AFX2 Bifurcated Endograft System BEA25-110/I20-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00818009014818), received between Mar 26, 2019 and Nov 22, 2024 — classified as 1 death, 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2024Off-Label Use; Unintended Movement; Separation Problem; Off-Label Use; Unintended Movement; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2018 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AFX VELA SUPRARENAL AND OVATION IX ILIAC LIMB. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) AS THE SAFETY AND EFFECTIVENESS OF OTHER STENT OR STENT GRAFT DEVICES USED IN CONJUNCTION WITH THE AFX2 SYSTEM HAVE NOT BEEN ESTABLISHED. APPROXIMATELY 6 ½ YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY ON (B)(6) 2024 WITH A RUPTURED AORTA. REPORTEDLY THERE MAY HAVE BEEN A CONSISTENT TYPE II ENDOLEAK WHICH CAUSED CONTINUED ANEURYSM GROWTH WHICH IN TURN MAY HAVE LED TO LATERAL DISPLACEMENT OF THE GRAFT LEAVING ONLY 3 CM OF OVERLAP THEREFORE CAUSING A POSSIBLE TYPE IIIA ENDOLEAK. REINTERVENTION WAS COMPLETED ON (B)(6) 2024 WITH THE IMPLANT OF TWO (2) AFX VELA SUPRARENALS. PATIENT WAS REPORTED AS DOING WELL, EXTUBATED AND RECOVERING.

  Patient problems: Clinical Endoleak; Low Blood Pressure/ Hypotension; Ruptured Aneurysm

  MAUDE report 20758541 ↗
• InjuryApr 23, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2023, WITH THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL, AND AN AFX VELA SUPRARENAL. IT WAS REPORTED ON (B)(6) 2024, THAT THE PATIENT UNDERWENT A RE-INTERVENTION FOR AN ENDOLEAK TYPE IB. THE PHYSICIAN IMPLANTED AN ADDITIONAL AFX2 BIFURCATED STENT GRAFT AND AN OVATION IX EXTENDER. THE FINAL PATIENT STATUS WAS REPORTED AS DOING WELL WITH NO PRESENCE OF AN ENDOLEAK.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19169591 ↗
• InjuryAug 2, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT AND AN AFX VELA SUPRARENAL. APPROXIMATELY A YEAR AND A HALF (1.5) POST INITIAL PROCEDURE, THE PATIENT WAS IDENTIFIED WITH A TYPE 1A ENDOLEAK. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF TWO (2) ADDITIONAL AFX VELA SUPRARENALS. IT WAS REPORTED THAT THE 1A ENDOLEAK WAS RESOLVED AFTER THE SECONDARY PROCEDURE. THE FINAL PATIENT STATUS WAS REPORTED AS DOING FINE.

  Patient problems: Clinical Endoleak

  MAUDE report 17445435 ↗
• InjuryMay 10, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) MONTHS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED A TYPE 1B ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT THREE (3) OVATION ILIAC EXTENDERS TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING WELL POST SECONDARY PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 11803291 ↗
• InjuryMar 16, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A AFX2 BIFURCATED STENT GRAFT, AND A VELA SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 3.5 YEARS POST INITIAL IMPLANT, THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED ANEURYSM. THE PHYSICIAN ELECTED TO PREFORM AN OPEN REPAIR/ EXPLANT TO RESOLVE THIS EVENT. REPORTEDLY, THE PATIENT WAS IN A MOVING VEHICLE ACCIDENT (MVA) AND THE PHYSICIAN BELIEVES THE ACCIDENT MAY HAVE PLAYED A PART IN THE RUPTURED ANEURYSM.

  Patient problems: Aneurysm; Failure of Implant; Rupture

  MAUDE report 11499669 ↗
• InjurySep 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE (1) YEAR LATER, THE PATIENT PRESENTED EMERGENTLY WITH SYMPTOMS OF RUPTURE AND A 1B ENDOLEAK OF THE RIGHT COMMON ILIAC ARTERY WAS IDENTIFIED. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT AN OVATION IX EXTENDER TO RESOLVE THIS REPORTED EVENT. THE PATIENT WAS REPORTED AS STABLE POST INTERVENTION AND WILL CONTINUED TO BE MONITORED.

  Patient problems: Aneurysm; Failure of Implant; Rupture

  MAUDE report 10538900 ↗
• DeathJun 25, 2020Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Improper or Incorrect Procedure or Method; Device Damaged by Another Device

  THE PATIENT WAS BEING IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH A CONTAINED RUPTURE. DURING THE PROCEDURE, DUE TO ABNORMAL THROMBUS OF THE AORTA (THIS IS OUTSIDE OF THE RECOMMENDED ANATOMICAL CHARACTERISTICS LISTED IN THE IFU) THE CONTRA LIMB OF THE AFX2 BIFURCATED STENT GRAFT BECAME SLIGHTLY WRAPPED AND IT COULD NOT BE RESOLVED. AFTER DEPLOYMENT OF THE CONTRA LIMB OF THE AFX2 THE DISTAL PORTION OF THE GRAFT WAS NARROWED; THEREFORE, BALLOONING WAS PERFORMED WITH A 10X40 BALLOON. WHILE ADVANCING AN OMNI FLUSH (NON-ENDOLOGIX) CATHETER TO REMOVE THE CONTRA WIRE, THE CONTRA LIMB WAS PUSHED INTO THE MAIN BODY. AN ATTEMPT WAS MADE WITH THE BALLOON TO PULL THE CONTRA LIMB BACK DOWN; HOWEVER, THE LIMB ADVANCED FURTHER PROXIMAL. THE PHYSICIAN ELECTED TO STOP THE PROCEDURE. FINAL PATIENT STATUS WAS NOT REPORTED. THE PATIENT IS BEING MONITORED. SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLE SUGGEST THAT PATIENT PRESENTED WITH AN AORTIC RUPTURE WITH LARGE RETROPERITONEAL HEMATOMA, AND THAT THE PATIENT EXPIRED ON (B)(6) 2020, DUE TO THE AORTIC ANEURYSM RUPTURE THAT WAS NOT INCLUDED IN TH

  Patient problems: Aneurysm; Death; Failure of Implant; Rupture; Thrombus

  MAUDE report 10196559 ↗
• InjuryMay 17, 2019Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, AN INFRARENAL STENT GRAFT EXTENSION AND TWO (2) LIMB STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). DURING THIS INITIAL PROCEDURE, THE CONTRALATERAL WIRE COVER BECAME WRAPPED AROUND THE IPSILATERAL LIMB OF THE BIFURCATED STENT GRAFT. THE PHYSICIAN SPENT ONE (1) HOUR ATTEMPTING TO RESOLVE THE ISSUE WITHOUT SUCCESS. THE PHYSICIAN DECIDED TO FORM AN UNIBODY GRAFT. THIS IS OUTSIDE THE INDICATIONS OF USE (OFF- LABEL). DURING THIS PROCESS, THE LEFT COMMON ILIAC ARTERY (LCIA) RUPTURED. IT WAS REPORTED THAT LOCAL DISSECTION WAS PRESENT PRIOR TO PROCEDURE. THE PHYSICIAN DECIDED TO PROCEED WITH OPEN SURGERY. THE PATIENT WAS REPORTED AS DOING WELL.

  Patient problems: Rupture; Vascular Dissection

  MAUDE report 8621459 ↗
• InjuryMar 26, 2019Material Puncture/Hole; Product Quality Problem; Use of Device Problem; Material Integrity Problem; Material Puncture/Hole; Product Quality Problem; Use of Device Problem; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED PER CLINICAL ASSESSMENT ALSO CONFIRMING THE PRESENCE OF A TYPE II ENDOLEAK AT THE TIME OF THE REPORTED EVENT. IN ADDITION, CLINICAL IDENTIFIED THAT A LEFT SIDE NON-ENDOLOGIX STENT WAS IMPLANTED AT THE TIME OF THE INITIAL CASE.

  Patient problems: Failure of Implant

  MAUDE report 8453489 ↗

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-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-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-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-0592-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• 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-0590-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• 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-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-0593-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL

…and 1 more.