Class II — Maquet Cardiovascular, LLC
| Recalling firm | Maquet Cardiovascular LLC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The Positioner Arm may not tighten or lock during normal use. |
| Product | Acrobat-i Vacuum Positioner System, Model Number XP-5000Z |
| Quantity | 6472 units |
| Distribution | US Nationwide. Global Distribution. |
| Initiated | 2023-10-31 |
| Classified | 2023-12-19 |
| Recall number | Z-0589-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Maquet Cardiovascular, LLC (Z-0589-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93477/
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