AFX2 Bifurcated Endograft System BEA22-90/I20-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00818009015099), received between May 8, 2018 and Aug 13, 2024 — classified as 1 death, 11 injuries.

The most frequently reported specific device problem is “Material Puncture/Hole” (6 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.

• InjuryAug 13, 2024Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024. THE AFX2 BIFURCATED STENT GRAFT DELIVERY SYSTEM WAS ADVANCED FROM THE LEFT SUPERFICIAL FEMORAL ARTERY DUE TO HIGH CALCIFICATION AROUND THE LEFT GROIN. A GORE EXCLUDER ILIAC EXTENSION WAS IMPLANTED IN THE LEFT LEG AFTER OCCLUDING THE LEFT INTERNAL ILIAC ARTERY WITH COILS. 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. THE AFX2 BIFURCATED STENT GRAFT AND AFX VELA SUPRARENAL WERE IMPLANTED FROM THE LEFT ACCESS. ANGIOGRAPHY BEFORE BALLOON TOUCH UP SHOWED ENDOLEAK AROUND THE TERMINAL AORTA. A TYPE IB ENDOLEAK FROM THE RIGHT LIMB AND A TYPE IIIA ENDOLEAK FROM THE LEFT LIMB WERE SUSPECTED SO BALLOON TOUCH-UP WAS PERFORMED ON BOTH LIMBS AND JUNCTION AT THE LEFT. THE MAJOR ENDOLEAK WAS RESOLVED, BUT A SLIGHT ENDOLEAK WAS STILL OBSERVED AROUND THE TERMINAL AORTA. THE PHYSICIAN SUSPECTED A TYPE IIIB ENDOLEAK BASED ON TIMING AND LOCATION OF ENDOLEAK AND ALSO SUSPECTS THAT IT MAY BE DUE TO THE SUTURE HOLES AS THE LEAK VOLUME IS VERY LITTLE. THE PATIENT W

  Patient problems: Clinical Endoleak

  MAUDE report 19973556 ↗
• InjuryJun 6, 2024Off-Label Use; Obstruction of Flow; Deformation Due to Compressive Stress; Off-Label Use; Obstruction of Flow; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY TREATED FOR A LEFT INTERNAL ILIAC ARTERY ANEURYSM (IIAA) ON (B)(6) 2022 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL STENT GRAFT. AT THAT TIME CIRCUMFERENTIAL CALCIFICATION STENOSIS WAS OBSERVED AROUND THE TERMINAL AORTA. A GORE (NON-ENDOLOGIX) EXCLUDER LEG WAS IMPLANTED IN THE LEFT EXTERNAL ILLIAC ARTERY (EIA). THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN AND A CT WAS TAKEN ON AN UNKNOWN DATE IN WHICH THROMBOEMBOLIZATION OF THE LEFT LIMB (AFX2 LIMB TO THE GORE LEG) WAS IDENTIFIED. BLOOD FLOW TO THE LOWER LIMB APPEARED TO BE OBTAINED FROM COLLATERAL CIRCULATION, SO THE PATIENT IS CURRENTLY EXPERIENCING INTERMITTENT CLAUDICATION. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Embolism/Embolus; Pain; Stenosis; Thrombosis/Thrombus

  MAUDE report 19480734 ↗
• InjuryMay 8, 2024Off-Label Use; Material Puncture/Hole; Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Off-Label Use; Material Puncture/Hole; Improper or Incorrect Procedure or Method; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL AORTIC EXTENSION ALONG WITH A BARE STENT (NON-ENDOLOGIX) THAT WAS ALSO IMPLANTED IN THE EXTERNAL ILIAC ARTERY (EIA) STENOSED AREA. THIS INITIAL 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 FIVE (5) YEARS POST INITIAL PROCEDURE THE PATIENT WAS TAKEN TO THE HOSPITAL BY AN AMBULANCE DUE TO AAA RUPTURE. THE CAUSE OF THE RUPTURED ANEURYSM WAS A TYPE 3B ENDOLEAK AT THE BIFURCATION OF THE AFX2 STENT GRAFT. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH AN AFX2 BIFURCATED STENT GRAFT. AN AFX2 DELIVERY SYSTEM WAS INSERTED THROUGH A DRYSEAL (NON-ENDOLOGIX) 18FR INTRODUCER SHEATH AND RESISTANCE WAS FELT WHEN ADVANCING THE INNER-CORE AND UNABLE TO DELIVER TO THE AORTA DUE TO CALCIFICATION BILATERALLY IN THE ILIAC ARTERY LIMBS. THE PHYSICIAN REMOVED THE AFX2 FROM THE PATIENT'S BODY. IT WAS FOUND THAT THE TIP OF AFX2 STENT GRAFT WAS SLIGHTLY COMING OUT FROM THE DELIVERY SYSTEM SHEATH, AND THE RED COVER WAS SLIGHTLY TORN. THE DRYSEAL INTRODUCER SH

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 19269690 ↗
• InjuryFeb 1, 2023Lack of Effect; Lack of Effect

  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 FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT WAS SEEN FOR FOLLOW UP REGARDING HIS COLON CANCER. UPON COMPUTED TOMOGRAPHY (CT) OF THE ABDOMEN, AN INDETERMINATE ENDOLEAK WAS IDENTIFIED. THE AAA IS NOT GROWING; HOWEVER, REINTERVENTION IS TO BE PERFORMED IN THE NEAR FUTURE. PATIENT STATUS WAS NOT REPORTED. NOTE: DATE OF EVENT HAS BEEN ESTIMATED BASED ON THE PROVIDED INFORMATION. AFTER THE INITIAL REPORT, ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF AN AFX VELA INFRARENAL. REINTERVENTION WAS SUCCESSFUL AND THE PATIENT IS WELL. ADDITIONALLY, THE CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST ANEURYSM ENLARGEMENT OF 15MM OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE ANEURYSM ENLARGEMENT WAS DISCOVERED DURING REVIEW OF THE 4 AND 51 MONTH POST IMPLANT CT SCANS.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16279581 ↗
• DeathFeb 14, 2022Off-Label Use; Material Puncture/Hole; Deformation Due to Compressive Stress; Separation Problem; Off-Label Use; Material Puncture/Hole; Deformation Due to Compressive Stress; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL PROXIMAL EXTENSION. APPROXIMATELY THREE AND A HALF (3.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IIIA ENDOLEAK AND COMPLETE COMPONENT SEPARATION. THE PATIENT'S CURRENT CONDITION IS UNKNOWN, AND IT IS UNKNOWN IF THE PHYSICIAN PLANS TO RE-INTERVENE. AS THE EXACT DATE OF EVENT IS UNKNOWN, THE BEST ESTIMATE WAS USED, WHICH IS THE AWARENESS DATE TO THIS EVENT.

  Patient problems: Aneurysm; Failure of Implant; Ruptured Aneurysm

  MAUDE report 13529457 ↗
• InjuryDec 16, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT, TWO (2) ENDURANT CUFFS (NON-ENDOLOGIX DEVICE), AND ONE (1) EXCLUDER CUFF (NON-ENDOLOGIX DEVICE). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, AN ANGIOGRAPHY IDENTIFIED A TYPE 3B ENDOLEAK. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT. IT WAS REPORTED THAT THE 3B ENDOLEAK WAS RESOLVED AFTER THE SECONDARY PROCEDURE. THE FINAL PATIENT STATUS REMAINS UNKNOWN. THE FINAL PATIENT STATUS WAS NOT MADE AVAILABLE TO ENDOLOGIX.

  Patient problems: Failure of Implant

  MAUDE report 13019091 ↗
• InjuryAug 6, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND TWO (2) MEDTRONIC (NON-ENDOLOGIX) ENDURANT CUFFS 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 THE AFX2 SYSTEM PER DEVICE IFU. IT WAS REPORTED THAT WHEN THE FINAL ANGIOGRAPHY WAS PERFORMED, AN INTRAOPERATIVE TYPE 1B ENDOLEAK WAS IDENTIFIED. THE SURGEON ELECTED TO IMPLANT A GORE (NON-ENDOLOGIX) EXCLUDER LEG, AND ANOTHER ANGIOGRAPHY WAS DONE WHICH SHOWED A POSSIBLE TYPE 3B ENDOLEAK. THE SURGEON THEN ELECTED TO IMPLANT ANOTHER AFX2 BIFURCATED STENT GRAFT AND AFTER A BALLOON TOUCH-UP, THE ANGIOGRAPHY SHOWED RESOLUTION OF THE ENDOLEAKS. THE PROCEDURE WAS COMPLETED.

  Patient problems: Failure of Implant

  MAUDE report 12288887 ↗
• InjuryJan 6, 2020Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY BEING TREATED FOR ABDOMINAL AORTIC ANEURYSM (AAA) WITH AFX2 ABDOMINAL AORTIC ANEURYSM STENT. REPORTEDLY, AT THE END OF THE PROCEDURE AN ANGIOGRAM WAS PERFORMED AND A INTRAOPERATIVE IIIB ENDOLEAK WAS IDENTIFIED. PHYSICIAN THEN ELECTED TO IMPLANT ANOTHER AFX2 BIFURCATED STENT GRAFT AND A PROXIMAL EXTENSION AND AT THE END OF THE PROCEDURE ANGIOGRAM IDENTIFIED A POSSIBLE TYPE 1B ENDOLEAK. PHYSICIAN PERFORMED A BALLOON TOUCH UP AND THE ENDOLEAK WAS STILL PRESENT. PHYSICIAN THEN ELECTED TO USE A GORE EXCLUDER (NON-ENDOLOGIX). ANGIOGRAM STILL IDENTIFIED A PERSISTENT LEAK AND PHYSICIAN SUSPECTED A TYPE IIIB ENDOLEAK, INSTEAD OF A TYPE 1B. PHYSICIAN THEN ELECTED TO IMPLANT ANOTHER PROXIMAL EXTENSION AND ANOTHER BIFURCATED STENT GRAFT. FINAL ANGIOGRAM STILL SHOWED A SLIGHT TYPE II ENDOLEAK, BUT THE PHYSICIAN ELECTED TO END THE PROCEDURE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 9555584 ↗
• InjurySep 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 2.5 YEARS POST INITIAL PROCEDURE (EXACT DATE WAS NOT PROVIDED), AN INDETERMINATE ENDOLEAK (POSSIBLE 3B AND 2) WITH SAC GROWTH WAS REPORTED. AN INTERVENTION HAS BEEN SCHEDULED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. ADDITIONAL INFORMATION: SECONDARY PROCEDURE WAS COMPLETED. THE PHYSICIAN ELECTED TO RE-LINE THE EXISTING GRAFTS WITH AND AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL STENT GRAFT EXTENSION. NO ENDOLEAK WAS IDENTIFIED. PATIENT WAS DISCHARGED HOME NINE (9) DAYS POST PROCEDURE, REPORTEDLY STABLE.

  Patient problems: Aneurysm

  MAUDE report 9077823 ↗
• InjuryNov 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS INITIALLY TREATED WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT; IT WAS NOTED THAT THE CASE WAS SEMI-EMERGENT, BUT THE INITIAL PROCEDURE WAS COMPLETED WITHOUT INCIDENT. APPROXIMATELY EIGHT (8) MONTHS POST INITIAL PROCEDURE IN LATE SEPTEMBER, THE PATIENT COMPLAINED OF NUMBNESS IN THE INFERIOR LIMB. A CT REVEALED THAT THROMBOSIS HAD CLOGGED THE ENTIRE TA. THE WIDTH OF THE TA WAS 11 MM AND ITS INTERNAL DIAMETER WAS MUCH NARROWER, BEING HEAVILY CALCIFIED AROUND THE TA. FEMORAL-FEMORAL BYPASS WAS PERFORMED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL SAFELY. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Claudication; Occlusion; Thrombosis

  MAUDE report 8091598 ↗
• InjuryNov 1, 2018Leak/Splash; Leak/Splash

  THE PATIENT WAS PREVIOUSLY IMPLANTED WITH A BIFURCATED STENT GRAFTS AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). AT TIME OF IMPLANT AN 1B ENDOLEAK WAS OBSERVED. BALLOONING WAS PERFORMED AND THE ENDOLEAK DECREASED IN SIZE. THE PHYSICIAN DECIDED TO MONITOR THE PATIENT. TEN (10) DAYS LATER, A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PREFORMED AND THE 1B ENDOLEAK WAS STILL PRESENT. AN INTERVENTION WAS PERFORMED THE FOLLOWING DAY. THE PHYSICIAN DECIDED TO IMPLANT A LIMB STENT EXTENSION AND COIL EMBOLIZATION WITH BALLOONING WAS PERFORMED. AN INTRAOPERATIVE 3A ENDOLEAK WAS SLIGHTLY OBSERVED BUT THE LEAK DID NOT FLOW INTO THE ANEURYSM SO THE PHYSICIAN DECIDED TO FINISH THE PROCEDURE AND CONTINUE TO MONITOR THE PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 8030603 ↗
• InjuryMay 8, 2018Leak/Splash; Leak/Splash

  ON (B)(6) 2016, THE PATIENT WAS IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL EXTENSION/ CUFF TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DURING THIS PROCEDURE AN INTRAOPERATIVE TYPE 1B ENDOLEAK WAS SUSPECTED. BALLOONING WAS PERFORMED HOWEVER THE ENDOLEAK WAS STILL PRESENT. AN ANGIOGRAPHY WAS PERFORMED AND A TYPE 3B ENDOLEAK WAS SUSPECTED. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER BIFURCATED STENT GRAFT. TYPE 3B ENDOLEAK WAS RESOLVED BUT A TYPE 2 ENDOLEAK WAS OBSERVED. MORE BALLOONING WAS PERFORMED AND THE TYPE 2 ENDOLEAK WAS RESOLVED.

  Patient problems: Failure of Implant

  MAUDE report 7497184 ↗

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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-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-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-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-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-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
• 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-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
• Z-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL

…and 1 more.