Vela Proximal Endograft System A25-25/C95-O20 VRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00818009013620), received between Oct 27, 2017 and Apr 1, 2025 — classified as 1 death, 11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2025Off-Label Use; Material Puncture/Hole; Deformation Due to Compressive Stress; Lack of Effect; Off-Label Use; Material Puncture/Hole; Deformation Due to Compressive Stress; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL AORTIC EXTENSION. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A TYPE 1A ENDOLEAK WAS IDENTIFIED WITH ANEURYSM ENLARGEMENT TO 9CM. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH ANOTHER AFX2 BIFURCATED STENT GRAFT AND EXTENDED PROXIMALLY WITH A VELA SUPRARENAL AORTIC EXTENSION AND SNORKELED (PARALLEL GRAFTED) BOTH RENAL ARTERIES AND THE SUPERIOR MESENTERIC ARTERY (SMA) TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING WELL POST SECONDARY PROCEDURE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 21739636 ↗
• InjuryNov 15, 2022Appropriate Device Problem Term/Code Not Available; Lack of Effect; Appropriate Device Problem Term/Code Not Available; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL PROXIMAL EXTENSION. APPROXIMATELY TWO AND A HALF (2.5) YEARS POST INITIAL PROCEDURE IN SUMMER 2022, THE PATIENT FELL DOWN AND SUFFERED A HEMATOMA IN THE FEMORAL AREA. PATIENT STARTED FEELING BEATS IN THE STOMACH SINCE THEN. AT ROUTINE FOLLOW-UP IN (B)(6) 2022, THE PATIENT PRESENTED WITH A POSSIBLE TYPE IA ENDOLEAK. THE PHYSICIAN PLANS TO RE-INTERVENE BUT SURGERY HAS NOT BEEN SCHEDULED.

  Patient problems: Clinical Endoleak; Failure of Implant

  MAUDE report 15802053 ↗
• InjuryOct 19, 2022Material Puncture/Hole; Appropriate Device Problem Term/Code Not Available; Material Puncture/Hole; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE ENDOVASCULAR IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AFX VELA SUPRARENAL. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE ANEURYSM ENLARGEMENT WITH A TYPE IIIB ENDOLEAK (WITH TWO (2) HOLES) OF THE AFX VELA SUPRARENAL WERE IDENTIFIED. REINTERVENTION WAS COMPLETED BY OPEN REPAIR WITH THE TREATMENT OF FELT BANDS. THE PATIENT STATUS POST-OPEN REPAIR WAS REPORTED TO BE STABLE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 15632932 ↗
• InjuryMar 22, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT, A VELA SUPRARENAL PROXIMAL EXTENSION, AND A LIMB STENT GRAFT. APPROXIMATELY FIVE AND A HALF (5.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IA ENDOLEAK AND ASYMPTOMATIC. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN ADDITIONAL AFX VELA SUPRARENAL ON (B)(6) 2022. THE ENDOLEAK WAS CONFIRMED RESOLVED.

  Patient problems: Failure of Implant

  MAUDE report 13846018 ↗
• InjuryOct 4, 2021Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. ON AN UNKNOWN DATE THE PHYSICIAN ATTEMPTED TO FIX A TYPE II ENDOLEAK WITH COILING THE AAA SAC. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, ANEURYSM ENLARGEMENT WITH A POSSIBLE TYPE 3A AND TYPE IA ENDOLEAK(S), OR JUNCTION LEAK BETWEEN THE AFX BIFURCATED STENT AND THE AFX VELA SUPRARENAL, WERE IDENTIFIED AT ROUTINE FOLLOW-UP. THE PATIENT IS BEING MONITORED AND IS PENDING SCHEDULED REINTERVENTION. SUBSEQUENT TO THE INITIAL REPORT, REINTERVENTION WAS COMPLETED WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. THE PATIENT WAS REPORTED TO BE DOING WELL POST-REINTERVENTION. ADDITIONALLY, CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST TWO (2) ENDOVASCULAR PROCEDURES OCCURRED IN 2017 AND 2019 FOR TREATMENT OF TYPE II ENDOLEAKS (ONE CONFIRMED TO BE THE INTERNAL MESENTERIC ARTERY (NON- DEVICE RELATED FAILURE)) OCCURRED AND ONLY ONE WAS INCLUDED IN THE EVENT AS REPORTED. THE TYPE II ENDOLEAKS AND ENDOVASCULAR PROCEDURES WERE DISCOVERED DURING A REVIEW OF THE DISCHARGE SUMMARY DATED (B)

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12571990 ↗
• InjuryDec 12, 2020Malposition of Device; Malposition of Device

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IA ENDOLEAK DUE TO LOW PLACEMENT (MALPOSITION) OF THE VELA SUPRARENAL DEVICE AT THE INITIAL IMPLANT. THE PATIENT IS REPORTEDLY STABLE BUT HAS REFUSED TREATMENT.

  Patient problems: Failure of Implant

  MAUDE report 10997085 ↗
• DeathNov 18, 2020Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SURARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE A TYPE 1A ENDOLEAK, SAC GROWTH (UNKNOWN DIAMETER), AND A NARROWED PROXIMAL NECK (CLASSIFIED AS STENOSIS) WERE DIAGNOSED DURING A ROUTINE FOLLOW-UP. THE PHYSICIAN ELECTED TO TREAT WITH A (OFF-LABEL) PALMAZ STENT AND 3 CUFFS TO RESOLVE THE TYPE 1A ENDOLEAK. POST RE-INTERVENTION THE PATIENT WAS IDENTIFIED TO HAVE AN ADDITIONAL ENDOLEAK AT AN UNDETERMINED ORIGIN. PATIENT EXPIRED ONE DAY POST RE-INTERVENTION.

  Patient problems: Aneurysm; Blood Loss; Death; Failure of Implant; Rupture; Stenosis

  MAUDE report 10861626 ↗
• InjuryJul 27, 2020Migration; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY, SIX YEARS POST INITIAL PROCEDURE, ROUTINE FOLLOW-UP COMPUTERIZED TOMOGRAPHY IDENTIFIED ANEURYSM ENLARGEMENT OF 8CM AND ~20MM MIGRATION OF THE VELA SUPRARENAL. REPORTEDLY, THE LUMBER AND INFERIOR MESENTERIC ARTERIES ARE PATENT. THE PATIENT IS BEING MONITORED. RE-INTERVENTION HAS NOT YET BEEN SCHEDULED. ADDITIONAL INFORMATION: DURING CLINICAL ASSESSMENT, IT WAS DETERMINED THAT THE PATIENT UNDERWENT A SECONDARY PROCEDURE AND WAS DISCHARGED ON (B)(6) 2020 POST PROCEDURE (DATE OF ACTUAL PROCEDURE UNKNOWN) UPON REVIEWING THE PATIENT'S DISCHARGE SUMMARY REPORT.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 10330643 ↗
• InjuryApr 17, 2019Migration or Expulsion of Device; Off-Label Use; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Insufficient Device Problem Information; Migration or Expulsion of Device; Off-Label Use; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A STENT GRAFT EXTENSION AND AN INFRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, A TYPE 1A ENDOLEAK WAS IDENTIFIED (EXACT DATE OF EVENT IS UNKNOWN). IT WAS REPORTED THAT AN INTERVENTION WAS COMPLETED WITH AN NON- ENDOLOGIX STENT (MEDTRONIC). NO FURTHER INFORMATION WAS PROVIDED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8525447 ↗
• InjuryJan 3, 2019Unintended Movement; Unintended Movement

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 4.5 YEARS POST INITIAL PROCEDURE, THE SUPRARENAL STENT GRAFT EXTENSION HAS MIGRATED / MOVED BUT NO ENDOLEAK IS CURRENTLY PRESENT. A SECONDARY PROCEDURE WAS COMPLETED AS A PRECAUTIONARY MEASURE. THE PHYSICIAN ELECTED TO IMPLANTED AN ADDITIONAL INFRARENAL STENT GRAFT EXTENSION TO TREAT THE REPORTED EVENT. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8215570 ↗
• InjuryDec 10, 2018Loss of or Failure to Bond; Leak/Splash; Unintended Movement; Loss of or Failure to Bond; Leak/Splash; Unintended Movement

  THE PATIENT WAS INITIALLY TREATED WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT. DURING THE PROCEDURE, THE 25 VELA MOVED DOWNWARDS (IMPLANT MOVEMENT) WHICH CAUSED A TYPE IIIA ENDOLEAK (SEPARATION BETWEEN THE MAIN BODY AND CUFF). IN RESPONSE THE PHYSICIAN IMPLANTED A 28 VELA (5MM PROXIMAL TO 25 VELA) TO ENSURE A SEALED NECK; A PALMAZ (NON-ENDOLOGIX) STENT WAS ALSO IMPLANTED TO RESOLVE THE LEAK. HOWEVER, TWO (2) DAYS AFTER THE INDEX PROCEDURE WAS COMPLETED, A FOLLOW-UP CT WAS PERFORMED WHICH CONFIRMED THAT THE INTRAOPERATIVE ENDOLEAK HAS PERSISTED. THE PHYSICIAN PLANS TO RE-INTERVENE AND WILL CONTINUE TO MONITOR THE PATIENT. IT IS UNKNOWN IF THE PATIENT IS SYMPTOMATIC. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8148768 ↗
• InjuryOct 27, 2017Malposition of Device; Unintended Movement; Malposition of Device; Unintended Movement

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT, AN INFRARENAL AORTIC EXTENSION, AND A SUPRARENAL AORTIC EXTENSION. ON (B)(6) 2017 IT WAS REPORTED THE PATIENT HAD A RENAL ARTERY OCCLUSION DUE TO POSSIBLE STENT MOVEMENT. A SECONDARY INTERVENTION HAS NOT BEEN REPORTED. THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Occlusion; Renal Failure; Stenosis

  MAUDE report 6985490 ↗

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-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-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-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-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-0590-06 · 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-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• 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-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.