Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 19, 2014
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).
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Maquet Cardiovascular Us Sales, Llc recalled Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal sy… - a moderate-severity action.
Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal sy… was recalled by Maquet Cardiovascular Us Sales, Llc in November 19, 2014. Reason: Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a "…. Check the official notice for the remedy. Verify recall #Z-0211-2015 with the FDA Devices before acting.
The recall
Maquet Cardiovascular Us Sales, Llc issued this moderate-severity FDA Devices recall-Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a "….
- Moderate
- severity level
- 331 units
- affected scope
- Class II
- classification
- November 19, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0211-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0211-2015) was formally reported on November 19, 2014, with the manufacturer initiating the action on October 17, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Maquet Cardiovascular Us Sales, Llc is listed as the recalling firm, operating out of Wayne, NJ. Federal records list the affected scope as 331 units.
The documented reason for this recall is: 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 Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
331 units
Related Recalls
6
3 from same agency
Product description
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0211-2015 |
| Date reported | November 19, 2014 |
| Date initiated | October 17, 2014 |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc |
| Firm location | Wayne, NJ |
| Affected scope | 331 units |
| Distribution | Worldwide Distribution - US Nationwide |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0211-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was 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).. Recalled by Maquet Cardiovascular Us Sales, Llc. Units affected: 331 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 19, 2014. Severity: Moderate. Recall number: Z-0211-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0211-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 19, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.