FDA Device recall Z-0589-2024
Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
- FDA Device
- Class II
- ongoing
- Published 2023-12-27
On 2023-12-27 the FDA classified a Class II recall of Acrobat-i Vacuum Positioner System, Model Number XP-5000Z by Maquet Cardiovascular, citing the Positioner Arm may not tighten or lock during normal use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0589-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-31 |
| Published | 2023-12-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Maquet Cardiovascular |
| Distribution | US |
Product
Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
Reason
The Positioner Arm may not tighten or lock during normal use.
Identifiers
| code_info | UDI-DI: 00607567500006; Lot Numbers: 3000195267, 3000195268, 3000195273, 3000195663, 3000199248, 3000199725, 3000204637…UDI-DI: 00607567500006; Lot Numbers: 3000195267, 3000195268, 3000195273, 3000195663, 3000199248, 3000199725, 3000204637, 3000207240, 3000211594, 3000212053, 3000213219, 3000214053, 3000214054, 3000214255, 3000221064, 3000214052, 3000225770, 3000226531, 3000225866, 3000225769, 3000231209, 3000231210 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0589-2024%22
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