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Vela Proximal Endograft System A28-28/C95 V

by Endologix LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

16 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00818009013521 UDI-DI Date24 Sep 2014ListedStatusListed GUDID: in commercial distribution

Recalls

16 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1049-2017 FDA Class II initiated 4 Jan 2017
    • Terminated Z-1048-2017 FDA Class II initiated 4 Jan 2017

    Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.

    • Terminated Z-1035-2017 FDA Class II initiated 27 Dec 2016

    Endologix initiated a correction by updating reports for the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System).

  • 5 recalls, same reason

    • Terminated Z-1038-2017 FDA Class II initiated 27 Dec 2016
    • Terminated Z-1047-2017 FDA Class II initiated 27 Dec 2016
    • Terminated Z-1037-2017 FDA Class II initiated 27 Dec 2016
    • Terminated Z-1039-2017 FDA Class II initiated 27 Dec 2016
    • Terminated Z-1054-2017 FDA Class II initiated 27 Dec 2016

    Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).

  • 8 recalls, same reason

    • Terminated Z-0595-06 FDA Unclassified (pre-2012) initiated 14 Dec 2005
    • Terminated Z-0593-06 FDA Unclassified (pre-2012) initiated 14 Dec 2005
    • Terminated Z-0591-06 FDA Unclassified (pre-2012) initiated 14 Dec 2005
    • Terminated Z-0590-06 FDA Unclassified (pre-2012) initiated 14 Dec 2005
    • Terminated Z-0592-06 FDA Unclassified (pre-2012) initiated 14 Dec 2005
    • Terminated Z-0596-06 FDA Unclassified (pre-2012) initiated 14 Dec 2005
    • Terminated Z-0589-06 FDA Unclassified (pre-2012) initiated 14 Dec 2005
    • Terminated Z-0594-06 FDA Unclassified (pre-2012) initiated 14 Dec 2005

    The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Vela Proximal Endograft System
Generic Name
Aortoiliac endovascular stent-graft
Model / Reference
A28-28/C95 V
Primary DI / UDI-DI
00818009013521
PMA Number
FDA Product Code
MIH
GMDN Term
Aortoiliac endovascular stent-graft
Device Class
Class III
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Category: Aortoiliac endovascular stent-graft

Cleared under the same submission (P040002)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Serial Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Manufacturing Date: No