AFX2 Bifurcated Endograft System BEA28-70/I20-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00818009014566), received between Jan 5, 2018 and Mar 30, 2026 — classified as 1 death, 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL, A VELA INFRARENAL, AN AFX ILIAC LIMB, AND AN OVATION IX ILIAC LIMB TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2026. THREE (3) DAYS POST INITIAL PROCEDURE, THE PATIENT WAS SCHEDULED FOR AN ADDITIONAL PROCEDURE FOR AN UNKNOWN REASON; HOWEVER, THE PROCEDURE WAS CANCELLED AS THE PATIENT CHANGED THEIR MIND ABOUT HAVING THIS PROCEDURE AND WAS MOVED TO COMFORT CARE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE. NOTE: THE AFX2 SYSTEM WAS EVALUATED USING ENDOLOGIX COMPONENTS. THE SAFETY AND EFFECTIVENESS OF OTHER STENT GRAFT DEVICES USED IN CONJUNCTION WITH THE AFX2 SYSTEM HAVE NOT BEEN ESTABLISHED.

  Patient problems: Insufficient Information

  MAUDE report 24711860 ↗
• InjuryJan 8, 2024Separation Problem; Separation Problem

  THE PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT, AFX VELA SUPRARENAL, AND A GORE (NON-ENDOLOGIX) EXCLUDER. THIS INITIAL PROCEDURE FALLS OUTSIDE THE INDICATIONS FOR USE (OFF-LABEL) DUE TO THE UTILIZATION OF ADJUNCTIVE DEVICES THAT ARE NOT COMPATIBLE WITH THE AFX SYSTEM. APPROXIMATELY THREE AND A HALF (3.5) YEARS POST THE INITIAL PROCEDURE, THE PATIENT REPORTED EXPERIENCING CHEST AND STOMACH PAIN SINCE THE END OF NOVEMBER 2023. THE PATIENT LOST CONSCIOUSNESS AND WAS TRANSFERRED TO ANOTHER HOSPITAL ON (B)(6), 2023. A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED IMPLANT SEPARATION, AN ENDOLEAK TYPE IIIA AND INTRA-ABDOMINAL BLEEDING, RESULTING IN THE DIAGNOSIS OF A RUPTURE (AORTA). THE PATIENT WAS THEN TRANSFERRED TO ANOTHER HOSPITAL, WHERE AN EMERGENCY RE-INTERVENTION TOOK PLACE. DURING THIS PROCEDURE, A GORE (NON-ENDOLOGIX) CTAG WAS IMPLANTED UNDER THE RENAL ARTERY, AND TWO (2) GORE (NON-ENDOLOGIX) EXCLUDER CUFFS WERE ADDED. IT WAS REPORTED THAT THE RE-INTERVENTION EFFECTIVELY RESOLVED THE ENDOLEAK TYPE IIIA. THE FINAL PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Abdominal Pain; Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 18465790 ↗
• InjuryFeb 8, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA INFRARENAL STENT GRAFT, AND AN OVATION IX EXTENDER 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 ONE (1) YEAR POST INITIAL IMPLANT, THE PATIENT PRESENTED EMERGENTLY WITH BACK AND ABDOMINAL PAIN. A COMPUTED AXIAL TOMOGRAPHY (CAT) SCAN IDENTIFIED A RUPTURED ANEURYSM AND SUBSEQUENT ANGIOGRAM REVEALED TYPE 1B AND TYPE 3B ENDOLEAKS. THE PHYSICIAN COMPLETED A SUCCESSFUL RE-INTERVENTION WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AND A NON-ENDOLOGIX (GORE VBX) ILIAC STENT TO RESOLVE THE ENDOLEAKS. THE PATIENT REPORTEDLY IS DOING WELL POST RE-INTERVENTION.

  Patient problems: Failure of Implant; Pain; Rupture

  MAUDE report 11294594 ↗
• InjuryJan 11, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL STENT GRAFT EXTENSION, A NON-ENDOLOGIX (GORE EXCLUDER LEG) AND INTERNAL ILIAC COILING TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT THE A NON-ENDOLOGIX (GORE EXCLUDER LEG) AND INTERNAL ILIAC COILING WERE IMPLANTED PRIOR TO THE AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL STENT GRAFT EXTENSION THEREFORE 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. AN ENDOLEAK (POSSIBLE TYPE 2 OR 3A) WAS IDENTIFIED ON THE POST PROCEDURE ANGIOGRAPHY, HOWEVER SINCE THROMBUS WAS CIRCUMFERENTIALLY PRESENT AROUND THE PROXIMAL NECK, IT WAS DECIDED TO MONITOR THE PATIENT WITHOUT PERFORMING ADDITIONAL TREATMENT. NOW APPROXIMATELY TWO (2) MONTHS POST INITIAL PROCEDURE, AN ENDOLEAK WAS STILL PRESENT ALTHOUGH THE TYPE COULD NOT BE IDENTIFIED. THERE WAS NO PLAN TO PERFORM ANY RE-INTERVENTION AT THIS POINT. THE PATIENT WILL BE MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 11149122 ↗
• InjuryNov 3, 2020Device-Device Incompatibility; Insufficient Device Problem Information; Device-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL STENT GRAFT EXTENSION. DURING THE PROCEDURE A TYPE 3A ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN ELECTED TO IMPLANT A NON-ENDOLOGIX (PALMAZ) STENT, BUT THE ENDOLEAK REMAINED UNRESOLVED. THE PHYSICIAN IS MONITORING THE PATIENT AND WILL PERFORM A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN TO SEE IF THE ENDOLEAK IS STILL PRESENT. THE PATIENT IS REPORTEDLY STABLE.

  Patient problems: Failure of Implant

  MAUDE report 10779863 ↗
• InjuryJul 23, 2020Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY, ONE MONTH POST INITIAL PROCEDURE PATIENT WAS IDENTIFIED WITH A TYPE IB ENDOLEAK AND WAS TREATED WITH AN AFX LIMB EXTENSION. APPROXIMATELY, ONE YEAR AND THREE MONTHS POST-SECONDARY PROCEDURE ANEURYSM ENLARGEMENT, AN INDETERMINANT ENDOLEAK AND POSSIBLE STENT MOVEMENT OF THE AFX VELA SUPRARENAL WERE IDENTIFIED. IT WAS NOTED AN ENDOLEAK FROM THE THORACIC ARTERY OF THE AFX2 BIFURCATED STENT GRAFT. THE PATIENT WAS TREATED WITH IMPLANT OF TWO AFX VELA SUPRARENAL¿S. ANGIOGRAPHY SHOWED THE SAME ENDOLEAK FROM THE THORACIC ARTERY OF THE AFX2 BIFURCATED STENT GRAFT; THEREFORE, IT WAS DETERMINED IT WAS A TYPE IIIB ENDOLEAK. THIS WAS TREATED WITH IMPLANT OF AN ENDURANT MAIN BODY AND AN EXCLUDER LED. THE TYPE IIIB ENDOLEAK WAS SUCCESSFULLY SEALED. THE PREVIOUSLY EVENT OF TYPE IB ENDOLEAK WAS REPORTED UNDER MFR #2031527-2020-00210.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 10316964 ↗
• InjuryJul 20, 2020Insufficient Device Problem Information; Separation Problem; Insufficient Device Problem Information; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL WERE IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY, 2 (TWO) YEARS POST INITIAL PROCEDURE, A COMPUTERIZED TOMOGRAPHY IMAGE IDENTIFIED A POSSIBLE TYPE IIIA ENDOLEAK WITH DEVICE SEPARATION. ANEURYSM ENLARGEMENT WAS NOT IDENTIFIED. REPORTEDLY, THE PATIENT IS DOING WELL AND RE-INTERVENTION IS PENDING. SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT SUCCESSFUL RE-INTERVENTION WAS PERFORMED WITH IMPLANT OF AN AFX VELA INFRARENAL.

  Patient problems: Failure of Implant

  MAUDE report 10299755 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AFX2 BIFURCATED STENT GRAFT AND AN AFX SUPRARENAL AORTIC EXTENSION WERE IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). REPORTEDLY, THIS WAS A THROMBOTIC ANEURYSM CASE AND THE INNER DIAMETER OF ANEURYSM WAS NARROWER PRIOR TO EVAR. THE INDEX PROCEDURE WAS SUCCESSFULLY COMPLETED. APPROXIMATELY TWO (2) MONTHS POST OP, THE ROUTINE FOLLOW-UP CT IDENTIFIED THROMBOSIS THROUGHOUT THE MAIN BODY AND THE VELA SUPRARENAL EXTENSION. THE PATIENT IS BEING MONITORED.

  Patient problems: Thrombosis

  MAUDE report 8537467 ↗
• InjuryApr 8, 2019Off-Label Use; Off-Label Use

  ON (B)(6) 2019, EVAR WAS PERFORMED FOR THE PATIENT WITH A RIGHT IIA ANEURYSM. THE RIGHT IIA WAS OCCLUDED BY A PLUG AND COIL FIRST, AND THEN A NON- ENDOLOGIX (GORE/ EXCLUDER LEG) STENT WAS DEPLOYED ON THE RIGHT LEG. ITS FINAL POSITION WAS SLIGHTLY DISTAL THAN THE INTENDED. THEN FROM THE LEFT ACCESS, THE AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF- LABEL). BALLOON TOUCH UP WAS PERFORMED. AN ANGIOGRAM WAS PREFORMED. A TYPE 3A ENDOLEAK WAS SUSPECTED. MORE BALLOON TOUCH UP WAS PERFORMED. ANOTHER NON - ENDOLGIX (GORE/ EXCLUDER LEG ) STENT WAS ADDED IN THE RIGHT LEG. BALLOON TOUCH-UP WAS THEN PERFORMED AGAIN AND THE BALLOON RUPTURED SO IT WAS EXCHANGED TO A STIFFER CODA BALLOON. AN ENDOLEAK WAS STILL OBSERVED AND THE LUMBAR ARTERY WAS ALSO OBSERVED. A TYPE 1A ENDOLEAK WAS IDENTIFIED. TWO (2) NON - ENDOLGIX (GORE/ EXCLUDER CUFF) WERE IMPLANTED TO THE PROXIMAL END OF THE AFX2 BIFURCATED STENT GRAFT. BALLOON TOUCH UP WAS PERFORMED AGAIN. A TYPE 3A OR 3B ENDOLEAK (UNKNOWN ORIGIN) WAS SUSPECTED. TWO (2) MORE NON - ENDOLGIX (GORE/ EXCLUDER LEGS) STENTS WERE IMPLANTED ALONGSIDE IN THE AFX2 BIFURCATED STENT GRAFT. AN ENDOLEAK WAS STILL OBSERVED

  Patient problems: Failure of Implant

  MAUDE report 8494165 ↗
• InjuryFeb 7, 2019Use of Device Problem; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem

  DURING THE REPAIR OF A PREVIOUS REPORTED EVENT (2031527-2019-00070), A DEPLOYMENT ISSUE OF THE BIFURCATED STENT GRAFT WAS REPORTED. THE PATIENT WAS BEING RELINED WITH A COOK Z-FEN TOPPER AND COOK THORACIC GRAFT DOWN BIFURCATION. THESE ARE BOTH NON-ENDOLOGIX STENTS AND THIS PROCEDURE IS CONSIDERED TO BE OFF-LABEL. WHEN THE PHYSICIAN WAS IMPLANTING ANOTHER AFX2 BIFURCATED STENT GRAFT (ENDOLOGIX), THE STENT BECAME STUCK BEHIND THE NON-ENDOLOGIX STENT STRUT CAUSING THE DEPLOYMENT ISSUE. THE PHYSICIAN CONVERT INTO AUI GRAFT WITH BLOOD FLOW TO RIGHT SIDE ONLY. AFTER THAT PHYSICIAN PLUGGED THE LEFT COMMON ILIAC, HE DID A FEM TO FEM BYPASS FROM RIGHT SIDE TO LEFT SIDE TO RESTORE FLOW INTO LEFT SIDE. THE PATIENT WAS REPORTED AS DOING WELL. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8316695 ↗
• InjuryJan 18, 2019Loss of or Failure to Bond; Leak/Splash; Stretched; Material Protrusion/Extrusion; Unintended Movement; Loss of or Failure to Bond; Leak/Splash; Stretched; Material Protrusion/Extrusion; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED CONFIRMING THAT THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING WITH A BIFURCATED AFX2 AND AN INFRARENAL AFX DEVICES ON (B)(6) 2019. IN ADDITION, CLINICAL ASSESSMENT REFUTED THE REPORTED TYPE IIIA ENDOLEAK. THIS REPORT IS ONLY FOR THE BIFURCATED STENT GRAFT. REFERENCE MFR. REPORT # 2031527-2019-00039 FOR REPORT TO THE PROXIMAL EXTENSION (INFRARENAL AORTIC EXTENSION).

  Patient problems: Failure of Implant

  MAUDE report 8262241 ↗
• DeathJan 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE INITIAL IMPLANT OF AN AFX2 DEVICE ON (B)(6) 2017 THE PATIENT EXPIRED. THE IMPLANT OF THE AFX2 DEVICE WAS SUCCESSFUL AND NO ISSUES WERE REPORTED. AFTER THE PLACEMENT OF THE DEVICE, THE PATIENT WENT INTO CARDIAC ARREST, AFTER 15 MINUTES OF CPR, THE PHYSICIAN WAS UNABLE TO RETURN THE PATIENT'S HEART RATE. PATIENT DIED ON THE OPERATING TABLE.

  Patient problems: Death; Heart Failure

  MAUDE report 7168375 ↗

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

…and 1 more.