FDA Device recall Z-0211-2015
Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal byp…
- FDA Device
- Class II
- terminated
- Published 2014-11-19
On 2014-11-19 the FDA classified a Class II recall of Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal byp… by Maquet Cardiovascular Us Sales, citing 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 u….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0211-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-17 |
| Published | 2014-11-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Maquet Cardiovascular Us Sales |
| Distribution | US |
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
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
Identifiers
| code_info | 90410803 90410984 90410456 90410609 90410610 90410740 90410737 90410738 90410733 90410865 90411005 90410552…90410803 90410984 90410456 90410609 90410610 90410740 90410737 90410738 90410733 90410865 90411005 90410552 90410572 90410849 90410864 90410867 90410796 90410481 90410319 90410328 90411176 90410988 90410703 90410431 90411186 90411188 90411191 90410800 90410611 90410669 90410517 90410692 90410499 90410500 90410739 90410612 90410714 90410759 90410771 90410430 90410276 90410576 90410482 90410749 90410774 90410859 90410860 90410863 90411088 90411082 90411087 90411091 90411089 90410866 90411144 90410970 90411023 90411033 90411038 90411032 90410974 90410962 90410455 90410448 90410449 90411175 90410524 90411007 90410353 90410433 90410435 90410770 90410785 90410440 90410932 90410968 90410732 90411035 90411028 90410736 90410249 90410410 90410411 90411169 90411157 90410963 90411078 90410237 90410284 90410786 90410772 90410922 90411093 90411192 90411193 90410582 90410516 90410662 90410666 90410664 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0211-2015%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.