Atrium Advanta V12 Covered Stent System — Class II medical device recall Z-0291-2024
Ongoing recall by Atrium Medical Corporation, reported 2023-11-22. Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
| Recall number | Z-0291-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atrium Medical Corporation, Merrimack, NH, United States |
| Recall initiated | 2023-09-21 |
| Classified | 2023-11-10 |
| Reported by FDA | 2023-11-22 |
| Countries outside the US | AU, BE, CA, DE, FR, GB, GR, MT, NL, NZ, PT |
| Quantity | 141 units |
| UPC / GTIN / UDI-DI | 00650862853612 |
| Lot numbers | 464909, 464910 |
| Model numbers | 85361 |
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 for recall
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0291-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.