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 | Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissue or vasculature, or a coronary artery or previously placed bypass graft, or could result in procedural delay and/or conversion. |
| Product | Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z |
| Quantity | 2951 units |
| Distribution | Nationwide Foreign: AT BE DE ES FR GB IT JP KR LU NL PL PT TR |
| Initiated | 2023-09-13 |
| Classified | 2023-10-22 |
| Recall number | Z-0137-2024 |
| 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-0137-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93085/
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