Maquet Cardiohelp-I System Recalled for Potential Software Display Error
Maquet Cardiovascular is recalling 331 Cardiohelp-I Systems due to a software issue that may display an erroneous 'Battery Needs Service' message after startup.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a software display error that does not explicitly report injuries, deaths, or hospitalizations, fitting the criteria for a moderate severity recall involving a potential defect without reported harm.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling 331 units of the Cardiohelp-I System. This device is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass, or for procedures not requiring cardiopulmonary bypass, for periods up to six hours.
The recall is due to a software issue that can potentially result in an erroneous display of a "Battery Needs Service" message after the startup of the units when using either AC or DC power. The affected units were distributed worldwide and nationwide in the United States.
Hospitals and healthcare facilities should contact Maquet Cardiovascular for instructions on how to address the software issue. The source text does not specify a consumer action for individual patients, as the device is used in clinical settings.
The recalled product
- 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).…
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Affected units
- 331
Distribution
Distributed nationwide across the United States.
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