AFX Endovascular AAA System BA22-90/I16-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00818009010223), received between Jun 17, 2016 and Dec 19, 2025 — classified as 1 death, 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2025Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG) AN EXCLUDER CUFF (NON-ENDOLOGIX) ON (B)(6) 2016. IN 2023, ANKLE-BRACHIAL INDEX (ABI) WAS 1.0. IN 2024, ABI WAS 0.9. IN 2025, ABI WAS LESS THAN 0.9 AND THE PATIENT'S PULSE WAS PALPABLE BUT PERCEIVED AS SLIGHTLY WEAK. CONTRAST CT SHOWED THE DISTAL END OF THE AFX (BSG) RIGHT LEG APPEARED TO BE LEANING INWARD. AN INTERVENTION FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND ADDITIONAL BARE STENT PLACEMENT WAS BEING CONSIDERED. ON (B)(6) 2025 THE PATIENTS WAS IN POOR CONDITION DUE TO ISSUES AT A SITE UNRELATED TO THIS EVENT. THE PHYSICIAN ELECTED TO NOT PERFORM THE PROCEDURE.

  Patient problems: Stenosis

  MAUDE report 23856825 ↗
• InjuryAug 13, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2017 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX CUFF. APPROXIMATELY EIGHT YEARS POST INITIAL PROCEDURE, ROUTINE FOLLOW UP, CONFIRMED THE JUNCTION WAS ABOUT TO SEPARATE. REINTERVENTION WAS COMPLETED ON (B)(6) 2025. THE INTRAOPERATIVE ANGIOGRAPHY CONFIRMED A TYPE IIIA ENDOLEAK. A AFX VELA INFRARENAL WAS IMPLANTED AT THE CENTER OF THE JUNCTION VIA THE LEFT ACCESS. THE PROCEDURE WAS COMPLETED AFTER PERFORMING BALLOON TOUCH UP.

  Patient problems: Clinical Endoleak

  MAUDE report 22797531 ↗
• InjuryJun 17, 2024Material 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 TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2017 WITH THE IMPLANT OF AN AFX MAIN BODY AND AN AFX VELA SUPRARENAL STENT GRAFT. AT THAT TIME A GORE EXCLUDER (NON-ENDOLOGIX) STENT WAS ADDED IN THE LEFT LEG AS WELL AS A CORDIS SMART (NON-ENDOLOGIX) STENT WAS ADDED IN THE RIGHT LEG. 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. ANEURYSM ENLARGEMENT WAS OBSERVED ON 21 MAY 2024 BY COMPARING WITH THE FOLLOW-UP DATA FROM OCT 2020 AND APRIL 2024, APPROXIMATELY 10MM ENLARGEMENT. ENDOLEAK WAS IDENTIFIED HOWEVER THE TYPE IS NOT DETERMINED. THE ADDITIONAL TREATMENT PLAN IS BEING DISCUSSED. PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19550268 ↗
• InjuryFeb 15, 2022Off-Label Use; Separation Problem; Off-Label Use; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 6 YEARS POST INITIAL PROCEDURE, A TYPE 3A ENDOLEAK WAS IDENTIFIED DURING A ROUTINE FOLLOW UP. AN INTERVENTION HAS BEEN SCHEDULED. THE PATIENT WAS REPORTED AS DOING FINE. AFTER THE INITIAL REPORT CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST A TYPE II ENDOLEAK (NON-DEVICE RELATED) OF THE LUMBAR ARTERY OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE TYPE II ENDOLEAK WAS DISCOVERED DURING A REVIEW OF THE 69-MONTH POST INDEX COMPUTERIZED TOMOGRAPHY SCAN.

  Patient problems: Failure of Implant

  MAUDE report 13535854 ↗
• DeathSep 12, 2020Material Puncture/Hole; Material Integrity Problem; Material Puncture/Hole; Material Integrity Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A AFX BIFURCATED STENT GRAFT AND A VELA INFRARENAL STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS POST INITIAL IMPLANT, A TYPE 3B ENDOLEAK WITH SAC GROWTH WAS IDENTIFIED ON A CT (COMPUTED TOMOGRAPHY), THE PATIENT IS CURRENTLY STABLE AND AN INTERVENTION IS BEING PLANNED.

  Patient problems: Aneurysm; Death; Failure of Implant

  MAUDE report 10526053 ↗
• InjurySep 3, 2020Patient-Device Incompatibility; Separation Problem; Patient-Device Incompatibility; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND AN AFX INFRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS LATER, THE PATIENT PRESENTED SYMPTOMATIC WHERE AN EXAMINATION REVEALED A TYPE 3A ENDOLEAK WITH COMPLETE SEPARATION OF THE AFX BIFURCATED STENT GRAFT AND THE INFRARENAL STENT GRAFT EXTENSION. THE PHYSICIAN PERFORMED AN OPEN CONVERSION SURGERY, EXPLANTED THE DEVICES, AND TREATED THE PATIENT WITH A NON-ENDOLOGIX AORTIC GRAFT. THE SURGERY WAS SUCCESSFUL AND THE PATIENT WAS REPORTEDLY IN STABLE CONDITION. THE EXPLANTED DEVICES WERE BOTH DISPOSED OF AT THE HOSPITAL.

  Patient problems: Failure of Implant; Hematoma

  MAUDE report 10488792 ↗
• InjuryNov 21, 2018Leak/Splash; Leak/Splash

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS PATIENT HAS BEEN REPORTED TO HAVE A TYPE 2 ENDOLEAK WITH SAC GROWTH IN THE PAST WITH NO INTERVENTION REPORTED. NOW IT HAS BEEN REPORTED THAT THIS PATIENT STILL HAS THE TYPE 2 ENDOLEAK WITH SAC GROWTH BUT MAY ALSO HAVE A TYPE 3A ENDOLEAK. THE PHYSICIAN IS CURRENTLY PLANNING A AN INTERVENTION. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8097853 ↗
• InjurySep 13, 2018Leak/Splash; Leak/Splash

  ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH A BIFURCATED STENT GRAFT AND TWO (2) SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON 08/14/2018, ENDOLOGIX WAS MADE AWARE OF A PATIENT DEATH. THE PATIENT PRESENTED EMERGENTLY TO THE EMERGENCY ROOM WITH A RUPTURE AORTIC ANEURYSM FROM A TYPE IIIA ENDOLEAK. THE PHYSICIAN PERFORMED SURGICAL INTERVENTION BUT WAS UNSUCCESSFUL. THE PATIENT EXPIRED THE FOLLOWING DAY ON (B)(6) 2018.

  Patient problems: Death; Failure of Implant

  MAUDE report 7872851 ↗
• InjuryFeb 13, 2018Biocompatibility; Biocompatibility

  ON (B)(6) 2018, ENDOLOGIX WAS INFORMED OF AN EXPLANT ON A PATIENT DUE TO POSSIBLE STENT GRAFT INFECTION. THE PATIENT'S AX2 MAIN BODY AND SUPRARENAL PROXIMAL EXTENSION WERE REMOVED ON (B)(6) 2017. NO OTHER INFORMATION WAS PROVIDED REGARDING PATIENT CONDITION POST OP EXPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 7267438 ↗
• InjuryJan 24, 2018Hole In Material; Leak/Splash; Material Integrity Problem; Hole In Material; Leak/Splash; Material Integrity Problem

  ON (B)(6) 2014, THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL EXTENSION. ON (B)(6) 2017, ENDOLOGIX WAS MADE AWARE OF A TYPE 3A AND 2 ENDOLEAKS WITH SAC GROWTH. ON (B)(6) 2017, THE PHYSICIAN DISCOVERED MIGRATION OF THE EXTENSION DURING THE SECONDARY PROCEDURE. THE PHYSICIAN ELECTED TO PLACE ANOTHER EXTENSION TO RESOLVE THIS REPORTED EVENT. THE PATIENT WILL BE MONITORED. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. THIS EVENT WAS PREVIOUSLY REPORTED UNDER 2031527-2017-00607. DURING THE CLINICAL ASSESSMENT OF THE ABOVE REPORTED, A TYPE 3B ENDOLEAK OF THE MAIN BODY WAS DISCOVERED ON (B)(6) 2018. THE PATIENT IS BEING MONITORED. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. THIS REPORT IS ONLY FOR THE BIFURCATED STENT GRAFT (MAIN BODY) FOR THE TYPE 3B ENDOLEAK.

  Patient problems: Failure of Implant

  MAUDE report 7215986 ↗
• InjuryJan 11, 2018Hole In Material; Leak/Splash; Material Integrity Problem; Hole In Material; Leak/Splash; Material Integrity Problem

  ON (B)(6) 2017, AN EVAR WAS PERFORMED FOR A PATIENT WITH ABDOMINAL AORTIC ANEURYSM. A BIFURCATED STENT AND PROXIMAL EXTENSION WERE IMPLANTED. AN ANGIOGRAPHY WAS PERFORMED AND IT SHOWED AN ENDOLEAK FROM THE DISTAL PORTION (RIGHT SIDE) OF BIFURCATED STENT. THE PHYSICIAN ELECTED TO RELINE THE BIFURCATED STENT AREA WITH ANOTHER PROXIMAL EXTENSION. ANOTHER ANGIOGRAPHY SHOWED THAT THE ENDOLEAK HAS DECREASED BUT DID NOT COMPLETELY DISAPPEAR. ON (B)(6) 2017, DURING A FOLLOW UP, IT WAS REPORTED THAT A CT SHOWED THAT THE ENDOLEAK HAD DISAPPEARED AND THE ANEURYSM SIZE HAD DECREASED. THE PATIENT IS CURRENTLY BEING MONITORED AND THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7183856 ↗
• MalfunctionAug 24, 2017Detachment Of Device Component; Difficult or Delayed Positioning; Physical Resistance; Detachment Of Device Component; Difficult or Delayed Positioning; Physical Resistance

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT WAS IMPLANTED WITH AN AFX BIFURCATED DEVICE FOR AN ABDOMINAL ANEURYSM. DURING THE DEPLOYMENT OF THE CONTRALATERAL LIMB, RESISTANCE WAS FELT, THE PHYSICIAN CONTINUED TO PULL THE SURPASS WIRE AND IT WAS REMOVED FROM THE BODY. HOWEVER, IT WAS NOTED THAT THE CONTRALATERAL LIMB COVERED WAS STILL ATTACHED TO THE STENT GRAFT AND THE CONTRALATERAL LIMB WAS NOT COMPLETELY DEPLOYED. A SNARE CATHETER WAS INSERTED AND THE COVER WAS REMOVED FROM THE MAIN BODY TO SUCCESSFULLY DEPLOY THE MAIN BODY. THE SUREPASS WIRE WAS REMOVED AND INSPECTED, IT WAS CONFIRMED THAT THE PROXIMAL BEAD WAS MISSING. THE CUFF WAS IMPLANTED WITHOUT ISSUE. THERE HAVE BEEN NO PATIENT SEQUELAE REPORTED.

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

  MAUDE report 6817903 ↗
• InjuryJun 4, 2017Failure To Adhere Or Bond; Leak/Splash; Patient-Device Incompatibility; Failure To Adhere Or Bond; Leak/Splash; Patient-Device Incompatibility

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION. A FOLLOW UP SHOWED THE PATIENT HAD A POTENTIAL TYPE 2 OR TYPE 3A ENDOLEAK. THE PHYSICIAN IS PLANNING TO COMPLETE AN ANGIOGRAM TO CONFIRM THE TYPE OF ENDOLEAK. TO DATE AN ANGIOGRAM HAS NOT BEEN COMPLETED. THERE HAVE ALSO BEEN NO REPORTS OF A SECONDARY INTERVENTION AND NO ADDITIONAL ADVERSE EVENTS HAVE BEEN REPORTED FOR THIS PATIENT.

  Patient problems: Failure of Implant; Stenosis

  MAUDE report 6610429 ↗
• InjuryJan 25, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  DURING INITIAL IMPLANT OF BIFURCATED STENT THE PHYSICIAN HAD DIFFICULTY DEPLOYING THE STENT. THE PHYSICIAN HAD TROUBLE DEPLOYING THE CONTRA LATERAL LIMB AND WAS NOT ABLE TO PULL DOWN THE SURE PASS WIRE. AFTER TROUBLESHOOTING THE DEPLOYMENT WAS SUCCESSFUL. DURING A FINAL ANGIOGRAM RUN THE PHYSICIAN IDENTIFIED A DISSECTION IN THE RIGHT EXTERNAL ILIAC ARTERY. AN ADDITIONAL NON-ENDOLOGIX STENT WAS PLACED TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED AND THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT

  Patient problems: Vascular Dissection

  MAUDE report 6278214 ↗
• InjurySep 30, 2016Occlusion Within Device; Occlusion Within Device

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT HAD A FOLLOW UP, THE PHYSICIAN IDENTIFIED A LEFT LIMB OCCLUSION. THE PATIENT WAS NOT SYMPTOMATIC. THE PHYSICIAN COMPLETED A THROMBECTOMY AND IMPLANTED A NON-ENDOLOGIX STENT TO REGAIN PATENCY. THE PATIENT IS STABLE.

  Patient problems: Claudication; Ischemia; Occlusion; Thrombus

  MAUDE report 5990927 ↗
• MalfunctionJun 17, 2016Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION ON (B)(6) 2015. A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN ON (B)(6) 2015 SHOWED A POTENTIAL TYPE 2 ENDOLEAK OR A TYPE 3 ENDOLEAK WITH ANEURYSM SAC GROWTH. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. THE PATIENT HAD AN ADDITIONAL FOLLOW UP ON (B)(6) 2016 AND THE CT STILL SHOWED A POTENTIAL TYPE 2 ENDOLEAK OR A TYPE 3 ENDOLEAK WITH CONTINUED ANEURYSM SAC GROWTH. THE PHYSICIAN HAS NOT PLANNED A SECONDARY INTERVENTION. THE PATIENT IS ASYMPTOMATIC AND IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 5734074 ↗

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-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-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-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-0590-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• 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-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-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-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.