FDA Device recall Z-2009-2024
FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
- FDA Device
- Class II
- ongoing
- Published 2024-06-12
On 2024-06-12 the FDA classified a Class II recall of FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft by Atrium Medical, citing complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2009-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-03 |
| Published | 2024-06-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Atrium Medical |
| Distribution | US |
Product
FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
Reason
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Identifiers
| code_info | Product Code: 25052; UDI-DI: 00650862250527. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2009-2024%22
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