FDA Device recall Z-0678-2020
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161
- FDA Device
- Class II
- terminated
- Published 2019-12-18
On 2019-12-18 the FDA classified a Class II recall of Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161 by Maquet Cardiovascular Us Sales, citing A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0678-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-03 |
| Published | 2019-12-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Maquet Cardiovascular Us Sales |
| Distribution | ME, NV, NY, OH, PA, TX, VA |
Product
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
Reason
A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.
Identifiers
| code_info | UDI: 04037691258997; Serial Numbers 9348936 910114412 910114420 910114429 910114430 910114432 910114435 910114438 910117243 91064722 91067680 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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All Maquet Cardiovascular Us Sales recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0678-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.