FDA Device recall Z-1317-2024
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090
- FDA Device
- Class II
- ongoing
- Published 2024-03-27
On 2024-03-27 the FDA classified a Class II recall of Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090 by Medtronic, citing there is a potential for sterile package breach.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1317-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-16 |
| Published | 2024-03-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic |
| Distribution | US |
Product
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Reason
There is a potential for sterile package breach.
Identifiers
| code_info | a) AB9U14080090, UDI/DI 00643169796294, Batch Number B456626; b) AB9U18100090, UDI/DI 00643169796409, Batch Number B45…a) AB9U14080090, UDI/DI 00643169796294, Batch Number B456626; b) AB9U18100090, UDI/DI 00643169796409, Batch Number B456811; c) AB9G14100090, IUDI/DI 00763000547325, Batch Number B460542 |
|---|
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-1317-2024%22
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