Maquet VH-3010 Power Supply Recalled for Inadequate Heating Function
Maquet Cardiovascular is recalling 110 units of the VH-3010 Power Supply due to an incorrect resistor that may prevent the HemoPro 2 harvesting tool jaws from heating adequately.
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: This is an FDA Class II recall (per agency classification), which places it at severity 2-4. The source text reports no illnesses, injuries, or hospitalization reports and indicates only a theoretical risk that the jaws may not adequately heat, making this a precautionary recall without documented harm. This matches the Moderate (score 2) criterion for minor functional defects without reported adverse events.
Plain-English summary
Maquet Cardiovascular, LLC is recalling 110 units of the Maquet VH-3010 Power Supply, a component that delivers power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2). The recall is due to an incorrect resistor in the power supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.
The affected units were distributed worldwide, including US nationwide distribution across Alabama, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Texas, Utah, Virginia, Wisconsin, West Virginia, and internationally in China, Japan, Netherlands, New Zealand, Singapore, and the United Kingdom. Specific serial numbers are listed in the FDA recall notice.
Affected users should stop using the recalled power supplies and contact Maquet Cardiovascular, LLC for guidance on replacement or service options. The FDA has classified this as a Class II recall. Healthcare facilities and users of the HemoPro 2 system should verify serial numbers against the official recall notice to determine if their units are affected.
The recalled product
- Product
- Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).
- Manufacturer
- Maquet Cardiovascular, LLC
- Hazard
- Affected units
- 110
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No. VH-3010
- UDI-DI: 0060756770826
- Serial No. H24080065G
- H24080074G
- H24080012G
- H24080022G
- H24080184G
- H24080185G
- H24080051G
- H24080117G
- H24080069G
- H24080016G
- H24080079G
- H24080041G
- H24080056G
- H24080030G
- H24080068G
- H24080034G
- H24080058G
- H24080026G
Distribution
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