Maquet Cardiopulmonary — Class II medical device recall Z-0678-2020
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2019-12-18, distributed in ME, NV, NY, OH, PA, TX, VA. A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.
| Recall number | Z-0678-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc, Wayne, NJ, United States |
| Recall initiated | 2019-12-03 |
| Classified | 2019-12-12 |
| Reported by FDA | 2019-12-18 |
| Terminated | 2020-09-18 |
| Distributed | ME, NV, NY, OH, PA, TX, VA |
| Quantity | 11 distributed |
| UPC / GTIN / UDI-DI | 04037691258997 |
| Serial numbers | 910114412, 910114420, 910114429, 910114430, 910114432, 910114435, 910114438, 910117243, 91064722, 91067680, 9348936 |
| Model numbers | 701022161 |
Product
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
Reason for recall
A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0678-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.