Abiomed, Inc. is recalling 4,966 Impella RP heart pump devices because the differential pressure (dP) sensor may malfunction, causing sensor values to drift. This sensor drift can lead to inaccurate monitoring and potential device management issues during use. The recall affects several models including the Impella RP, Impella RP with SmartAssist, and Impella RP Flex with SmartAssist distributed worldwide.
A malfunctioning pressure sensor can provide inaccurate readings of the patient's heart pressure, which may lead to inappropriate clinical decisions or device adjustments. If the sensor values drift significantly, it could potentially impact the quality of cardiac support provided to the patient.
Recall #: Z-1469-2026; Quantity: 291 units
Recall #: Z-1470-2026; Quantity: 4,496 units
Recall #: Z-1471-2026; Quantity: 179 units; Distributed outside the US.
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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