Cardiohelp-I System Product Usage: A blood oxygenation and carbon… — Class II medical device recall Z-0211-2015
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2014-11-19, distributed nationwide. Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a "
| Recall number | Z-0211-2015 |
|---|---|
| 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 | 2014-10-17 |
| Classified | 2014-11-13 |
| Reported by FDA | 2014-11-19 |
| Terminated | 2016-04-06 |
| Distributed | Nationwide (US) |
| Quantity | 331 units |
| Reason classes | software |
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).
Reason for recall
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
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-0211-2015. 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.