Abiomed, Inc. is recalling approximately 3,924 Impella RP and Impella RP Flex heart pumps with SmartAssist. These medical devices are being recalled because the optical sensors can be damaged if they physically interact with other medical equipment, such as guidewires or indwelling central venous lines, during insertion, placement, or removal. This damage can result in the heart pump providing unreliable placement signals or stopping entirely, which may cause a sudden loss of circulatory support for the patient.
Sensor damage can lead to a temporary or permanent pump stop, which poses a critical risk to patients relying on the device for heart support. While specific injury counts were not provided in the alert, the agency has classified the failure risk as critical due to the potential for severe health consequences if mechanical support is lost.
Corrective Action
Recall Number: Z-0829-2025; Affects 1,560 units.
Recall Number: Z-0830-2025; Affects 2,364 units.
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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