Approximately 91,914 Impella heart pumps, which are intravascular blood pumps used to support the circulatory system, are being recalled because the Instructions for Use (IFU) did not adequately warn about the risk of the pump inlet perforating the wall of the heart's left ventricle. This issue occurs due to operator handling during the insertion and use of the device, which can lead to serious internal injury or death. These medical devices were distributed worldwide between 2021 and 2024 and are used in hospital settings for patients requiring cardiac support.
If the device is handled incorrectly by a medical operator, the pump tip can puncture or perforate the wall of the left ventricle. This can cause severe internal bleeding, cardiac tamponade, and other life-threatening complications for the patient.
IFU Update and Technical Instruction
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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