FDA Device recall Z-0291-2024
Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal a…
- FDA Device
- Class II
- ongoing
- Published 2023-11-22
On 2023-11-22 the FDA classified a Class II recall of Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal a… by Atrium Medical, citing balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0291-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-21 |
| Published | 2023-11-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Atrium Medical |
| Distribution | n/a |
Product
Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 covered stent sizes. In Canada, the Advanta V12 Covered Stent indication excludes renal arteries. REF: 85361
Reason
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
Identifiers
| code_info | UDI-DI: 00650862853612 Lot Numbers: 464909, 464910 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0291-2024%22
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