AFX Endovascular AAA System BA25-70/I16-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00818009010100), received between Apr 14, 2016 and Feb 20, 2024 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2024Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2014, WITH THE IMPLANTATION OF AN AFX BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL, AND AN AFX VELA SUPRARENAL. ON (B)(6) 2024, THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER SUFFERING A FALL. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED, WHICH SHOWED AN ENDOLEAK TYPE IIIB AND A 1 CM SAC ENLARGEMENT. THE PATIENT IS CURRENTLY BEING MONITORED.

  Patient problems: Clinical Endoleak

  MAUDE report 18739996 ↗
• InjuryFeb 17, 2023Unintended Movement; Unintended Movement

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX INFRARENAL AORTIC EXTENSION. APPROXIMATELY SIX AND A HALF (6.5) YEARS POST INITIAL PROCEDURE, THE PATIENT WENT TO THE HOSPITAL FOR AN UNKNOWN REASON. A COMPUTERIZED TOMOGRAPHY WAS PERFORMED IDENTIFYING THAT THE OVERLAP OF THE TWO STENTS WAS ALMOST SEPARATED. REINTERVENTION WAS PERFORMED ON (B)(6) 2023. REINTERVENTION DETAILS WERE NOT PROVIDED. PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 16400214 ↗
• InjuryMar 9, 2022Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL AORTIC EXTENSION. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, A JUNCTION SEPARATION BETWEEN THE AFX BIFURCATED STENT GRAFT AND THE AFX VELA SUPRARENAL AORTIC EXTENSION WITH A TYPE IIIA ENDOLEAK AND ANEURYSM ENLARGEMENT OF OVER 15MM WAS CONFIRMED BY CT AT ROUTINE FOLLOW-UP. REINTERVENTION IS PENDING. REPORTEDLY, THE PATIENT IS ASYMPTOMATIC.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 13716686 ↗
• InjuryFeb 22, 2022Migration; Migration

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL EXTENSION. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE AT ROUTINE FOLLOW-UP IT WAS CONFIRMED THAT THE JUNCTION BETWEEN THE STENT GRAFTS HAD BEEN REDUCED TO 1CM OR LESS. ADDITIONALLY, THE DISTANCE BETWEEN THE LOWER RENAL ARTERY AND THE BIFURCATED STENT GRAFT HAD INCREASED BY 1CM OR MORE. ALTHOUGH THERE WAS NO EVIDENT ENDOLEAK ON CT IMAGING, IT WAS DECIDED TO PERFORM REINTERVENTION CONSIDERING THE POSSIBILITY OF AN INTERMITTENT TYPE IIIA ENDOLEAK. REINTERVENTION WAS PERFORMED WITH IMPLANT OF AN AFX VELA SUPRARENAL AND AN AFX VELA INFRARENAL. THE FINAL PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 13579944 ↗
• InjuryJul 6, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A SUPRARENAL AORTIC EXTENSION AND TWO (2) ILIAC LIMB EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED TYPE 1B, 2, 3B ENDOLEAKS AND THAT THE LEFT ILIAC LIMB EXTENSION HAD MIGRATED PROXIMALLY. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED. ADDITIONAL INFORMATION: CLINICAL EVALUATION SHOWS THAT A RE-INTERVENTION WAS COMPLETED. THE PATIENT WAS IMPLANTED WITH BILATERAL LIMBS STENT AND AN EXTENDER (NON-ENDOLGOIX STENTS). THE PATIENT STATUS WAS REPORTED BEING STABLE POST THE SECONDARY ENDOVASCULAR PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 12124938 ↗
• InjuryOct 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A VELA SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS LATER DURING A ROUTINE FOLLOW UP, A TYPE 3A ENDOLEAK WAS IDENTIFIED. A REINTERVENTION IS PLANNED AND THE PATIENT IS REPORTEDLY STABLE. SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION WAS PROVIDED REPORTING THAT SUCCESSFUL RE-INTERVENTION WAS COMPLETED WITH IMPLANT OF AN ADDITIONAL AFX VELA INFRARENAL BRIDGING THE PREVIOUSLY IMPLANTED DEVICES AND SEALING THE TYPE IIA ENDOLEAK. THE FINAL PATIENT STATUS WAS REPORTED TO BE DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 10667317 ↗
• InjuryMay 1, 2020Insufficient Device Problem Information; Separation Problem; Insufficient Device Problem Information; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, A COMPUTED TOMOGRAPHY ANGIOGRAM REVEALED THE PATIENT HAD A 3A ENDOLEAK WITH COMPONENT SEPARATION. A RE-INTERVENTION WAS ATTEMPTED BUT WAS UNSUCCESSFUL. A FEW DAYS LATER, THE PHYSICIAN THEN ELECTED TO PERFORM AN OPEN REPAIR AND EXPLANT THE DEVICE. REPORTEDLY THE EXPLANT WENT WELL AND THE PATIENT IS STABLE.

  Patient problems: Failure of Implant

  MAUDE report 10018184 ↗
• InjurySep 30, 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 4.5 YEARS POST INITIAL PROCEDURE, SAC GROWTH WITH AN ENDOLEAK OF INDETERMINATE ORIGIN WAS REPORTED. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA INFRARENAL STENT GRAFT TO TREAT THIS EVENT. THE PATIENT'S STATUS WAS NOT PROVIDED BUT THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm

  MAUDE report 9136958 ↗
• InjuryJun 11, 2019Material Puncture/Hole; Insufficient Device Problem Information; Material Puncture/Hole; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY THREE (3) YEARS POST INITIAL IMPLANT DURING A ROUTINE FOLLOW-UP CTA SCAN THE PATIENT WAS FOUND TO ANEURYSM SAC ENLARGEMENT OF ONE (1) CENTIMETER. THERE IS NO EVIDENCE OF AN ACTIVE LEAK OCCURRING AND A FOLLOW-UP CT SCAN WILL BE PERFORMED AT A LATER DATE. THE PATIENT IS STATED AS BEING IN GOOD CONDITION. NO FURTHER ADDITIONAL INFORMATION OR PATIENT SEQUELAE HAS BEEN REPORTED AT THIS TIME. ADDITIONALLY, CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST A TYPE IIIB ENDOLEAK OF THE CUFF OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8687338 ↗
• InjuryApr 19, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  THE PATIENT WAS IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND VELA SUPRARENAL ON (B)(6) 2016. ON A LATER DATE, THE PHYSICIAN OBSERVED A TYPE 3A ENDOLEAK AND ENLARGED SAC. THE SUBSEQUENT SECONDARY PROCEDURE WAS COMPLETED ON (B)(6) 2017 AND THE PATIENT WAS IMPLANTED WITH AN AFX VELA SUPRARENAL. THERE WERE NO REPORTS OF THE PATIENT BEING SYMPTOMATIC AND THE DEVICES WERE NOT EXPLANTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7445909 ↗
• InjuryNov 8, 2017Failure To Adhere Or Bond; Detachment Of Device Component; Leak/Splash; Failure To Adhere Or Bond; Detachment Of Device Component; Leak/Splash

  ON (B)(6) 2015, THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND FOUR (4) LIMB EXTENSION. ON (B)(6) 2017, ENDOLOGIX WAS MADE AWARE OF A TYPE 3A ENDOLEAK WITH SAC GROWTH. ON (B)(6) 2017, THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANT WITH OVATION DEVICES TO SEAL THE ENDOLEAK. PATIENT REPORTED AS DOING WELL. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7011706 ↗
• InjuryOct 3, 2017Difficult or Delayed Positioning; Material Fragmentation; Use of Device Problem; Device Or Device Fragments Location Unknown; Patient-Device Incompatibility; Difficult or Delayed Positioning; Material Fragmentation; Use of Device Problem; Device Or Device Fragments Location Unknown; Patient-Device Incompatibility

  PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION ON (B)(6) 2017. ON (B)(6) 2017, THE DOCTOR NOTICED A FOREIGN MATERIAL BEING LEFT INSIDE THE PATIENT'S BODY AROUND LEFT ILIAC ARTERY. IT APPEARS TO LOOK LIKE A COVER OF THE CONTRALATERAL LIMB STENT GRAFT AND THE POSSIBILITY OF THE COVER BEING LEFT INSIDE THE BODY CANNOT BE EXCLUDED BUT HAS NOT BEEN CONFIRMED. THE PATIENT CONDITION IS STABLE AND ASYMPTOMATIC AT THIS POINT. SINCE PARAPLEGIA WAS NOT CONFIRMED AT THE END OF OPERATION, DOCTORS HAVE DECIDED TO KEEP MONITORING THIS PATIENT WITHOUT FURTHER OPERATION AT THIS POINT. AS OF DATE, NO ADDITIONAL PATIENT SEQUELAE HAS BEEN REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6912236 ↗
• MalfunctionMay 6, 2016Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  THE PHYSICIAN WAS ABLE TO SEAL THE ENDOLEAK BY IMPLANTING A NON-ENDOLOGIX STENT ON (B)(6) 2016.

  Patient problems: Failure of Implant; Intimal Dissection

  MAUDE report 5637423 ↗
• InjuryApr 30, 2016Difficult or Delayed Positioning; Difficult To Position; Device Operates Differently Than Expected; Difficult or Delayed Positioning; Difficult To Position; Device Operates Differently Than Expected

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION ON (B)(6) 2016. DURING INITIAL PROCEDURE THE PHYSICIAN DID NOT PLACE THE SUPRARENAL AORTIC EXTENSION IN THE CORRECT LOCATION. THE INCORRECT PLACEMENT RESULTED IN REDUCED BLOOD FLOW THROUGH THE LEFT ILIAC ARTERY. THE PHYSICIAN CORRECTED THE ISSUE BY COMPLETING A FEM-FEM BYPASS. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Occlusion

  MAUDE report 5622831 ↗
• InjuryApr 14, 2016Hole In Material; Hole In Material

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION ON (B)(6) 2016. UPON FOLLOW UP AN ANGIOGRAM REVEALED A TYPE 3B ENDOLEAK. THE PHYSICIAN ELECTED TO RELINE THE MAIN BODY WITH ANOTHER BIFURCATED STENT TO RESOLVE THE ISSUE. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 5580059 ↗

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-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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-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-0593-06 · 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-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• 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-0592-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL

…and 1 more.