Drug recall
Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the…
FDA recall event 93195 · Class II · Atrium Medical Corporation
Key facts
| Event ID | 93195 |
|---|---|
| Recall numbers | Z-0291-2024 |
| Recalling firm | Atrium Medical Corporation |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment. |
| Initiation date | Sep 21, 2023 |
| Report date | Nov 22, 2023 |
| City | Merrimack |
| State | NH |
| Country | United States |
| FEI number | 3011175548 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: