AFX Endovascular AAA System BA22-70/I16-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00818009010094), received between Apr 8, 2016 and Jun 15, 2023 — classified as 1 death, 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND SUPRARENAL AORTIC EXTENSION. APPROXIMATELY SIX AND A HALF (6.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IIIA OR IIIB ENDOLEAK (INDETERMINATE ORIGIN). THE PATIENT WAS ORIGINALLY SCHEDULED FOR RE-INTERVENTION, BUT THE SURGERY WAS POSTPONED DUE TO THE PATIENT'S CONDITION OF PNEUMONIA. ONCE THE PATIENT HAS RECOVERED, SURGERY WILL BE RESCHEDULED.

  Patient problems: Clinical Endoleak

  MAUDE report 17133830 ↗
• InjuryApr 13, 2022Complete Blockage; Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Separation Problem; Complete Blockage; Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; 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 PATIENT WAS IDENTIFIED WITH A RAPIDLY ENLARGED ANEURYSM AND AN IMPENDING RUPTURE DUE TO A TYPE IIIA ENDOLEAK. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICES WHICH WERE DISPOSED OF AFTER THE PROCEDURE. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Aneurysm; Failure of Implant; Obstruction/Occlusion

  MAUDE report 14104520 ↗
• InjuryMar 8, 2022Insufficient 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. REPORTEDLY, DURING AN EXPLANT OF THESE DEVICES THE PHYSICIAN IDENTIFIED THAT THE PATIENT WAS ALSO IMPLANTED WITH AN AFX INFRARENAL EXTENSION AT SOME POINT BETWEEN POST INITIAL PROCEDURE ((B)(6) 2016) AND THE OPEN REPAIR/EXPLANT ((B)(6) 2022). IT IS UNKNOWN WHY THE AFX INFRARENAL EXTENSION WAS IMPLANTED. NOTE: THE EXPLANT WAS REPORTED UNDER CFN# 2031527-2022-0004.

  Patient problems: Insufficient Information

  MAUDE report 13694610 ↗
• InjuryMar 4, 2022Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 6 YEARS POST INITIAL PROCEDURE PATIENT WAS IDENTIFIED WITH A TYPE IIIB ENDOLEAK AND THE PHYSICIAN ELECTED TO PERFORM AN EXPLANT. REPORTEDLY, DURING REPAIR IT WAS FOUND THAT THE PATIENT WAS ALSO IMPLANTED WITH AN AFX INFRARENAL EXTENSION AT SOME POINT BETWEEN POST INITIAL PROCEDURE AND THE EXPLANT; THIS EVENT WILL BE REPORTED UNDER A SEPARATE MEDICAL DEVICE REPORT.

  Patient problems: Failure of Implant

  MAUDE report 13667084 ↗
• DeathMar 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A VELA SUPRARENAL STENT GRAFT EXTENSION, AND A VELA INFRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 6.5 YEARS POST INITIAL IMPLANT, A TYPE 3 ENDOLEAK OF UNKNOWN ORIGIN WITH SUDDEN SAC EXPANSION AND RUPTURE OCCURRED. IT WAS REPORTED THAT THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS NOT PROVIDED. NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFORMATION: THE CLINICAL EVALUATION SHOWS REASONABLE EVIDENCE TO SUGGEST ENDOVASCULAR PROCEDURES OF COILING OF TYPE II ENDOLEAKS OF THE LUMBAR ARTERIES OCCURRED. THESE FINDINGS WERE DISCOVERED DURING AN EXAMINATION OF THE ANGIOGRAM STUDIES. A TYPE II ENDOLEAK IS A NON DEVICE RELATED FAILURE.

  Patient problems: Aneurysm; Failure of Implant; Rupture

  MAUDE report 11489394 ↗
• InjuryApr 22, 2019Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED CONFIRMING THAT A LEFT-SIDE LIMB THROMBECTOMY WAS PERFORMED WITH BARE METAL STENTS IN THE LEFT COMMON AND EXTERNAL ILIACS, AND THE DISTAL RIGHT-SIDE COMMON ILIAC WAS ANGIOPLASTIED ON (B)(6) 2019. THE VESSELS ARE PATENT AND THE PATIENT IS REPORTEDLY DOING WELL. CLINICAL ASSESSMENT CONFIRMED THAT THE INITIAL CASE WAS OFF-LABEL USE DUE TO THE PATIENT'S AORTO-ILIAC OCCLUSIVE DISEASE (AIOD). IN ADDITION, CLINICAL IDENTIFIED THAT DISTAL AORTIC STENOSIS AND A COMPLETE RIGHT COMMON ILIAC ARTERY (RCIA) OCCLUSION WERE PRESENT AT ONE-DAY POST INITIAL IMPLANT PROCEDURE, AND THAT A LEFT COMMON ILIAC ARTERY (LCIA) OCCLUSION WAS PRESENT AT DISCHARGE AFTER SECONDARY INTERVENTION WAS PERFORMED.

  Patient problems: Occlusion; Stenosis; Thrombosis

  MAUDE report 8537917 ↗
• InjuryFeb 8, 2018Bent; Partial Blockage; Off-Label Use; Deformation Due to Compressive Stress; Bent; Partial Blockage; Off-Label Use; Deformation Due to Compressive Stress

  THIS PATIENT HAD AN AFX GRAFT PLACED ON (B)(6) 2016 TO TREAT AORTIC STENOSIS. THROUGH REGULAR FOLLOW UP, AN UPDATED SCAN REVEALED THAT THE MAIN BODY GRAFT APPEARED TO BE PINCHED IN OR NARROWED A BIT AT THE AREA OF THE STENOSIS. THE PHYSICIAN ELECTED TO PLACED A BARE METAL AND BALLOON EXPANDABLE STENT TO OPEN THE AREA. THE PHYSICIAN WAS PLEASED WITH THE ANGIOGRAPHIC RESULT AND THE PATIENT WILL BE MONITORED MOVING FORWARD. NO ADDITIONAL PATIENT SEQUELAE HAS BEEN REPORTED AT THIS TIME.

  Patient problems: Failure of Implant; Stenosis

  MAUDE report 7251829 ↗
• InjuryApr 8, 2016Failure To Adhere Or Bond; Failure To Adhere Or Bond

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION ON (B)(6) 2014. UPON FOLLOW UP COMPUTED TOMOGRAPHY (CT) SHOWED A POTENTIAL TYPE 3 ENDOLEAK. THE PHYSICIAN ELECTED TO RELINE THE INITIAL IMPLANT WITH AN INFRARENAL AORTIC EXTENSION. DURING THE SECONDARY INTERVENTION THE PHYSICIAN CONFIRMED A TYPE 2 ENDOLEAK ONLY. PATIENT STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 5563000 ↗

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-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-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-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-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-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• Z-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• 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-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• 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-0596-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL

…and 1 more.