AFX Endovascular AAA System BA28-70/I16-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00818009010117), received between Jun 17, 2016 and Jun 1, 2023 — classified as 1 death, 14 injuries.

The most frequently reported specific device problem is “Leak/Splash” (7 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.

• DeathJun 1, 2023Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT INITIALLY RECEIVED TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) THROUGH THE IMPLANTATION OF AN AFX BIFURCATED STENT GRAFT, TWO (2) AFX LIMB STENT GRAFTS AND AN AFX VELA SUPRARENAL. APPROXIMATELY SEVEN (7) YEARS FROM THE INITIAL PROCEDURE, THE PATIENT WAS URGENTLY ADMITTED DUE TO AN AORTIC RUPTURE. IMAGING REVEALED THE PRESENCE OF AN ENDOLEAK TYPE IIIB, ENDOLEAK TYPE IA, AND A LIMB OCCLUSION. THE PATIENT EXPERIENCED A CARDIAC ARREST AND ULTIMATELY PASSED AWAY.

  Patient problems: Cardiac Arrest; Clinical Endoleak; Obstruction/Occlusion; Rupture

  MAUDE report 17044302 ↗
• InjuryApr 1, 2022Off-Label Use; Appropriate Device Problem Term/Code Not Available; Migration; Off-Label Use; Appropriate Device Problem Term/Code Not Available; Migration

  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. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE AT ROUTINE FOLLOW-UP, THE COMPUTERIZED TOMOGRAPHY SCAN IDENTIFIED A TYPE IIIA ENDOLEAK OF THE BIFURCATED STENT GRAFT AND A TYPE IA OF THE VELA SUPRARENAL. REINTERVENTION HAS NOT YET BEEN PLANNED. THE PATIENT IS DOING WELL.

  Patient problems: Aneurysm; Failure of Implant; Renal Failure; Unspecified Infection

  MAUDE report 13978304 ↗
• InjuryOct 1, 2021Material Puncture/Hole; Patient-Device Incompatibility; Device-Device Incompatibility; Material Integrity Problem; Separation Problem; Material Puncture/Hole; Patient-Device Incompatibility; Device-Device Incompatibility; Material Integrity Problem; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX BIFURCATED STENT GRAFT AND VELA SUPRARENAL PROXIMAL EXTENSION. APPROXIMATELY SIX (6) YEARS PATIENT PRESENTED WITH AN ENDOLEAK TYPE 3B AND A SIGNIFICANT ANEURYSM ENLARGEMENT (OF 7CM). THE PATIENT IS CURRENTLY BEING MONITORED AND IS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12565527 ↗
• InjuryMar 2, 2020Misconnection; Separation Problem; Misconnection; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED ASYMPTOMATIC WITH AN INCIDENTAL FINDING OF A TYPE IIIA ENDOLEAK AND COMPONENT SEPARATION BETWEEN THE BIFURCATED DEVICE AND LIMB STENT GRAFT. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN ADDITIONAL AFX LIMB DEVICE ON (B)(6) 2020. THE PATIENT WAS REPORTEDLY IN STABLE CONDITION. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Ischemia; Respiratory Failure

  MAUDE report 9777417 ↗
• InjuryDec 13, 2019Misconnection; Use of Device Problem; Improper or Incorrect Procedure or Method; Misconnection; Use of Device Problem; Improper or Incorrect Procedure or Method

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY FOUR AND A HALF (4.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IIIA ENDOLEAK AND DISCONNECT BETWEEN THE BIFURCATED AND PROXIMAL EXTENSION DEVICES. THE PHYSICIAN PLANS TO RE-INTERVENE AND SURGERY HAS NOT BEEN SCHEDULED. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. THE PATIENT PREVIOUSLY WAS TREATED FOR AN AORTIC RUPTURE AND TYPE IIIB ENDOLEAK WITH A NON-ENDOLOGIX DEVICE ON (B)(6) 2019; REFERENCE MFR. REPORT # 2031527-2019-00155 FOR REPORT. THEREFORE, THIS EVENT WHICH OCCURRED ON (B)(6) 2019 IS RELATED TO THE OFF-LABEL RE-INTERVENTION IN (B)(6) 2019.

  Patient problems: Failure of Implant

  MAUDE report 9469644 ↗
• InjuryAug 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION AND AN INFRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, SAC GROWTH WITH NO OBVIOUS LEAK WAS REPORTED. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION: A CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST A RUPTURE.

  Patient problems: Aneurysm; Rupture

  MAUDE report 8907094 ↗
• InjuryApr 2, 2019Off-Label Use; Material Puncture/Hole; Product Quality Problem; Improper or Incorrect Procedure or Method; Material Integrity Problem; Off-Label Use; Material Puncture/Hole; Product Quality Problem; Improper or Incorrect Procedure or Method; Material Integrity Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT, A VELA SUPRARENAL STENT GRAFT EXTENSION, AND A VELA INFARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY FOUR (4) YEARS POST INITIAL IMPLANT THE PATIENT PRESENTED WITH A RUPTURE AND POSSIBLE IIIB ENDOLEAK. THE PHYSICIAN PERFORMED A SECONDARY PROCEDURE WHERE THE PATIENT WAS RELINED WITH A NON-ENDOLOGIX DEVICE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL POST-SECONDARY PROCEDURE AND IS REPORTED AS DOING EXCELLENT. NO FURTHER ADDITIONAL INFORMATION OR PATIENT SEQUALAE HAS BEEN REPORTED AT THIS TIME.

  Patient problems: Failure of Implant; Rupture

  MAUDE report 8476204 ↗
• InjuryDec 1, 2018Loss of or Failure to Bond; Leak/Splash; Appropriate Device Problem Term/Code Not Available; Loss of or Failure to Bond; Leak/Splash; Appropriate Device Problem Term/Code Not Available

  AN AFX BIFURCATED AND SUPRARENAL EXTENSIONS (2) WERE INITIALLY IMPLANTED. I WAS INFORMED YESTERDAY OF AN EXPLANT OF AN AFX GRAFT. THE PATIENT RETURNED THREE (3) YEARS POST-OP SHOWING EVIDENCE OF A TYPE IA ENDOLEAK AND ANEURYSM ENLARGEMENT; THE SAC WAS REPORTED TO HAVE GROWN 2CM SINCE INITIAL IMPLANT. IT WAS NOTED THAT THE PATIENT HAD NOT RETURNED FOR FOLLOW-UP FOR OVER THREE YEARS. THE PHYSICIAN ELECTED TO CONVERT THE PATIENT TO OPEN SURGICAL REPAIR AND EXPLANT THE STENT GRAFT. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8122683 ↗
• InjuryAug 16, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS INITIALLY TREATED WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT ON (B)(6) 2014. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN EXPANDING ANEURYSM ON (B)(6) 2018. ENDOLOGIX BECAME AWARE OF THE REPORTED ADVERSE EVENT ON (B)(6) 2018. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING WITH A GORE (NON-ENDOLOGIX) DEVICE. THE PATIENT TOLERATED THE SECONDARY PROCEDURE WELL.

  Patient problems: Aneurysm

  MAUDE report 7792240 ↗
• InjuryMay 16, 2018Leak/Splash; Leak/Splash

  ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE OF A PATIENT WITH AN ENLARGED AAA (SAC GROWTH-6.9CM) FROM A ROUTINE FOLLOW UP CT SCAN. IT WAS ALSO NOTED THAT THERE IS EVIDENT OF A TYPE 3A AND POSSIBLE TYPE 3B ENDOLEAK. THE PHYSICIAN IS PLANNING TO TREAT THE PATIENT WITH A AUI DEVICE. NO DATE FOR THE RE-INTERVENTION HAVE BEEN SET OR CONFIRMED. PATIENT IS CURRENTLY IN STABLE CONDITION AND WILL BE MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 7521051 ↗
• InjuryNov 6, 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) 2014, THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL EXTENSION. ON (B)(6) 2017, A TYPE 3A ENDOLEAK WAS DISCOVERED. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL SUPRARENAL EXTENSION TO SEAL THE ENDOLEAK. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant; Rupture

  MAUDE report 7004088 ↗
• InjuryOct 10, 2017Failure To Adhere Or Bond; Detachment Of Device Component; Leak/Splash; Failure To Adhere Or Bond; Detachment Of Device Component; Leak/Splash

  THE PHYSICIAN COMPLETED A SECONDARY PROCEDURE ON (B)(6) 2017. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION TO SEAL THE ENDOLEAK. CORRECTION, AFTER COMPLETING A LOT HISTORY REVIEW IT WAS IDENTIFIED THE IMPLANTED STENT WAS AN INTUITRAK BIFURCATED STENT AND NOT AN AFX BIFURCATED DEVICE.

  Patient problems: Failure of Implant; Heart Failure

  MAUDE report 6935871 ↗
• InjuryJul 13, 2017Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  AN AFX BIFURCATED STENT GRAFT, AND TWO SUPRARENAL CUFF EXTENSIONS WERE IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE BIFURCATED STENT GRAFT AND THE SUPRARENAL CUFF EXTENSION WERE IMPLANTED AS PLANNED, WITH THE SUPRARENAL CUFF EXTENSION POSITIONED JUST BELOW THE RENAL ARTERY. THE SECOND SURARENAL CUFF EXTENSION WAS SUCCESSFULLY IMPLANTED ABOVE THE TERMINAL AORTA TO OBTAIN SUFFICIENT OVERLAP. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A SUSPECTED TYPE IB ENDOLEAK, THAT COULD NOT BE RESOLVED FOLLOWING THE PLACEMENT OF AN ADDITIONAL EXTENSION IN EACH LEG EXTENDING DOWN TO THE EXTERNAL ILIAC ARTERY. THE PROCEDURE WAS CONCLUDED WITH NO FURTHER TREATMENT. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 6712595 ↗
• InjuryFeb 3, 2017Failure To Adhere Or Bond; Detachment Of Device Component; Leak/Splash; Device Dislodged or Dislocated; Failure To Adhere Or Bond; Detachment Of Device Component; Leak/Splash; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT HAD AN INITIAL IMPLANT ON (B)(6) 2014 WITH A BIFURCATED STENT, A SUPRARENAL AORTIC EXTENSION, AND AN INFRARENAL AORTIC EXTENSION. ON (B)(6) 2017 THE PATIENT CAME IN EMERGENTLY TO THE HOSPITAL AND THE PHYSICIAN IDENTIFIED A TYPE 3A ENDOLEAK WITH COMPONENT SEPARATION. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICES. THE SUBSEQUENT ENDOVASCULAR PROCEDURE WAS COMPLETED AND THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

  Patient problems: Failure of Implant; Ischemia; Necrosis; Renal Failure; Rupture; Stroke/CVA; Thrombosis

  MAUDE report 6299205 ↗
• InjuryJun 17, 2016Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2016 WITH A BIFURCATED DEVICE. AFTER THE CASE, THE ANGIOGRAM LOOKED GREAT WITH NO LEAKS. THE PATIENT HAD COMPLICATIONS POST PROCEDURE AND HAD TO BE REVIVED. THE PATIENT WAS RETURNED TO STABLE CONDITION. A FOLLOW-UP COMPUTED TOMOGRAPHY DONE ON (B)(6) 2016 REVEALED A TYPE 1A ENDOLEAK. AN ATTEMPT WAS MADE TO TRY TO REPAIR THE LEAK USING A NON-ENDOLOGIX STENT . THAT WAS NOT SUCCESSFUL, SO TWO DIFFERENT NON-ENDOLOGIX STENTS WERE USED, ALONG WITH A RENAL SNORKEL, TO RESOLVE THE ISSUE.

  Patient problems: Failure of Implant

  MAUDE report 5733885 ↗

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-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-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-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-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-0593-06 · 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
• 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.