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 | Terminated |
| Reason | The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling. |
| Product | Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. |
| Quantity | 28 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the state of Florida and the countries of South Korea and Poland. |
| Initiated | 2021-08-25 |
| Classified | 2021-09-29 |
| Terminated | 2024-04-10 |
| Recall number | Z-2589-2021 |
| 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-2589-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88606/
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