AFX2 Bifurcated Endograft System BEA25-80/I16-55Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818009014924), received between Sep 22, 2016 and Mar 3, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2026Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL AORTIC EXTENSION, AN OVATION EXTENDER AND TWO (2) OVATION IX ILIAC LIMB STENT GRAFTS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). NOTE: THE AFX2 SYSTEM WAS EVALUATED USING ENDOLOGIX COMPONENTS. THE SAFETY AND EFFECTIVENESS OF OTHER STENT GRAFT DEVICES USED IN CONJUNCTION WITH THE AFX2 SYSTEM HAVE NOT BEEN ESTABLISHED. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, AN UNDETERMINED TYPE OF TYPE 3 ENDOLEAK WAS IDENTIFIED. IT WAS DIFFICULT TO VISUALIZE WHAT IS HAPPENING DUE TO COILS IN THE LEFT COMMON ILIAC ARTERY; HOWEVER, THE ANEURYSM IS CURRENTLY LESS THAN 5CM. UPON FURTHER EVALUATION OF THE PATIENT WITH A FOLLOW UP ANGIOGRAM THERE WAS NO SIGN OF ANY ENDOLEAK; THEREFORE, NO INTERVENTION WAS DONE. ON (B)(6) 2026, THE PATIENT PRESENTED AT THE PHYSICIAN¿S OFFICE IN A NON-EMERGENT SETTING. UPON EVALUATION, AN ENDOLEAK WAS SUSPECTED AND THE PATIENT WAS SCHEDULED FOR AN ANGIOGRAM AND POTENTIAL RE-LINING. UPON COMPLETION OF THE ANGIOGRAM, IT WAS NOTED THERE WAS A TYPE 3B ENDOLEAK. THE PHYSICIAN ELECTED TO RE-LINE THE PREVIOUSLY IMPLANTED AFX2 STENT GRAFT WITH A NEW AFX2 BIFURCATED STENT GRAFT AN

  Patient problems: Clinical Endoleak

  MAUDE report 24503142 ↗
• InjuryOct 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND INFRARENAL STENT TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY, 5 YEARS POST-OPERATIVE A CT IDENTIFIED A TYPE IIIB ENDOLEAK AND PHYSICIAN ELECTED TO RELINE WITH A BIFURCATED STENT GRAFT AND 2 INFRARENAL STENTS. THIS WAS PREVIOUSLY REPORTED UNDER 2031527-2017-00494. NOW, APPROXIMATELY 1.5 YEARS POST SECONDARY PROCEDURE, THE SAC GROWTH WAS IDENTIFIED. THE PHYSICIAN ELECTED TO UNDERGO AN OPEN EXPLORATION. NO BLOOD OR LEAKS WERE VISIBLE BUT A THIN YELLOW FLUID WAS EVACUATED (NO SMELL AND C & S WAS NEGATIVE). ULTIMATELY A PORTION OF THE AORTA WAS RESECTED AND REST CLOSED BACK DOWN AROUND THE INTACT GRAFTS. THE PATIENT WAS REPORTED AS DOING EXTREMELY WELL.

  Patient problems: Aneurysm

  MAUDE report 9263856 ↗
• InjurySep 22, 2016Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED DEVICE, AN INFRARENAL AORTIC EXTENSION, AND FIVE OVATION LIMB EXTENSIONS ON (B)(6) 2016. AFTER IMPLANTING THE LIMB EXTENSIONS ON THE LEFT SIDE IT WAS DISCOVERED THERE WAS A POOR SEAL BETWEEN THE BIFURCATED STENT AND THE OVATION LIMB. THE PHYSICIAN ATTEMPTED TO BALLOON THE AREA AND IT WAS UNSUCCESSFUL AT SEALING THE LEAK. FOLLOWING THE INITIAL PROCEDURE THE PHYSICIAN STILL IDENTIFIED A TYPE 3A ENDOLEAK BETWEEN THE AFX MAIN BODY AND THE OVATION LIMB EXTENSION ON THE LEFT SIDE. THE PHYSICIAN ELECTED TO SCHEDULE A SECONDARY PROCEDURE TO SEAL THE REMAINING TYPE 3A ENDOLEAK. ON (B)(6) 2016 THE PHYSICIAN ELECTED TO IMPLANT A NON-ENDOLOGIX STENT TO SEAL THE AREA BETWEEN THE MAIN BODY AND THE OVATION LIMB EXTENSION, THE LEAK PERSISTED. AN ADDITIONAL BIFURCATED DEVICE AND AN ADDITIONAL AFX LIMB EXTENSION WAS THEN IMPLANTED TO RELINE THE ORIGINAL STENTS AND SEAL THE ENDOLEAK. PATIENT IS STABLE.

  Patient problems: Failure of Implant

  MAUDE report 5969075 ↗

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-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-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-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-0593-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• 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-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• 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-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• 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-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL

…and 1 more.