AFX2 Bifurcated Endograft System BEA28-70/I16-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00818009014603), received between May 8, 2018 and May 14, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2026Detachment of Device or Device Component; Separation Problem

  THE PATIENT WAS TREATED FOR A FUSIFORM ANEURYSM WITH TWO SACS AND A SLIGHTLY ANGULATED NECK WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT(BSG) AND AN AFX VELA SUPRARENAL ON (B)(6) 2019. ON (B)(6) 2026 THE PHYSICIAN REPORTED THAT UNCOUPLING BETWEEN THE AFX2 BSG AND THE VELA SUPRARENAL WAS CONFIRMED. FURTHERMORE, THE BARE STENT PORTION OF THE VELA SUPRARENAL WAS FOUND TO BE PARTIALLY DETACHED FROM THE GRAFT, SUGGESTING POTENTIAL DAMAGE. AN INTERVENTION USING DEVICES FROM ANOTHER MANUFACTURER IS PLANNED FOR AN UNKNOWN DATE.

  Patient problems: Clinical Endoleak

  MAUDE report 25178663 ↗
• InjuryNov 5, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL STENT GRAFT FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2019. APPROXIMATELY FIVE YEARS AFTER THE INITIAL PROCEDURE, DURING A FOLLOW-UP ON (B)(6) 2024, IT WAS DISCOVERED THAT THE JUNCTION BETWEEN THE MAIN BODY AND THE VELA HAD SEPARATED. THE ANEURYSM HAD NOT ENLARGED DUE TO THE PRESENCE OF A MURAL THROMBUS. THE TREATMENT PLAN FOR THIS ISSUE IS CURRENTLY UNDER DISCUSSION.

  Patient problems: Clinical Endoleak

  MAUDE report 20608861 ↗
• InjuryOct 18, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING THE INITIAL IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AFX INFRARENAL AORTIC EXTENSION, INTRAOPERATIVE TYPE IA, IIIA AND IIIB ENDOLEAKS WERE REPORTED. THE PATIENT FIRST HAD A GORE (NON-ENDOLOGIX) EXCLUDER DEVICE IMPLANTED IN THE COMMON ILIAC ARTERY. THE AFX2 BIFURCATED STENT GRAFT AND AFX INFRARENAL AORTIC EXTENSION WERE THEN IMPLANTED. AN ANGIOGRAM AFTER BALLOON TOUCH-UP SHOWED A TYPE IA ENDOLEAK, AND THEREFORE A SECOND GORE(NON-ENDOLOGIX) EXCLUDER WAS IMPLANTED TO RESOLVE THIS LEAK. A TYPE IIIA ENDOLEAK WAS THEN CONFIRMED FROM THE LEFT SIDE, AND THUS A THIRD GORE (NON-ENDOLOGIX) EXCLUDER WAS ADDED TO RESOLVE THIS LEAK. ANOTHER ENDOLEAK WAS OBSERVED ABOVE THE TERMINAL AORTA, AND IT WAS SUSPECTED AS A TYPE IIIB ENDOLEAK. ADDITIONAL INTERVENTION WAS NOT PERFORMED AT THE TIME, AND THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. NOTE: THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX SYSTEM PER DEVICE IFU. THIS EVENT WAS PREVIOUSLY REPORTED PER MFR. REPORT # 2031527-2020-00080. APPROXIMATELY TWO AND A HALF (2.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A POSSIBLE TYPE II ENDOL

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 15621561 ↗
• InjuryNov 24, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, UNKNOWN REINTERVENTION WAS PERFORMED TO TREAT A TYPE II ENDOLEAK (NON-DEVICE RELATED). APPROXIMATELY TWO (2) YEARS POST-REINTERVENTION COMPUTERIZED TOMOGRAPHY ANGIOGRAM IDENTIFIED THAT THE ANEURYSM SAC CONTINUES TO EXPAND AND THAT THERE IS A POSSIBLE TYPE 3B ENDOLEAK IN THE DISTAL BODY OF THE AFX2 BIFURCATED STENT GRAFT. THERE IS A NEW SMALL TYPE II ENDOLEAK AS WELL. ADDITIONAL ANGIOGRAM IS PLANNED WITH A POSSIBLE RE-LINE OF THE DEVICE; HOWEVER, IT IS NOT YET SCHEDULED. THE PATIENT IS REPORTED TO BE STABLE. SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION WAS PROVIDED REPORTING THAT REINTERVENTION WAS COMPLETED WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. AN ANGIOGRAM WAS NOT PERFORMED DUE TO RENAL FUNCTION; HOWEVER, BASED ON THE CT (COMPUTED TOMOGRAPHY) SCAN IT IS ASSUMED THAT IT WAS A TYPE 3B ENDOLEAK. THE TYPE 3B ENDOLEAK WAS SUCCESSFULLY SEALED POST RE-LINE. THE FINAL PATIENT STATUS WAS REPORTED TO BE STABLE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12870845 ↗
• InjuryMay 7, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA INFRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE YEAR AND A HALF POST INITIAL PROCEDURE ONGOING STENOSIS 50 TO 75% OF THE RIGHT LIMB OF THE GRAFT AND 75% STENOSIS OF THE MID GRAFT OF THE LEFT ILIAC WAS IDENTIFIED. AN INTERVENTION WAS COMPLETED, AND THE LEFT COMMON AND EXTERNAL ILIAC ARTERIES WERE TREATED WITH 12MM BALLOON ON (B)(6) 2020. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Stenosis

  MAUDE report 11791155 ↗
• InjuryApr 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE,THE PATIENT WAS IDENTIFIED WITH A 1B ENDOLEAK DURING A ROUTINE FOLLOW UP. THE PHYSICIAN IMPLANTED A LIMB STENT GRAFT EXTENSION TO TREAT THE LEAK. THE LEAK WAS RESOLVED AND PATIENT STATUS IS GOOD.

  Patient problems: Failure of Implant

  MAUDE report 11694216 ↗
• InjurySep 29, 2020Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL STENT GRAFT EXTENSION, A NON-ENDOLOGIX DEVICE (EXCLUDER CUFF) AND A NON-ENDOLOGIX SMART BARE METAL STENT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS 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 2 YEARS LATER, A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED JUNCTION SEPARATION AND A TYPE 3A ENDOLEAK. THE PHYSICIAN COMPLETED A SUCCESSFUL REINTERVENTION AND RELINED THE EXISTING STENT GRAFTS WITH A VELA INFRARENAL STENT GRAFT EXTENSION AND AN ADDITIONAL EXCLUDER CUFF. THE ENDOLEAK WAS RESOLVED AND NO PATIENT HARM WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 10600144 ↗
• InjuryApr 8, 2020Patient-Device Incompatibility; Insufficient Device Problem Information; Separation Problem; Patient-Device Incompatibility; Insufficient Device Problem Information; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY 3 (THREE) YEARS LATER THE PATIENT PRESENTED FOR ROUTINE FOLLOW UP AND A TYPE 3A WAS IDENTIFIED ON A DOPPLER US. PATIENT CONDITION WAS REPORTED AS STABLE AND A RE-INTERVENTION HAS BEEN SCHEDULED. SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT DETERMINED THE TYPE IIIA ENDOLEAK INCLUDED COMPLETE COMPONENT SEPARATION WHICH WAS NOT INCLUDED IN THE EVENT AS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9935287 ↗
• InjuryMar 2, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DURING THE INITIAL IMPLANTATION OF THE AN AFX2 BIFURCATED STENT GRAFT AND SUPRARENAL PROXIMAL EXTENSION, AN INTRAOPERATIVE 1A, 3B AND 3A ENDOLEAKS WERE REPORTED. THE PATIENT HAD A NON- ENDOLOGIX (GORE/ EXCLUDER LEG) STENT IMPLANTED IN THE COMMON ILIAC ARTERY FIRST. THIS IS OUTSIDE THE OUTSIDE THE INDICATIONS OF USE DUE TO THE USE OF NON- ENDOLOGIX DEVICES. THE AFX2 BIFURCATED STENT GRAFT AND THE SUPRARENAL PROXIMAL EXTENSION WAS THEN IMPLANTED. AN ANGIOGRAM AFTER BALLOON TOUCH-UP SHOWED A TYPE IA ENDOLEAK; THEREFORE, A NON- ENDOLOGIX (GORE/ EXCLUDER CUFF) STENT WAS IMPLANTED TO RESOLVE THIS LEAK. A TYPE 3A ENDOLEAK WAS CONFIRMED FROM THE LEFT SIDE. A NON- ENDOLOGIX (GORE/ EXCLUDER LEG) STENT WAS ALSO ADDED TO RESOLVE THIS LEAK. ANOTHER ENDOLEAK WAS OBSERVED ABOVE THE TERMINAL AORTA, AND IT WAS SUSPECTED AS A TYPE 3B ENDOLEAK. ADDITIONAL INTERVENTION WAS NOT PERFORMED, AND THE PATIENT WILL BE MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 9777821 ↗
• InjuryAug 22, 2018Loss of or Failure to Bond; Leak/Splash; Detachment of Device or Device Component; Loss of or Failure to Bond; Leak/Splash; Detachment of Device or Device Component

  THE PATIENT WAS INITIALLY TREATED WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT ON (B)(6) 2016. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, A MAIN BODY-TO-PROXIMAL EXTENSION SEPARATION WAS DETECTED BY CT ON AN UNKNOWN DATE, WHICH HAS BEEN DEFAULTED TO (B)(6) 2018; ENDOLOGIX BECAME AWARE OF THE REPORTED PRODUCT PROBLEM ON (B)(6) 2018. THE PHYSICIAN PLANS TO SCHEDULE THE PATIENT FOR RE-INTERVENTION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7804542 ↗
• InjuryJul 9, 2018Disconnection; Leak/Splash; Migration or Expulsion of Device; Disconnection; Leak/Splash; Migration or Expulsion of Device

  PRIMARY PROCEDURE WAS PERFORMED ON (B)(6) 2016. THE PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED STENT AND AN AFX VELA SUPRARENAL. ON (B)(6) 2018, THE PATIENT PRESENTED EMERGENTLY WITH AN ENDOLEAK TYPE 3A. REPORTEDLY, THE PHYSICIAN NOTED IT APPEARED THAT THE GRAFT MIGRATED (LOST OVERLAP), AND EVENTUALLY DISCONNECTED. DURING THE WEEK OF (B)(6) 2018 (THE EXACT DATE WAS NOT PROVIDED) THE PATIENT WAS RELINED WITH A NON-ENDOLOGIX DEVICE. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 7669885 ↗
• InjuryMay 8, 2018Leak/Splash; Biocompatibility; Leak/Splash; Biocompatibility

  ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE OF A PATIENT WITH A CONTINUED SAC GROWTH, AN INDETERMINATE ENDOLEAK (POSSIBLE TYPE 1A/3A), AND POSSIBLE INFECTION. PHYSICIAN IS PLANNING ON DOING A REPAIR, BUT NO CONFIRMED DATE HAS BEEN PROVIDED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Aneurysm; Failure of Implant; Unspecified Infection

  MAUDE report 7497205 ↗

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-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-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-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-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-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-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
• 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-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-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

…and 1 more.