Atrium ADVANTA VXT Vascular Graft — Class II medical device recall Z-2589-2021
Terminated recall by Atrium Medical Corporation, reported 2021-10-06, distributed nationwide. The product package may potentially contain a mismatched graft that does not contain the radial support ring (
| Recall number | Z-2589-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atrium Medical Corporation, Merrimack, NH, United States |
| Recall initiated | 2021-08-25 |
| Classified | 2021-09-29 |
| Reported by FDA | 2021-10-06 |
| Terminated | 2024-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | KR, PL |
| Quantity | 28 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00650862220599 |
| Lot numbers | 458755 |
| Serial numbers | 458755001, 458755002, 458755003, 458755004, 458755005, 458755006, 458755007, 458755008, 458755009, 458755010, 458755011, 458755012, 458755013, 458755014, 458755015, 458755016, 458755017, 458755018, 458755019, 458755020, 458755021, 458755022, 458755023, 458755024, 458755025 and 5 more |
| Model numbers | 22059 |
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.
Reason for recall
The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.
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-2589-2021. 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.