AFX2 Bifurcated Endograft System BEA25-80/I13-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00818009014788), received between Aug 12, 2016 and Mar 27, 2023 — classified as 2 deaths, 11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, ANEURYSM ENLARGEMENT WAS IDENTIFIED DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION: AN INTERNAL CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST AN ACCESS SITE COMPLICATION AND ADDITIONAL SURGICAL PROCEDURE (RIGHT FEMORAL ENDARTERECTOMY AND BOVINE GRAFT) OCCURRED AT INDEX THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE ADDITIONAL SURGICAL PROCEDURE WAS DISCOVERED DURING REVIEW OF OPERATIVE NOTES DATED ON (B)(6) 2020. THE CLINICAL ASSESSMENT ALSO DETERMINED THAT A TYPE 1A ENDOLEAK OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE TYPE 1A ENDOLEAK WAS DISCOVERED DURING A REVIEW OF THE CT SCAN DATED ON (B)(6) 2022.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16619702 ↗
• InjuryDec 6, 2021Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, A TYPE 3A ENDOLEAK WITH COMPONENT SEPARATION WAS IDENTIFIED. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF AN AFX VELA INFRARENAL AND AN AFX VELA SUPRARENAL. THE PROCEDURE WAS COMPLETED WITH NO ENDOLEAKS. THE FINAL PATIENT STATUS WAS REPORTED TO BE STABLE.

  Patient problems: Failure of Implant

  MAUDE report 12934926 ↗
• InjuryOct 13, 2021Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT. REPORTEDLY, THE INDEX PLACEMENT WAS LOW. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE THE ROUTINE FOLLOW-UP IDENTIFIED A POSSIBLE TYPE I ENDOLEAK OR TYPE II ENDOLEAK (NON-DEVICE RELATED). THE PHYSICIAN PLANS TO RE-INTERVENE BUT SURGERY HAS NOT BEEN SCHEDULED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12624893 ↗
• InjuryDec 21, 2020Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE AND A HALF (3.5) YEARS POST INITIAL PROCEDURE, THERE WAS STENT GRAFT SEPARATION (CLASSIFIED AS A TYPE 3A ENDOLEAK). A SECONDARY PROCEDURE WAS COMPLETED. THE PHYSICIAN ELECTED TO BRIDGE THE SEPARATED STENT GRAFTS WITH TWO AORTIC EXTENSION STENT GRAFTS TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING FINE POST SECONDARY PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 11051927 ↗
• DeathNov 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 IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT POST OPERATIVELY AND UPON CLOSURE THE PATIENT SUFFERED A RETROPERITONEAL BLEED (CLASSIFIED AS A RUPTURE). THE CAUSE OF THE RUPTURE AND PATIENT'S CURRENT STATUS IS UNKNOWN. ADDITIONAL INFORMATION RECEIVED INDICATING THE PATIENT EXPIRED ON AN UNKNOWN DATE. AS THE EXACT DATE OF DEATH IS UNKNOWN, THE BEST ESTIMATE WAS USED, WHICH IS THE AWARENESS DATE TO THIS ADDITIONAL INFORMATION.

  Patient problems: Death; Rupture

  MAUDE report 10803717 ↗
• InjuryOct 12, 2020Material Puncture/Hole; Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Material Puncture/Hole; Improper or Incorrect Procedure or Method; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 48 DAYS POST INITIAL IMPLANT, DURING A ROUTINE FOLLOW UP, A TYPE 3B ENDOLEAK WAS IDENTIFIED BY A COMPUTED TOMOGRAPHY (CT). THE PATIENT WAS ASYMPTOMATIC. THE PHYSICIAN COMPLETED A SUCCESSFUL RE-INTERVENTION BY RELINED THE EXISTING GRAFT WITH ANOTHER AFX2 BIFURCATED STENT GRAFT. THE TYPE 3B ENDOLEAK WAS RESOLVED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY AND REPORTEDLY IS DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 10667519 ↗
• InjurySep 30, 2019Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A LEFT-SIDE GRAFT LIMB OCCLUSION. HOWEVER, THE EXACT DATE OF EVENT IS UNKNOWN. THE PHYSICIAN PLANS TO RE-INTERVENE BUT SURGERY HAS NOT BEEN SCHEDULED. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Occlusion

  MAUDE report 9136415 ↗
• InjuryFeb 19, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 BIFURCATED STENT GRAFT AND OVATION IX ILIAC LIMB. APPROXIMATELY EIGHT (8) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A PROXIMAL LEAK IN THE BIFURCATED DEVICE (TYPE IA ENDOLEAK). THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN INFRARENAL AFX DEVICE ON (B)(6) 2019. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8351580 ↗
• InjuryApr 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, VELA SUPRARENAL, AND TWO (2) VELA INFRARENALS ON (B)(6) 2017. AFTER THE INDEX PROCEDURE WAS COMPLETED THE SAME DAY, THE PATIENT'S BLOOD PRESSURE DROPPED AND THE IMPLANTING PHYSICIAN CONCLUDED THAT THE PATIENT HAD A RUPTURE IN THE ILIAC. THIS PHYSICIAN THEN RE-ACCESSED THE PATIENT'S GROIN AND IMPLANTED TWO (2) OVATION LIMB STENT GRAFTS AND THREE (3) EXTENDERS TO STOP THE BLEEDING.

  Patient problems: Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 7445918 ↗
• InjuryFeb 27, 2018Partial Blockage; Partial Blockage

  ON (B)(4) 2018, ENDOLOGIX WAS MADE AWARE BY A REP ON A RECENT VISIT TO A PHYSICIAN AT (B)(6). BASED ON CTAS, THE PATIENT'S TWO (2) PHYSICIANS DECIDED THAT A SECONDARY PROCEDURE WAS NEEDED TO CORRECT THE MIDDLE NARROWING OF THE BIFURCATED GRAFT, WHICH WAS PLACED ON (B)(6) 2017. THE SECONDARY PROCEDURE (IVUS) WAS PERFORMED ON (B)(6) 2018 WITH A NON-ENDOLOGIX STENT. THE PROCEDURE WAS SUCCESSFUL WITH THE EXPANSION OF THE DEVICE IN THE NARROWED SEGMENT. THE PATIENT'S CONDITION WAS STABLE POST-OP SURGERY.

  Patient problems: Failure of Implant; Occlusion; Stenosis

  MAUDE report 7299124 ↗
• DeathJan 26, 2017Partial Blockage; Occlusion Within Device; Adverse Event Without Identified Device or Use Problem; Partial Blockage; Occlusion Within Device; Adverse Event Without Identified Device or Use Problem

  AFTER THE COMPLETION OF THE INITIAL IMPLANT OF A BIFURCATED STENT AND SUPRARENAL AORTIC EXTENSION ON (B)(6 2016 THE PATIENT HAD AN ADDITIONAL FEM-FEM BYPASS PROCEDURE COMPLETED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND FINAL ANGIOGRAM RUN CONFIRMED PATIENT HAD GOOD RENAL FLOW. THE PATIENT EXPIRED LATER THE SAME DAY AND THE PHYSICIAN INDICATED THE PATIENT HAD MESENTERIC ISCHEMIA INCLUDING RENAL FAILURE.

  Patient problems: Aneurysm; Death; Ischemia; Renal Failure; Shock

  MAUDE report 6281372 ↗
• InjuryOct 7, 2016Compatibility Problem; Compatibility Problem

  PATIENT INITIALLY IMPLANTED WITH NON-ENDOLOGIX BI-LATERAL STENTS AT THE AORTIC BIFURCATION. ON (B)(6) 2016 PATIENT WAS IMPLANTED WITH A BIFURCATED STENT. PATIENT PRESENTED TO EMERGENCY ROOM WITH ABDOMINAL PAIN AND THE PATIENT WAS DIAGNOSED WITH A GRAFT INFECTION. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICE AND COMPLETE AN OPEN REPAIR. THE PATIENT IS STABLE.

  Patient problems: Abdominal Pain; Failure of Implant; Unspecified Infection

  MAUDE report 6012862 ↗
• InjuryAug 12, 2016Partial Blockage; Partial Blockage

  IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2016 WITH A BIFURCATED AND 3 OVATION EXTENDERS. DURING THE PROCEDURE, WIRE ACCESS WAS LOST AND PUSHED BACK UP AFTER BIFURCATED DEVICE PLACEMENT, INADVERTENTLY PLACING THE WIRE BEHIND THE GRAFT. THE PHYSICIAN PROCEEDED TO PLACE A LIMB EXTENSION BEHIND THE BIFURCATED LIMB, EFFECTIVELY SHUTTING OFF FLOW TO THE RIGHT COMMON AND EXTERNAL ILIAC. THEY WERE UNABLE TO CORRECT THE ISSUE SO DUE TO THE OCCLUDED ILIAC, THE PHYSICIAN HAD TO CONVERT TO A FEM-FEM BYPASS. PATIENT IS IN STABLE CONDITION.

  Patient problems: Occlusion

  MAUDE report 5873726 ↗

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-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-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-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-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-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-0589-06 · 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
• 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.