FDA Device recall Z-0485-2025
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
- FDA Device
- Class II
- ongoing
- Published 2024-11-27
On 2024-11-27 the FDA classified a Class II recall of Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z by Maquet Cardiovascular, citing deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0485-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-16 |
| Published | 2024-11-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Maquet Cardiovascular |
| Distribution | US |
Product
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
Reason
Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
Identifiers
| code_info | Model Number C-OM-9000Z. UDI-DI Number: 00607567900004. Batch Numbers: 3000270477, 3000274130, 3000279333, 3000325028,…Model Number C-OM-9000Z. UDI-DI Number: 00607567900004. Batch Numbers: 3000270477, 3000274130, 3000279333, 3000325028, 3000349295, 3000356305, 3000368568, 3000288446, 3000314841, 3000318197, 3000340989, 3000315179, 3000284660, 3000279342, 3000325025, 3000340964, 3000274640, 3000280059, 3000280563, 3000325362, 3000284695, 3000314838, 3000349055, 3000356063, 3000298982, 3000317739, 3000376711, 3000279839, 3000399170, 3000362853, 3000337154, 3000321412, 3000299814, 3000288445, 3000269996. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0485-2025%22
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