Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood…
Medical device recall Z-0211-2015. Published in FDA’s Enforcement Report on Nov 19, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 19, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 331 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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).
331 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,998 characters
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 90410665 90410235 90411189 90411187 90411154 90411179 90411178 90410580 90410596 90410599 90410651 90410646 90410735 90410787 90410839 90410851 90410848 90410852 90410845 90411105 90411143 90411145 90411141 90410530 90410584 90410607 90410575 90410581 90410498 90410756 90410936 90410663 90410909 90410746 90410744 90410450 90410606 90410979 90411004 90411009 90411006 90411010 90410398 90410400 90410399 90410713 90410973 90410351 90410352 90410840 90410242 90410252 90410239 90410426 90410427 90410754 90410503 90410518 90411008 90410573 90410577 90410585 90410668 90410408 90410409 90410653 90410961 90410982 90411174 90410568 90410406 90410640 90410644 90410534 90410537 90410780 90411146 90411181 90411184 90411108 90411107 90411171 90410986 90411003 90410716 90410638 90410717 90411036 90411037 90410847 90410231 90410458 90410779 90410783 90411168 90411170 90410975 90410782 90410846 90410838 90410650 90410608 90410844 90410745 90410980 90410777 90410930 90410278 90410355 90410389 90410989 90410277 90410520 90410964 90410734 90410929 90410927 90410832 90410595 90410532 90410535 90410529…
FDA’s list runs to 2,978 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US Nationwide
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 17, 2014.
- FDA classified it on Nov 13, 2014.
- FDA’s Enforcement Report published it on Nov 19, 2014.
- FDA terminated it on Apr 6, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Maquet Cardiovascular Us Sales, Llc, of Wayne, NJ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,978 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.