FLIXENE — Class II medical device recall Z-2017-2024
Ongoing recall by Atrium Medical Corporation, reported 2024-06-12, distributed nationwide. Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap betwe
| Recall number | Z-2017-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atrium Medical Corporation, Merrimack, NH, United States |
| Recall initiated | 2024-05-03 |
| Classified | 2024-06-04 |
| Reported by FDA | 2024-06-12 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00650862251388 |
Product
FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
Reason for recall
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
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-2017-2024. 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.