FDA Device recall Z-0464-2022
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System
- FDA Device
- Class II
- terminated
- Published 2022-01-12
On 2022-01-12 the FDA classified a Class II recall of Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing there have been reports of stent migration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0464-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-19 |
| Published | 2022-01-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | US |
Product
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
Reason
There have been reports of stent migration.
Identifiers
| code_info | The IFU for all model numbers and serial numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0464-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.