Class II — Atrium Medical Corporation
| Recalling firm | ATRIUM MEDICAL CORPORATION |
|---|---|
| Registered facility | Atrium Medical Corporation (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label. |
| Product | iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616 |
| Quantity | 11 devices |
| Distribution | US Nationwide distribution in the states of FL, MA, MI, OH, WA. |
| Initiated | 2024-09-09 |
| Classified | 2024-10-07 |
| Recall number | Z-0024-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Atrium Medical Corporation (Z-0024-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95329/
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