Class II — Maquet Cardiovascular Us Sales, 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 | Terminated |
| Reason | A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console. |
| Product | Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console. |
| Quantity | 11 distributed in the US |
| Distribution | The products were distributed to the following US states: ME, NV, NY, OH, PA, TX, and VA. |
| Initiated | 2019-12-03 |
| Classified | 2019-12-12 |
| Terminated | 2020-09-18 |
| Recall number | Z-0678-2020 |
| 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 Us Sales, Llc (Z-0678-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84377/
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