Abiomed, Inc. is recalling nine Impella CP with SmartAssist heart pumps because they failed a quality inspection but were accidentally shipped and released for use. These specific pumps are used to provide temporary support to the left side of the heart during high-risk medical procedures. Consumers and healthcare facilities in Florida, Massachusetts, Ohio, and Texas should check their inventory for the nine specific serial numbers affected by this error. Because these units did not pass inspection, they may not function as intended during critical cardiac support.
The use of a heart pump that has failed quality inspections poses a significant risk of device malfunction or failure during use. This could lead to a sudden loss of circulatory support for patients who are already in critical condition, potentially resulting in serious health complications or death.
Manufacturer notification and device return
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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