Vela Proximal Endograft System A25-25/C75 VRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00818009013491), received between Jul 16, 2017 and Oct 3, 2024 — classified as 2 deaths, 4 injuries.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• DeathOct 3, 2024Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2024. THE PROCEDURE WAS REPORTEDLY OFF-LABEL DUE TO THE PATIENT HAVING A CHALLENGING CALCIFIED ANATOMY. THE AFX VELA INFRARENAL WAS IMPLANTED AND DURING BALLOONING WITH A (NON-ENDOLOGIX) MEDTRONIC RELIANT BALLOON, THE PATIENT'S ABDOMINAL AORTA RUPTURED AT THE LEVEL OF THE RENAL ARTERIES. THIS PROMPTED THE PHYSICIAN TO QUICKLY CONVERT TO AN OPEN SURGICAL REPAIR AND THE AFX VELA INFRARENAL WAS EXPLANTED. IT WAS LATER REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2024 DUE TO COMPLICATIONS FROM THE AORTOBIFEMORAL PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ischemia; Renal Failure; Ruptured Aneurysm

  MAUDE report 20358148 ↗
• InjuryJul 23, 2024Obstruction of Flow; Deformation Due to Compressive Stress; Device-Device Incompatibility; Obstruction of Flow; Deformation Due to Compressive Stress; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL TO TREAT AN INFECTIOUS ANEURYSM. APPROXIMATELY FOUR (4) DAYS POST INITIAL PROCEDURE THE PROXIMAL PORTION OF THE VELA WAS OCCLUDED AND ABI (ANKLE BRACHIAL INDEX) WAS DECREASED. THE PHYSICIAN PERFORMED A SECONDARY PROCEDURE AND ADDED A VIABAHN (NON-ENDOLOGIX) VBX STENT WHERE THE VELA WAS OCCLUDED. THE VBX STENT WAS FULLY EXPANDED AND THE PATIENT'S BLOOD FLOW WAS RESTORED. IT WAS REPORTED THAT THE VBX STENT ALSO OCCLUDED AND THE LOWER LIMB BECAME ISCHEMIC DUE TO THROMBI BELOW THE VELA AND THE PATIENT ALSO SHOWED INTESTINAL NECROSIS AFTER WHICH THE PATIENT PASSED AWAY.

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 19812694 ↗
• InjuryMar 30, 2022Material Puncture/Hole; Material Integrity Problem; Insufficient Device Problem Information; Material Puncture/Hole; Material Integrity Problem; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL PROXIMAL EXTENSION. APPROXIMATELY SIX AND A HALF (6.5) YEARS POST INITIAL PROCEDURE, THE PHYSICIAN EXPLANTED THE DEVICES. THE PATIENT IS REPORTEDLY DOING FINE. IT IS UNKNOWN WHAT PROMPTED THE EXPLANT PROCEDURE OR IF THE DEVICES ARE AVAILABLE FOR RETURN/EVALUATION. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE REGARDING THIS INITIAL REPORT. NOTE: AS THE EXACT DATE OF EVENT (NOR DATE WHEN DEVICE WAS EXPLANTED) IS UNKNOWN, THE BEST ESTIMATE WAS USED, WHICH IS THE MANUFACTURER AWARENESS DATE TO THIS EVENT.

  Patient problems: Failure of Implant

  MAUDE report 13952807 ↗
• InjuryJan 19, 2018Failure To Adhere Or Bond; Leak/Splash; Patient-Device Incompatibility; Failure To Adhere Or Bond; Leak/Splash; Patient-Device Incompatibility

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED AND VELA INFRARENAL DEVICE. DURING A ROUTINE FOLLOW UP CT, IT WAS DISCOVERED THAT THE PATIENT HAD AND ENDOLEAK TYPE IA. THE PHYSICIAN PLACED AN ADDITIONAL ENDOLOGIX CUFF AND A NON-ENDOLOGIX CUFF WITH AN APTUS SCREW TO SUCCESSFULLY SEAL THE LEAK. PATIENT WAS REPORTED TO BE DOING WELL POST REPAIR.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7206307 ↗
• DeathJul 27, 2017Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  BASED ON A FOLLOW-UP COMMUNICATION RECEIVED, IT WAS REPORTED THAT THE PATIENT EXPIRED APPROXIMATELY 2 MONTHS POST-OP; HOWEVER, INFORMATION RELATED TO THE CAUSE OF DEATH WAS NOT REPORTED.

  Patient problems: Aortic Dissection; Blood Loss; Death; Intimal Dissection; Low Blood Pressure/ Hypotension; Occlusion; Renal Failure; Rupture

  MAUDE report 6749267 ↗
• InjuryJul 16, 2017Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  ON (B)(6) 2016 A PATIENT WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH AN AFX SYSTEM. APPROXIMATELY ONE YEAR POST-OP ((B)(6) 2016) A TYPE 1A ENDOLEAK WAS OBSERVED. A RE-INTERVENTION WAS DONE ON AN UNKNOWN DATE AND THE TYPE 1A LEAK WAS RESOLVED. 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 6716517 ↗

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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-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-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-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-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.