AFX Endovascular AAA System A25-25/C75Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00818009010285), received between Jul 21, 2016 and Apr 13, 2018 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2018Leak/Splash; Unintended Movement; Leak/Splash; Unintended Movement

  ON (B)(6) 2018 A BIFURCATED STENT GRAFT AND PROXIMAL EXTENSION WERE IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. UPON DEPLOYMENT AND BALLOON TOUCH UP OF AN AFX PROXIMAL EXTENSION, AN ANGIOGRAM SHOWED A TYPE IA ENDOLEAK DUE TO THE PROXIMAL EXTENSION MOVING SLIGHTLY DISTALLY INTO THE ANEURYSM SAC. PHYSICIAN ELECTED TO IMPLANTED A SECOND PROXIMAL EXTENSION, HOWEVER, THE TYPE IA ENDOLEAK PERSISTED. THE PROCEDURE WAS CONCLUDED AND THE PATIENT IS TO BEING MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 7429204 ↗
• InjuryMar 30, 2018Occlusion Within Device; Deformation Due to Compressive Stress; Occlusion Within Device; Deformation Due to Compressive Stress

  ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH A BIFURCATED STENT, AN INFRARENAL EXTENSION AND A NON-ENDOLOGIX STENT. ON (B)(6) 2018, THE PATIENT HAD A ROUTINE 1-MONTH FOLLOW UP. THE PATIENT COMPLAINED OF CLAUDICATION OF THE BUTTOCK. A FOLLOW UP CT IMAGE WAS PERFORMED. THE INFRARENAL EXTENSION WAS DISCOVERED TO BE BUCKLED (IN-FOLDED) AND THE EXTENSION INNER-LUMEN WAS OCCLUDED BY THROMBOSIS. IT WAS NOTED THAT THE BIFURCATED STENT AND NON- ENDOLOGIX STENT WERE NOT DEFORMED OR OCCLUDED. ON (B)(6) 2018, THE PHYSICIAN EXPANDED THE DEFORMED INFRARENAL EXTENSION BY BALLOONING. THE PHYSICIAN ELECTED TO IMPLANT TWO (2) NON- ENDOLOGIX STENTS AND LIMB EXTENSION TO RESOLVE THIS EVENT. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Claudication; Failure of Implant; Occlusion; Thrombosis

  MAUDE report 7386065 ↗
• InjuryAug 15, 2017Failure To Adhere Or Bond; Leak/Splash; Unintended Movement; Failure To Adhere Or Bond; Leak/Splash; Unintended Movement

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A INFRARENAL AORTIC EXTENSION. ON (B)(6) 2017 THE PATIENT HAD A FOLLOW UP COMPUTED TOMOGRAPHY (CT) WHICH SHOWED THE PATIENT HAD A TYPE 2 ENDOLEAK. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT, NO TREATMENT OF THE ENDOLEAK WAS COMPLETED. IN (B)(6) 2017, A CT WAS COMPLETED AND SHOWED THE FOLLOWING; ENLARGEMENT OF THE DISTAL RIGHT COMMON ILIAC ARTERY (RCIA), AORTIC ANEURYSM SAC GROWTH, MOVEMENT OF THE PROXIMAL STENT, A SUSPECTED TYPE 1A ENDOLEAK, A TYPE 2 ENDOLEAK AND A STRUT FROM THE PROXIMAL CUFF PROTRUDING INTO THE ANEURYSM LUMEN. ON (B)(6) 2017 THE PATIENT HAD A SECONDARY PROCEDURE TO RESOLVE THE ENDOLEAKS. THE PHYSICIAN IMPLANTED A VASCULAR PLUG AS WELL AS A COIL TO TREAT THE TYPE 2 ENDOLEAK. THE PHYSICIAN IMPLANTED A NON-ENDOLOGIX GORE EXCLUDER IN THE PROXIMAL AORTA TO SEAL THE TYPE 1A ENDOLEAK AND AN ADDITIONAL NON-ENDOLOGIX GORE EXCLUDER IN THE RCIA TO ADDRESS THE REPORTED ANEURYSM ENLARGEMENT. WITH THE PLACEMENT OF THE PROXIMAL GORE DEVICE THE REPORTED PROTRUDING STRUT WAS RESOLVED. A FINAL ANGIOGRAPHY SHOWED THE TYPE 1A ENDOLEAK WAS SUCCESSFULLY SEALED AND A TYPE 2 ENDOLEAK WAS STILL REMAINING. IT WAS REPORTED T

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 6795674 ↗
• MalfunctionJul 21, 2016Hole In Material; Leak/Splash; Hole In Material; Leak/Splash

  IT WAS REPORTED THAT AFTER DEPLOYMENT OF THE BIFURCATED AND INFRARENAL AORTIC EXTENSION DURING THE INITIAL PROCEDURE ON (B)(6) 2016, AN ANGIOGRAPHY WAS PERFORMED WHICH REVEALED A SUSPECTED PINHOLE ON THE AORTIC EXTENSION. PHYSICIAN RELINED WITH AN INFRARENAL AORTIC EXTENSION TO CORRECT THE LEAK, BUT NOTED THAT THE ENDOLEAK HAD ONLY DECREASED SO ELECTED TO TREAT WITH A PROTAMINE WHICH DID RESOLVE THE LEAK. PATIENT IS IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 5814290 ↗

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-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-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-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-0596-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL
• 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-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-0590-06 · 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

…and 1 more.