FDA Update: Agency Announces Abiomed Recall of Labeling For Impella RP Flex With SmartAssist
The U.S. Food and Drug Administration (FDA) announced on Aug. 17 that Abiomed is recalling the labeling for the Impella RP Flex with Smart Assist System Catheter because the device’s instructions for use fail to appropriately address precautions for clinicians to take when treating patients “whose anticoagulation clotting time is below the recommended value,” posing a risk of blood clots or particle deposits forming.
Patients most at risk are those with central venous lines and cardiac cannulas with systemic anticoagulation below the instructions’ recommendation of 160-180 seconds.
Clinicians may continue to use the devices as this is a voluntary correction, not a product removal. For more information and recommendations, access the FDA website.
Keywords: Anticoagulants, Blood Coagulation Tests, Thrombosis, United States Food and Drug Administration, Cannula, ACC Advocacy
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