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 | Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a "Battery Needs Service" message after startup of the units when using either AC or DC power |
| Product | Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours). |
| Quantity | 331 units |
| Distribution | Worldwide Distribution - US Nationwide |
| Initiated | 2014-10-17 |
| Classified | 2014-11-13 |
| Terminated | 2016-04-06 |
| Recall number | Z-0211-2015 |
| 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-0211-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69557/
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