Maquet Cardiohelp Emergency Drive Recalled for Gearwheel Assembly Defect
Maquet Cardiovascular is recalling 10 units of the Cardiohelp Emergency Drive because the gearwheel may have been incorrectly reassembled, leading to inadequate operation.
What this means for you
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 I, which is typically unlikely to cause adverse health consequences. The defect involves a mechanical assembly error that may lead to inadequate operation, but no injuries or illnesses are reported in the source text.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling 10 units of the Cardiohelp Emergency Drive, Part No. 70104.8002. The recall is due to a potential defect where the gearwheel may have been incorrectly reassembled during servicing, which could lead to inadequate operation of the device.
The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails. The affected units were distributed nationwide in the states of California, Florida, Illinois, Kentucky, Michigan, and New York. The specific affected serial numbers are: 90420359, 90421204, 90421188, 90421279, 90421228, 90421761, 90420904, 90420231, 90420455, and 90421304.
Healthcare facilities and users should check their inventory for these specific serial numbers. If the device is found, it should be removed from service and returned to Maquet Cardiovascular US Sales, LLC in accordance with the recall instructions.
The recalled product
- Product
- Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Category
- Medical Device — Cardiovascular
- Affected units
- 10
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 (10)
- Affected serial numbers: 90420359
- 90421204
- 90421188
- 90421279
- 90421228
- 90421761
- 90420904
- 90420231
- 90420455
- 90421304
Distribution
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