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The U.S. Food and Drug Administration (FDA) is aware that Abiomed has issued an Urgent Medical Device Correction to notify affected customers of updated use instructions for all Impella RP with SmartAssist and Impella RP Flex with SmartAssist devices. Abiomed has identified that the differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift over time. If sensor drift occurs, the Automated Impella Controller (AIC) may display inaccurate information, including pump flow readings, Pulmonary Artery (PA) Placement Signal, Pulmonary Artery Pulsatility Index (PAPi), and Central Venous (CV) Placement Signal.
As of January 15, Abiomed has reported 22 injuries and no deaths associated with this issue.
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Abiomed, Inc. at onemed-field-actions@its.jnj.com.
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