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iCast covered stent system, 12mm x 29mm x 80cm GBX12291A

by Atrium Medical Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00650862122916 UDI-DI Date18 Feb 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0291-2024 FDA Class II initiated 21 Sep 2023

    Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
iCast covered stent system, 12mm x 29mm x 80cm
Generic Name
Peripheral artery endovascular stent-graft, non-medicated
Model / Reference
GBX12291A
Primary DI / UDI-DI
00650862122916
PMA Number
FDA Product Code
PRL
GMDN Term
Peripheral artery endovascular stent-graft, non-medicated
Device Class
Class III
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Stent Diameter — 12 Millimeter
Stent Length — 29 Millimeter
Catheter Length — 80 Centimeter

Related devices

Cleared under the same submission (P120003)

Show all (12)

Other devices from Atrium Medical Corporation

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (7)

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