AFX Endovascular AAA System BA28-70/I20-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00818009012623), received between Jun 3, 2016 and Oct 18, 2022 — classified as 1 death, 9 injuries.

The most frequently reported specific device problem is “Leak/Splash” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2022Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT, AN INFRARENAL AORTIC EXTENSION A SUPRARENAL AORTIC EXTENSION AND AN OVATION IX EXTENDER 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 FIVE AND HALF (5.5) YEARS POST INITIAL PROCEDURE, THE LEFT COMMON ILIAC ARTERY WAS FOUND TO MEASURE 3.5CM AND THE AFX LIMB HAS EXPANDED TO GREATER THAN 30MM. TYPE 3B, TYPE 3A AND TYPE 1B ENDOLEAKS WERE IDENTIFIED. THE PATIENT IS ASYMPTOMATIC AND CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Failure of Implant

  MAUDE report 15629549 ↗
• InjuryJul 22, 2022Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, A TYPE 3A ENDOLEAK WITH JUNCTIONAL SEPARATION AND ANEURYSM ENLARGEMENT WAS IDENTIFIED AFTER THE PATENT UNDERWENT A COMPUTED TOMOGRAPHY (CT) SCAN. A RE-INTERVENTION WAS DONE, AND THE PHYSICIAN ELECTED TO IMPLANT (2) TWO AFX VELA INFRARENALS. IT WAS CONFIRMED THAT THE ENDOLEAK WAS RESOLVED, AND THE FINAL PATIENT STATUS WAS REPORTED AS BEING STABLE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 15086059 ↗
• InjuryApr 8, 2019Off-Label Use; Material Puncture/Hole; Material Integrity Problem; Off-Label Use; Material Puncture/Hole; Material Integrity Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A TYPE 3B ENDOLEAK WAS REPORTED. AS OF THE DATE OF THIS REPORT, AN INTERVENTIONS HAS NOT BEEN SCHEDULED AND THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8493915 ↗
• InjuryNov 29, 2018Partial Blockage; Leak/Splash; Material Puncture/Hole; Material Integrity Problem; Separation Problem; Partial Blockage; Leak/Splash; Material Puncture/Hole; Material Integrity Problem; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A TYPE 3B ENDOLEAK WAS REPORTED. A SECONDARY PROCEDURE WAS COMPLETED. THE PHYSICIAN ELECTED TO DO AN OPEN REPAIR AND EXPLANT THE PREVIOUSLY IMPLANTED DEVICES. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 8118166 ↗
• InjuryDec 6, 2017Failure To Adhere Or Bond; Detachment Of Device Component; Leak/Splash; Detachment of Device or Device Component; Failure To Adhere Or Bond; Detachment Of Device Component; Leak/Splash; Detachment of Device or Device Component

  ON (B)(6) 2015, THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL EXTENSION. ON (B)(6) 2017, THE DEVICES WERE EXPLANTED DUE TO A RUPTURE AND TYPE 3A ENDOLEAK WITH SEPARATION. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Aneurysm; Blood Loss; Failure of Implant; Pain; Rupture

  MAUDE report 7086959 ↗
• InjuryOct 5, 2017Failure To Adhere Or Bond; Leak/Splash; Material Integrity Problem; Failure To Adhere Or Bond; Leak/Splash; Material Integrity Problem

  ON (B)(6) 2015, THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A VELA SUPRARENAL EXTENSION. ON (B)(6) 2017 A TYPE 3B ENDOLEAK WITH CUFF MIGRATION OF 20 MM WAS DISCOVERED. ON (B)(6) 2017 THE PHYSICIAN ELECTED TO RE-LINE THE INITIAL DEVICES AND IMPLANTED A BIFURCATED STENT AND CUFF/ EXTENSION TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING FINE POST- SECONDARY.

  Patient problems: Failure of Implant

  MAUDE report 6915361 ↗
• DeathAug 30, 2017Hole In Material; Leak/Splash; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Hole In Material; Leak/Splash; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT, A SUPRARENAL AORTIC EXTENSION AND TWO LIMB EXTENSIONS. ON (B)(6) 2016 THE PATIENT HAD A SECONDARY PROCEDURE TO REPAIR A TYPE 3A ENDOLEAK WITH COMPONENT SEPARATION OF BOTH ILIAC LIMBS. THE PHYSICIAN IMPLANTED TWO ADDITIONAL LIMB EXTENSIONS TO RESOLVE THE ENDOLEAK. AT THE COMPLETION OF THE INVESTIGATION THE EVENT WAS CONFIRMED IN ADDITION A TYPE 2 ENDOLEAK WAS OBSERVED AT THE END OF THE SECONDARY PROCEDURE. ON (B)(6) 2017 IT WAS REPORTED THE PATIENT CAME IN EMERGENTLY AND BEFORE THE PATIENT WAS ABLE TO RECEIVE A COMPUTED TOMOGRAPHY (CT) SCAN THE PATIENT EXPIRED. THE PHYSICIAN IS SUSPECTING A POSSIBLE TYPE 3B ENDOLEAK.

  Patient problems: Death; Failure of Implant; Hemorrhage/Blood Loss/Bleeding; Pain; Shock

  MAUDE report 6831839 ↗
• InjuryJun 30, 2017Hole In Material; Adverse Event Without Identified Device or Use Problem; Hole In Material; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION. A ROUTINE FOLLOW UP COMPUTED TOMOGRAPHY (CT) SHOWED ANEURYSM SAC GROWTH WITH NO ENDOLEAK VISIBLE. THE PHYSICIAN IS PLANNING A SECONDARY INTERVENTION. THE PATIENT HAS NOT HAD A SECONDARY INTERVENTION AND IS CURRENTLY REPORTED TO BE IN GOOD CONDITION. THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

  Patient problems: Aneurysm

  MAUDE report 6682761 ↗
• InjuryJul 16, 2016Failure To Adhere Or Bond; Detachment Of Device Component; Leak/Splash; Failure To Adhere Or Bond; Detachment Of Device Component; Leak/Splash

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED DEVICE, A SUPRARENAL AORTIC EXTENSION AND TWO LIMB EXTENSIONS ON (B)(6) 2015. ON (B)(6) 2016 A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SHOWED A POTENTIAL TYPE 3B ENDOLEAK AND A POSSIBLE 1B ENDOLEAK. THE PHYSICIAN WAS ABLE TO CONFIRM THE PATIENT HAD A TYPE 3A ENDOLEAK WITH COMPONENT SEPARATION BETWEEN THE LIMB EXTENSION AND THE BIFURCATED MAIN BODY GRAFT. THE PHYSICIAN ELECTED TO IMPLANT TWO LIMB EXTENSIONS IN THE LEFT COMMON EXTERNAL ILIAC TO SEAL THE ENDOLEAK. THE PATIENT IS STABLE.

  Patient problems: Failure of Implant

  MAUDE report 5800847 ↗
• InjuryJun 3, 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 AND LIMB STENT GRAFT. SUBSEQUENTLY, THE PHYSICIAN NOTED ON (B)(6) 2016 A TYPE 1A OR TYPE 1B LEAK WITH SAC GROWTH. THE LEAKS WERE NOT OFFICIALLY DETERMINED, BUT THE SAME DAY, THE PHYSICIAN DECIDED TO IMPLANT A LIMB STENT GRAFT TO SEAL THE LEAK. THE PATIENT WAS FINE AFTER PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 5697769 ↗

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-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-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-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-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-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• 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-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-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• 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-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.