Vela Proximal Endograft System A28-28/C95 VRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00818009013521), received between Feb 16, 2016 and Jul 16, 2025 — classified as 14 injuries.

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE AND A HALF (3.5) YEARS POST INITIAL PROCEDURE, A TYPE 1A ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN ELECTED TO IMPLANT AN AFX VELA INFRARENAL ON (B)(6) 2025 WHICH SUCCESSFULLY RESOLVED THE ENDOLEAK.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 22522661 ↗
• InjuryJun 13, 2024Off-Label Use; Improper or Incorrect Procedure or Method; Unintended Movement; Off-Label Use; Improper or Incorrect Procedure or Method; Unintended Movement

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA INFRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) AFTER OCCLUDING THE INTERNAL MAMMARY ARTERY. ANGIOGRAM AFTER TOUCH UP SHOWED THE VELA INFRARENAL HAD MIGRATED DOWNWARD AND PRODUCED A TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT A GORE (NON-ENDOLOGIX) CUFF BELOW THE RENAL ARTERY WHICH RESOLVED THE ENDOLEAK. 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. IT WAS THEN REPORTED THAT THE GORE CUFF COVERED BOTH RENAL ARTERIES BUT THERE WAS STILL BLOOD FLOW. THE PHYSICIAN THEN ATTEMPTED TO PULL THE GORE CUFF DOWN WITH THE BALLOON BUT FAILED. THE BALLOONS EXPANSION CAUSED THE GRAFT TO BLOCK THE BLOOD FLOW TO THE LEFT ARTERY. THE PHYSICIAN THEN ATTEMPTED TO CANNULATE THE LEFT ARTERY FOR AN HOUR, BUT IT FAILED. THE PHYSICIAN THEN ELECTED TO ADD AN UNNAMED (NON-ENDOLOGIX) STENT TO THE RIGHT RENAL ARTERY. THE PHYSICIAN THEN ATTEMPTED TO CANNULATE THE LEFT RENAL ARTERY FOR THREE (3) HOURS BUT WAS UNABLE TO PASS THE GUIDING CATHETER. THE GUIDE WIRE RELEASED FROM THE ARTERY AND WHEN IT

  Patient problems: Clinical Endoleak

  MAUDE report 19533838 ↗
• InjuryMay 24, 2024Migration; Migration

  JOURNAL ARTICLE OKUBO RENAL RESCUE AFTER INADVERTENT COVERAGE DURING ENDOVASCULAR ANEURYSM REPAIR REPORTED THAT A 75-YEAR-OLD MAN HAD UNDERGONE EVAR FOR AN AAA AT ANOTHER HOSPITAL 3 YEARS BEFORE ADMISSION AND WAS FOLLOWED UP AT OUR OUTPATIENT CLINIC. HE WAS IN A FRAIL STATE AFTER A BRAIN HEMORRHAGE AND HAD A HISTORY OF PAROXYSMAL ATRIAL FIBRILLATION AND HYPERTENSION, IN ADDITION TO DELIRIUM AFTER THE PREVIOUS EVAR. THE AFX ENDOVASCULAR AAA SYSTEMS BEA25-90/I16-30 AND A28-28/C95- O20 V (ENDOLOGIX) WERE USED IN THE PREVIOUS SURGERY. PLAIN COMPUTED TOMOGRAPHY (CT) REVEALED AN INCREASE IN THE ANEURYSM DIAMETER OVER TIME (50 MM AT THE FIRST VISIT AND 55 MM BEFORE ADMISSION) AND MIGRATION OF THE PROXIMAL EXTENSION TO THE DISTAL REGION. CONTRAST-ENHANCED CT REVEALED A TYPE IA ENDOLEAK FROM THE DORSAL SIDE (FIG 1). THE PROXIMAL NECK HAD NO CALCIFICATION OR THROMBUS, AND THE LENGTH AND DIAMETER WERE 18MM AND 25 MM, RESPECTIVELY. THE NECK ANEURYSM ANGULATION WAS 55_. ENDOVASCULAR TREATMENT WAS CONSIDERED APPROPRIATE DUE TO THE PATIENT¿S CLINICAL HISTORY, AND AN AORFIX PROXIMAL EXTENSION (LOMBARD MEDICAL) WAS ADDED BECAUSE OF ITS PURPORTED ABILITY TO ACCOMMODATE NECK FLEXION EFFECTIVELY. THE

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19394916 ↗
• InjuryAug 14, 2023Migration; Migration

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL ON (B)(6) 2020. IT WAS REPORTED ON (B)(6) 2023, THAT THE AFX VELA INFRARENAL HAD MIGRATED AND THERE IS A TYPE IA ENDOLEAK. PATIENT STATUS AND TREATMENT PLAN HAVE NOT BEEN PROVIDED. NOTE: THE DATE OF EVENT IS ESTIMATED BASED ON THE REPORTED INFORMATION.

  Patient problems: Clinical Endoleak

  MAUDE report 17542064 ↗
• InjuryApr 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND AN INFRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) DAYS POST INITIAL PROCEDURE, A COMPUTED TOMOGRAPHY (CT) SHOWED THE PROXIMAL PORTION OF AORTIC EXTENSION APPEARED TO BE KINKED AND THERE WAS A POSSIBLE TYPE 1A ENDOLEAK. THE PATIENT IS FINE AND CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Failure of Implant

  MAUDE report 11661465 ↗
• InjuryAug 17, 2018Leak/Splash; Migration or Expulsion of Device; Migration; Leak/Splash; Migration or Expulsion of Device; Migration

  ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH A BIFURCATED STENT GRAFT AND AN INFRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE OF A TYPE 1A ENDOLEAK WITH STENT MIGRATION. ON (B)(6) 2018, THE PHYSICIAN ELECTED TO IMPLANT A SUPRARENAL EXTENSION TO RESOLVE THIS LEAK. THE PATIENT WAS REPORTED AS DOING FINE AND THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7795276 ↗
• InjuryJun 20, 2018Leak/Splash; Leak/Splash

  AT THE COMPLETION OF THE CLINICAL ASSESSMENT ON (B)(6) /2018 FOR A PERVIOUS REPORT EVENT (2031527-2017-00219), CLINICAL WAS ABLE TO FIND SUBSTANTIAL EVIDENCE TO SUPPORT THE FOLLOWING ADDITIONAL FINDINGS OF TYPE IB ENDOLEAK OF THE LEFT COMMON ILIAC ARTERY. THIS REPORT IS FOR THE TYPE IB ENDOLEAK ONLY.

  Patient problems: Failure of Implant

  MAUDE report 7623475 ↗
• InjuryJan 3, 2018Failure To Adhere Or Bond; Leak/Splash; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Failure To Adhere Or Bond; Leak/Splash; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND TWO INFRARENAL AORTIC EXTENSIONS. THE PATIENT CAME IN EMERGENTLY ON (B)(6) 2017 WITH SEVERE ABDOMINAL PAIN. THE PHYSICIAN IDENTIFIED A MIGRATION OF THE PROXIMAL EXTENSION AND A TYPE 1A ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT TWO INFRARENAL AORTIC EXTENSIONS AND TWO NON-ENDOLOGIX RENAL STENTS TO COMPLETE A CHIMNEY PROCEDURE. THE PATIENT IS REPORTED TO BE DOING WELL POST PROCEDURE. THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

  Patient problems: Aneurysm; Failure of Implant; Pain; Rupture

  MAUDE report 7162685 ↗
• InjuryDec 18, 2017Collapse; Folded; Collapse; Folded

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND AN INFRARENAL AORTIC EXTENSION. ON (B)(6) 2017 THE PATIENT CAME IN EMERGENTLY WITH A COLD LEG. COMPUTED TOMOGRAPHY (CT) SHOWED THE PATIENT HAD AN OCCLUSION FROM THE PROXIMAL EXTENSION WHICH WAS REPORTED TO HAVE COLLAPSED. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICES AND COMPLETE AN OPEN REPAIR. THE DEVICES WERE DISCARDED AT THE HOSPITAL. THE PATIENT IS REPORTED TO BE IN GOOD CONDITION AND THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED.

  Patient problems: Blood Loss; Claudication; Failure of Implant; Ischemia; Occlusion; Thrombosis

  MAUDE report 7124558 ↗
• InjuryNov 15, 2017Failure To Adhere Or Bond; Leak/Splash; Migration or Expulsion of Device; Patient-Device Incompatibility; Failure To Adhere Or Bond; Leak/Splash; Migration or Expulsion of Device; Patient-Device Incompatibility

  PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED, ONE INFRARENAL, ONE SUPRARENAL AND TWO LIMB EXTENSION ON (B)(6) 2016. DURING A ROUTINE FOLLOW UP, THE PHYSICIAN NOTED AN ENDOLEAK TYPE IA THROUGH ULTRASOUND. THE PHYSICIAN ELECTED TO RELINE WITH A GORE TAG DEVICE. THE LEAK WAS RESOLVED AND THE PATIENT WAS REPORTED TO BE DOING WELL POST PROCEDURE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7035840 ↗
• InjurySep 15, 2017Failure To Adhere Or Bond; Leak/Splash; Migration or Expulsion of Device; Unintended Movement; Failure To Adhere Or Bond; Leak/Splash; Migration or Expulsion of Device; Unintended Movement

  A PATIENT PREVIOUSLY IMPLANTED WITH AFX DEVICES TO REPAIR AN ABDOMINAL AORTIC ANEURYSM RETURNED FOR A ROUTINE FOLLOW UP. DURING THE FOLLOW-UP, PHYSICIAN NOTED 9 CM ANEURYSM GROWTH AND PERSISTENT ENDOLEAK. VELA CUFF HAD FALLEN OUT OF THE NECK INTO THE ANEURYSM SAC. THE PATIENT WAS INITIALLY IMPLANTED IN (B)(6) 2011 AND IN 2015, DUE TO AN ENDOLEAK, HAD AN ADDITIONAL AORTIC EXTENSION PLACED. PHYSICIAN ELECTED TO EXPLANT THE DEVICE. DURING THE EXPLANT, A FABRIC TEAR WAS NOTED ON THE ORIGINAL AFX MAIN BODY AND THE AORTIC EXTENSION HAD COMPLETELY SEPARATED FROM THE SUPRARENAL FIXATION. THE PATIENT IS REPORTED AS STABLE AFTER THE PROCEDURE. DURING THE COMPLETION OF THE CLINICAL ASSESSMENT FOR THIS EVENT ON (B)(6) 2017, CLINICAL WAS ABLE TO FIND SUBSTANTIAL EVIDENCE TO SUPPORT THE FOLLOWING REPORTED EVENT; STENT MIGRATION OF THE VELA CUFF (SECOND AORTIC CUFF) AS WELL AS OTHER FINDINGS THEREFORE THIS REPORT WAS CREATED FOR THE STENT MIGRATION OF THIS VELA CUFF.

  Patient problems: Failure of Implant

  MAUDE report 6870699 ↗
• InjuryDec 30, 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) 2013. ON (B)(6) 2014 COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) SHOWED ANEURYSM SAC GROWTH FROM 5.7 CM TO 6.3 CM. ON (B)(6) 2014 THE CTA SHOWED ADDITIONAL ANEURYSM SAC GROWTH TO 7 CM, NO ENDOLEAK WAS IDENTIFIED. ON (B)(6) 2014 A TYPE 2 ENDOLEAK WAS IDENTIFIED AND THE PATIENT UNDERWENT A COIL EMBOLIZATION, THE PHYSICIAN NOTED CONTINUED SAC EXPANSION TO 8 CM. ON (B)(6) 2014 THE PATIENT HAD AN ADDITIONAL COILING PROCEDURE. ON (B)(6) 2014 THE PATIENT HAD A SUSPECTED TYPE 3A ENDOLEAK AND THE PHYSICIAN ELECTED TO IMPLANT AN INFRARENAL AORTIC EXTENSION TO SEAL THE LEAK. ON (B)(6) 2015 AN UNKNOWN ENDOLEAK WAS IDENTIFIED AND ON (B)(6) 2015 AN ADDITIONAL INFRARENAL AORTIC EXTENSION WAS PLACED TO SEAL THE ENDOLEAK. THE PROCEDURE WAS COMPLETED AND NO ADDITIONAL ADVERSE EVENTS WERE REPORTED FOR THIS PATIENT.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 6216668 ↗
• InjuryOct 21, 2016Difficult or Delayed Positioning; Malposition of Device; Activation, Positioning or Separation Problem; Difficult or Delayed Positioning; Malposition of Device; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE ON (B)(6) 2016, THE PHYSICIAN HAD A DEPLOYMENT ISSUE WITH THE BIFURCATED DEVICE. THE DEPLOYMENT CORD ON THE BIFURCATED DEVICE WAS TOO TIGHT AND AFTER SEVERAL ATTEMPTS AT PULLING THE CORD, THE CORD BROKE. IN TRYING TO REMOVE THE DEVICE FROM THE PATIENT THE DEVICE UNINTENTIONALLY DEPLOYED IN A SUB OPTIMAL POSITION. FOLLOWING THE BIFURCATED STENT DEPLOYMENT THE PHYSICIAN DEPLOYED A PROXIMAL EXTENSION AS WELL AND WAS NOT ABLE TO ACHIEVE A SEAL TO SUCCESSFULLY EXCLUDE THE ANEURYSM. IT WAS REPORTED THE INITIAL IMPLANTS ARE CURRENTLY NOT ANCHORED PROPERLY WITHIN THE AORTA AND THERE HAS NOT BEEN A SCHEDULED INTERVENTION AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 6046228 ↗
• InjuryFeb 16, 2016Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2015 WITH A BIFURCATED AND A INFRARENAL AORTIC EXTENSION. PATIENT CAME IN EMERGENTLY FOR CRITICAL LIMB ISCHEMIA ON (B)(6) 2015. COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) SHOWED THE PATIENT HAD A KINK IN THE IMPLANTED ENDOGRAFT. THE PHYSICIAN ELECTED TO IMPLANT AN INFRARENAL AORTIC EXTENSION TO RESOLVE THE ISSUE. POST PROCEDURE THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 5438509 ↗

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