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

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00818009013507), received between Jun 26, 2020 and Jan 9, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Off-Label Use” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2026Deformation Due to Compressive Stress

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AN AFX VELA SUPRARENAL AND TWO OVATION IX ILIAC LIMBS ON (B)(6) 2025. THE FOLLOWING DAY A FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE VELA INFRARENAL WAS BENT OVER FROM THE ANGLE IN THE PATIENT¿S NECK AND CAUSING A STENOSIS. INTERVENTION OCCURRED ON (B)(6) 2025 WITH IMPLANTATION OF VELA INFRARENAL AND VELA SUPRARENAL. STENOSIS WAS FIXED AND PATIENT IS OUT OF HE HOSPITAL.

  Patient problems: Stenosis

  MAUDE report 24030667 ↗
• InjuryDec 12, 2025Off-Label Use; Material Puncture/Hole; Lack of Effect; Off-Label Use; Material Puncture/Hole; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2016 WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL. ON (B)(6) 2025 THE PATIENT PRESENTED EMERGENTLY IN PAIN. A COMPUTED TOMOGRAPHY (CT) SCAN WAS TAKEN AND A TYPE IIIB ENDOLEAK IN THE AFX VELA INFRARENAL WAS OBSERVED. THE PHYSICIAN ELECTED TO RELINE WITH A NEW AFX VELA SUPRARENAL. THE ENDOLEAK WAS RESOLVED AND THE PATIENT¿S FINAL STATUS WAS REPORTED AS OKAY.

  Patient problems: Clinical Endoleak; Pain

  MAUDE report 23790594 ↗
• InjuryMay 14, 2024Collapse; Collapse

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL AORTIC EXTENSION ON (B)(6) 2023. APPROXIMATELY SIX (6) MONTHS POST INITIAL PROCEDURE, A NON-CONTRAST CT (COMPUTED TOMOGRAPHY) IMAGES SHOWED THE VELA AORTIC EXTENSION WAS PARTIALLY COLLAPSED AND BLOOD TO THE LOWER LIMB APPEARED TO BE LIMITED. CONTRAST CT IMAGES WERE TAKEN AND THE VELA THROMBOLIZATION WAS CONFIRMED. THEY PHYSICIAN THEN ELECTED TO EXPLANT BOTH AFX2 AND VELA DEVICES AND PERFORMED VESSEL REPLACEMENT. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19310878 ↗
• InjuryDec 28, 2023Off-Label Use; Device-Device Incompatibility; Off-Label Use; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) AND RIGHT COMMON ILIAC ARTERY ANEURYSM (CIAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL PROXIMAL EXTENSION. IT WAS REPORTED THAT PRIOR TO THE AFX DEVICE IMPLANT THE RIGHT INTERNAL ILIAC ARTERY WAS OCCLUDED FOLLOWED BY IMPLANT OF A GORE (NON-ENDOLOGIX) EXCLUDER ON THE RIGHT SIDE, AND AN ENDURANT (NON-ENDOLOGIX) ILIAC LIMB ON THE LEFT SIDE. A VIABAHN (NON-ENDOLOGIX) STENT WAS THEN IMPLANTED IN THE RIGHT RENAL ARTERY BECAUSE THERE WAS A PRE-EXISTING DISSECTION AT THE ORIGIN OF RENAL ARTERY. 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. THE AFX2 WAS THEN IMPLANTED FOLLOWED BY THE AFX VELA WHICH WAS POSITIONED BELOW THE RENAL ARTERY. AN ANGIOGRAM WAS PERFORMED AND SHOWED TYPE 3A ENDOLEAK BETWEEN THE AFX2 AND THE ENDURANT WHICH REQUIRED AN AFX LIMB TO BE IMPLANTED. THE ENDOLEAK WAS RESOLVED AND THE PROCEDURE WAS COMPLETED. NOW, APPROXIMATELY FIVE AND A HALF (5.5) YEARS POST INITIAL PROCEDURE, AN OPEN SURGICAL PROCEDURE WAS PERFORMED DUE TO SAC ENLARGEMENT AND A TYPE 1A ENDOLEAK. THE

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 18410202 ↗
• InjuryMar 10, 2022Off-Label Use; Difficult to Remove; Off-Label Use; Difficult to Remove

  REPORTEDLY, THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AN AFX VELA INFRARENAL. AFTER THE AFX VELA INFRARENAL WAS DEPLOYED THE TIP BECAME STUCK WHEN THE PHYSICIAN INTENDED TO RETRACT IT INTO THE SHEATH. ALTHOUGH THE AFX VELA INFRARENAL DELIVERY SYSTEM DID NOT APPEAR TO BE STUCK IN THE STENT, IT WAS UNABLE TO BE WITHDRAWN DESPITE MULTIPLE ATTEMPTS. THEREFORE, THE DELIVERY SYSTEM AND THE SHEATH WERE REMOVED TOGETHER. OUTSIDE OF THE BODY, IT WAS FOUND THAT THE SHEATH SHAFT HAD AN ACCORDION-LIKE DEFORMATION. A NON-ENDOLOGIX BARE STENT (8MM X 8CM) WAS DEPLOYED IN THE LEFT EXTERNAL ILIAC ARTERY AS A DISSECTION OCCURRED IN THE INTIMA BY THE GAP BETWEEN THE SHEATH AND THE TIP OF VELA SUPRARENAL DELIVERY SYSTEM. THE SHEATH WAS REPLACED WITH DRYSEAL (NON-ENDOLOGIX) AND THE PROCEDURE CONTINUED. THE FINAL PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 13721611 ↗
• InjuryJan 19, 2021Insufficient 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 (AAA) ON AN UNKNOWN DATE. RECENTLY, A TYPE 3A ENDOLEAK WITH SEPARATION WAS IDENTIFIED. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN INFRARENAL STENT GRAFT AND AN LIMB STENT GRAFT. THIS WAS REPORTED UNDER MRN# 2031527-2021-00017. ARTERY LACERATION WAS REPORTED DURING THE SECONDARY ENDOVASCULAR PROCEDURE AND UPON REMOVAL OF THE INTRODUCER SHEATH. THE PHYSICIAN DISSECTED THE REGION, SUTURED THE DAMAGED AREA, AND INFUSED BLOOD. THE PATIENT REPORTEDLY RECOVERED WELL AND WAS TRANSFERRED TO ICU (INTENSIVE CARE UNIT). THE PATIENT IS REPORTEDLY IN GOOD CONDITION BESIDES AN UNRELATED HEART ATTACK.

  Patient problems: Perforation of Vessels

  MAUDE report 11198050 ↗
• InjuryJun 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AFX BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION AND A LIMB STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST SECONDARY PROCEDURE, DURING A ROUTINE FOLLOW UP, A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IDENTIFIED A TYPE 3A ENDOLEAK WITH SEPARATION BETWEEN THE LIMB EXTENSION AND BIFURCATED STENT GRAFT AND ANEURYSM GROWTH. THE PHYSICIAN ELECTED TO IMPLANT AN AFX LIMB STENT GRAFT AND AN OVATION IX ILIAC LIMB EXTENSION TO RESOLVED THIS EVENT. THE PATIENT WAS REPORTED AS DOING WELL. NOTE: THIS PATIENT HAD A PREVIOUSLY REPORTED EVENT UNDER MFR #2031527-2018-00279 FOR A TYPE 3A ENDOLEAK. A VELA INFRARENAL STENT GRAFT WAS IMPLANTED TO TREAT THIS EVENT.

  Patient problems: Failure of Implant

  MAUDE report 10201121 ↗

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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-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-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• 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-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• 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-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

…and 1 more.