FDA Device recall Z-2274-2023
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000
- FDA Device
- Class II
- ongoing
- Published 2023-08-09
On 2023-08-09 the FDA classified a Class II recall of ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000 by Maquet Cardiovascular, citing the Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and posit….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2274-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-28 |
| Published | 2023-08-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Maquet Cardiovascular |
| Distribution | US |
Product
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
Reason
The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.
Identifiers
| code_info | UDI-DI: 00607567700581 |
|---|
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-2274-2023%22
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