AFX Endovascular AAA System BA25-80/I16-55Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00818009010070), received between Mar 18, 2016 and Jan 28, 2021 — classified as 1 death, 4 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A RUPTURE CAUSED BY A TYPE 3B ENDOLEAK. A SECONDARY PROCEDURE WAS COMPLETED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH ANOTHER BIFURCATED STENT GRAFT, A NON- ENDOLOGIX (GORE) LIMB STENT GRAFT AND ANOTHER NON- ENDOLOGIX (ICAST) STENT. THE 3B ENDOLEAK WAS RESOLVED; HOWEVER, THE PATIENT'S BLOOD PRESSURE WAS STILL NOT GOOD BECAUSE OF THE BLOOD IN THE ABDOMEN. THE PHYSICIAN ELECTED TO OPEN THE ABDOMEN TO RELIEVE THE PRESSURE AND MAKE SURE THE GRAFT WAS WORKING TO EXCLUDE THE RUPTURED AAA. THE PATIENT WAS CLOSED AND SENT TO THE INTENSIVE CARE UNIT.

  Patient problems: Failure of Implant; Rupture

  MAUDE report 11245773 ↗
• InjuryFeb 24, 2020Use of Device Problem; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Deformation Due to Compressive Stress; Insufficient Device Problem Information; Use of Device Problem; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Deformation Due to Compressive Stress; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION AND A LIMB STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 4.5 YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED AAA. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH A COOK ZENITH (NON-ENDOLOGIX) STENT. THE PATIENT WAS REPORTED AS STABLE AND IS RECOVERING. ADDITIONAL INFORMATION: DURING CLINICAL ASSESSMENT, SAC GROWTH OF 11.9MM, BUCKLING OF THE PROXIMAL EXTENSION, A TYPE IIIB ENDOLEAK OF THE BIFURCATED STENT GRAFT, AND A TYPE IIIA ENDOLEAK OF THE AORTIC COMPONENTS OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED.

  Patient problems: Aneurysm; Failure of Implant; Rupture

  MAUDE report 9747087 ↗
• InjuryFeb 14, 2020Material Puncture/Hole; Use of Device Problem; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Migration; Material Puncture/Hole; Use of Device Problem; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Migration

  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 PRESENTED AT ROUTINE FOLLOW-UP WITH A MIGRATED (BY 20MM) PROXIMAL STENT GRAFT EXTENSION AND A TYPE 3B ENDOLEAK OF THE BIFURCATED STENT GRAFT. A RE-INTERVENTION WAS PERFORMED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH OVATION IX ABDOMINAL STENT GRAFT SYSTEM (ONE MAIN BODY AND 4 ILIAC LIMBS) TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 9714952 ↗
• InjuryApr 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH A BIFURCATED STENT GRAFT, TWO VELA INFRARENALS, AND TWO LIMB STENT GRAFTS (IMPLANTING PHYSICIAN DR. (B)(6)). ON (B)(6) 2016, A SECONDARY PROCEDURE WAS PERFORMED FOR AN UNKNOWN REASON AND THE PATIENT WAS IMPLANTED WITH THREE ADDITIONAL LIMB STENT GRAFTS (IMPLANTING PHYSICIAN (B)(6)). NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Information

  MAUDE report 7443040 ↗
• DeathMar 18, 2016Failure To Adhere Or Bond; Failure To Adhere Or Bond

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A LIMB EXTENSION ON (B)(6) 2016. INITIAL IMPLANT OF THE STENT WAS DUE TO EMERGENT RUPTURE OF THE ILIAC ARTERY. A FOLLOW UP FOUND THE PATIENT HAD A TYPE 3A ENDOLEAK, THE PHYSICIAN ELECTED TO IMPLANT TWO ADDITIONAL LIMB EXTENSIONS TO SEAL THE ENDOLEAK. PATIENT PROCEDURE WAS SUCCESSFUL, PATIENT CONDITION IS UNSTABLE DUE TO EXISTING DISEASE PROGRESSION. AN UPDATE RECEIVED ON (B)(6) 2016 INDICATED THE PATIENT HAD EXPIRED. ACTUAL PATIENT DATE OF DEATH IS UNKNOWN.

  Patient problems: Death; Failure of Implant

  MAUDE report 5510955 ↗

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-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-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-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-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• Z-0596-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL
• 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-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-0593-06 · 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

…and 1 more.