FDA Device recall Z-0983-2019
AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibili…
- FDA Device
- Class II
- terminated
- Published 2019-03-13
On 2019-03-13 the FDA classified a Class II recall of AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibili… by Maquet Cardiovascular, citing potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0983-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-24 |
| Published | 2019-03-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Maquet Cardiovascular |
| Distribution | US |
Product
AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility
Reason
Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).
Identifiers
| code_info | Lot Numbers: 96255605,96255607,96255608,96255609,96255611 UDI: 20607567700745 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0983-2019%22
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