AFX2 Bifurcated Endograft System BEA25-120/I16-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00818009014719), received between Nov 8, 2016 and May 19, 2026 — classified as 1 death, 8 injuries, 1 malfunction.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2019 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL. IT WAS REPORTED ON 23 APRIL 2026 THAT THERE IS A POSSIBLE ENDOLEAK. REINTERVENTION WAS COMPLETED ON (B)(6) 2026. DURING REINTERVENTION IT WAS CONFIRMED THAT THE POSSIBLE ENDOLEAK WAS A TYPE IIIB ENDOLEAK. THE INITIALLY IMPLANTED AFX2 BIFURCATED STENT GRAFT WAS RELINED WITH A NEW AFX2 BIFURCATED STENT GRAFT. THE TYPE IIIB ENDOLEAK WAS RESOLVED AND PATIENT IS DOING WELL.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 25217968 ↗
• InjuryAug 19, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG) AND AN AFX VELA SUPRARENAL. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, THE PATIENT PRESENTED WITH BOTH DEVICES GETTING VERY CLOSE TO SEPARATING. THE PHYSICIAN IS UNABLE TO DETERMINE WHETHER THERE IS A TYPE III ENDOLEAK ON THE COMPUTED TOMOGRAPHY SCAN. INTERVENTION OCCURRED ON (B)(6) 2025 WITH THE IMPLANT OF AN ALTO STENT GRAFT SYSTEM. THE PATIENT WAS REPORTED AS DOING FINE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 22845794 ↗
• InjuryJul 10, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  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 THREE YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A TYPE IB ENDOLEAK FROM THE RIGHT SIDE APPEARED ON THE COMPUTED TOMOGRAPHY ANGIOGRAPHY. THE PHYSICIAN ELECTED TO ADD AN OVATION IX EXTENDER ON THE RIGHT SIDE. IT WAS ALSO NOTED THAT THE PROXIMAL CUFF HAD DROPPED DOWN OR LANDED 1 CM TOO LOW. THE PHYSICIAN ELECTED TO EXTEND UP TO THE RENALS AND PLACE A BRIDGE PIECE SO AN AFX VELA SUPRARENAL CUFF AND AN AFX VELA INFRARENAL CUFF WERE PLACED FOR OVERLAP. THE ENDOLEAK WAS RESOLVED AND THE PATIENT WAS REPORTED AS BEING STABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 22470483 ↗
• InjuryOct 17, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX LIMB STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (1) ONE-YEAR POST INITIAL PROCEDURE, AN ENDOLEAK (INDETERMINATE ORIGIN) WAS IDENTIFIED. THE BIFURCATED STENT GRAFT ALSO SHOWED AS COLLAPSED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN, AND IT IS UNKNOWN IF THE PHYSICIAN PLANS TO RE-INTERVENE.

  Patient problems: Failure of Implant

  MAUDE report 15620290 ↗
• InjuryFeb 23, 2021Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A POSSIBLE TYPE 1A OR 1B ENDOLEAK, AND A TYPE 3B ENDOLEAK WERE IDENTIFIED. PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Failure of Implant

  MAUDE report 11368981 ↗
• InjuryFeb 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN INFRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE AND A HALF (1.5) YEARS POST INITIAL PROCEDURE, A TYPE 1A ENDOLEAK AND A TYPE 2 ENDOLEAK (NON- DEVICE FAILURE) WERE IDENTIFIED. REPORTEDLY, THE PHYSICIAN WAS PLANNING TO PERFORM AN OPEN REPAIR HOWEVER NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT'S NECK ANATOMY WAS CONSIDERED OFF- LABEL. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MDR # 2031527-2018-00937. NOW, APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PHYSICIAN REPORTED A SMALL ENDOLEAK OF AN INDETERMINATE ORIGIN. PATIENT IS CURRENTLY BEING MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 11263580 ↗
• InjuryFeb 6, 2020Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH A BIFURCATED STENT GRAFT, A SUPRARENAL EXTENSION AND AN OVATION LIMB EXTENSION. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF -LABEL) DUE TO CONCOMITANT USE WITH PRODUCTS OUTSIDE THE IFU. APPROXIMATELY FIVE (5) MONTHS POST INITIAL PROCEDURE (THE EXACT DATE OF EVENT WAS NOT PROVIDED), CLOTS IN THE GRAFTS WERE IDENTIFIED BY A COMPUTED TOMOGRAPHY ANGIOGRAM (CTA). THE PHYSICIAN ELECTED TO REFER THE PATIENT ANOTHER PHYSICIAN FOR TREATMENT. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Occlusion

  MAUDE report 9678879 ↗
• InjuryOct 30, 2019Material Puncture/Hole; Use of Device Problem; Improper or Incorrect Procedure or Method; Material Puncture/Hole; Use of Device Problem; Improper or Incorrect Procedure or Method

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT. DURING THE INITIAL PROCEDURE, THE BIFURCATED DEVICE WAS POST-DILATED AND THE GRAFT EXPANDED QUICKLY, WHICH RESULTED IN A FABRIC TEAR (TYPE IIIB ENDOLEAK). THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING WITH AN ADDITIONAL BIFURCATED DEVICE. THE TYPE IIIB ENDOLEAK WAS CONFIRMED RESOLVED, BUT A POSSIBLE TYPE II ENDOLEAK REMAINED. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. ADDITIONAL INFORMATION: THE PATIENT WAS DISCHARGED POST OPERATIVE DAY FIVE (5) IN STABLE CONDITION FOLLOWING ENDOVASCULAR PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 9255111 ↗
• MalfunctionJan 4, 2019Material Deformation; Material Deformation

  AN AFX2 BIFURCATED WAS INITIALLY IMPLANTED. THE 11 MONTH ROUTINE FOLLOW-UP SHOWS EVIDENCE OF KINKING OF THE AFX BIFURCATED DEVICE. THE PATIENT IS REPORTED AS ASYMPTOMATIC AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8220438 ↗
• DeathNov 8, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT WITH A SEVERELY DISTENDED ABDOMEN CAME IN EMERGENTLY ON (B)(6) 2016 WITH A RUPTURED AORTIC ANEURYSM THAT WAS LEAKING A SIGNIFICANT AMOUNT OF BLOOD INTO THE RETROPERITONEUM. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING A BIFURCATED STENT, AN INFRARENAL AORTIC EXTENSION, AND A SUPRARENAL AORTIC EXTENSION. AT THE COMPLETION OF THE IMPLANT THE PHYSICIAN WAS CONCERNED WITH COMPARTMENT SYNDROME, THE SIGNIFICANT AMOUNT OF BLOOD LOSS, AS WELL AS THE PROLONGED BALLOONING OF THE AORTIC VESSELS; THE PHYSICIAN HAD TO EXPLANT THE DEVICES. THE PHYSICIAN COMPLETED AN OPEN REPAIR HOWEVER, THE PATIENT EXPIRED ON (B)(6) 2016, DUE TO SIGNIFICANT BLOOD LOSS.

  Patient problems: Blood Loss; Death; Patient Problem/Medical Problem

  MAUDE report 6087173 ↗

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-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-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-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-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-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-0590-06 · 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.