SUPRARENAL STENT GRAFT AND THREE (3) LIMB STENT GRAFTS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 5.5 YEARS POST INITIAL PROCEDURE, A TYPE 3A ENDOLEAK WITH COMPONENT SEPARATION WAS IDENTIFIED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH A LIMB STENT GRAFT, AN ILIAC LIMB EXTENSION AND A PALMAZ STENT. REPORTEDLY, INTERVENTION WAS SUCCESSFUL AND THE PATIENT IS DOING WELL.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12283214 ↗
• InjuryNov 23, 2018Leak/Splash; Appropriate Device Problem Term/Code Not Available; Leak/Splash; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS PREVIOUSLY IMPLANTED WITH A TWO (2) BIFURCATED STENT GRAFTS, A SUPRARENAL STENT GRAFT EXTENSION AND A LIMB STENT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST IMPLANT, A ROUTINE FOLLOW-UP CT REVEALED AN ENLARGING AAA WITH NO IDENTIFIABLE LEAK. THE PATIENT WAS RELINED WITH A NON ENDOLOGIX DEVICE (GORE EXCLUDER) ON (B)(6) 2018. THE PATIENT WAS REPORTED IN GOOD CONDITION POST-SECONDARY PROCEDURE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8100046 ↗
• InjuryApr 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT, FOUR (4) LIMB STENT GRAFTS, AND AN INFRARENAL AORTIC EXTENSION ON (B)(6) 2016. SECONDARY PROCEDURE WAS COMPLETED ON (B)(6) 2016 FOR AN UNKNOWN REASON AND THE PATIENT WAS IMPLANTED WITH A NEW AFX LIMB STENT GRAFT.

  Patient problems: No Information

  MAUDE report 7445931 ↗
• MalfunctionDec 14, 2017Collapse; Improper or Incorrect Procedure or Method; Malposition of Device; Collapse; Improper or Incorrect Procedure or Method; Malposition of Device

  DURING THE INITIAL PROCEDURE, WHILE DEPLOYING THE MAIN BODY IT WAS DISCOVERED THROUGH ANGIO THAT THE MAIN BODY WAS PLACED ABOVE THE RENALS AND THE ILIAC LIMBS WERE MUCH HIGHER COMPARED TO THE ORIGINAL POSITION. THE PHYSICIAN ATTEMPTED TO SNARE THE LIMBS TO PLACE IT BACK IN THE ILIAC BUT THE LIMBS COLLAPSE. A MEDTRONIC AORTOMONOILIAC WAS PLACED AND THE PHYSICIAN PERFORMED A FEMORO-FEMORA BYPASS TO SUCCESSFULLY RESOLVE THE ISSUE. PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7119766 ↗
• InjuryOct 20, 2017Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT, A SUPRARENAL AORTIC EXTENSION, AN INFRARENAL AORTIC EXTENSION AND A LIMB EXTENSION. DURING THE INITIAL IMPLANT PROCEDURE THE PHYSICIAN LOST WIRE ACCESS AND WAS UNABLE TO PLACE A LIMB ON THE LEFT SIDE AS PLANNED. ON (B)(6) 2017 THE PATIENT CAME IN FOR A FOLLOW UP AND COMPUTED TOMOGRAPHY (CT) SHOWED THE PATIENT HAD A TYPE 1B ENDOLEAK. THE PATIENT HAS NOT HAD A SECONDARY PROCEDURE AND IS REPORTED TO BE WELL. THE PHYSICIAN IS PLANNING ON COMPLETING A SECONDARY INTERVENTION. TO DATE A SECONDARY INTERVENTION HAS NOT BE SCHEDULED. THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 6965797 ↗
• InjuryApr 29, 2016Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT AND AN INFRARENAL AORTIC EXTENSION ON (B)(6) 2016. UPON FOLLOW UP, COMPUTED TOMOGRAPHY (CT) SHOWED A PARTIAL STENT COLLAPSE AND A TYPE 1A ENDOLEAK. THE PHYSICIAN ELECTED TO USE A STIFF WIRE TO ALTER THE INITIAL INFRARENAL DEVICE AND IMPLANTED A SUPRARENAL AORTIC EXTENSION TO SEAL THE ENDOLEAK. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 5622675 ↗

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-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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-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-0596-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL
• 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-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-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• 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-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL

…and 1 more.