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Heart Pump Recall: Abiomed, Inc. Updates Use Instructions for Impella RP with SmartAssist and Impella RP Flex with SmartAssist Due to A Risk That the Tip of Guidewires or Other Medical Devices May Come into Contact with The Impella Pump During Insertion, Adjustment, Or Removal
Abiomed Inc. has updated the use instructions for the Impella RP with SmartAssist and Impella RP Flex with SmartAssist due to a risk that the tip of guidewires or other medical devices may come into contact with the Impella pump during insertion, adjustment, or removal. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop. This may trigger alarms and cause a loss of certain heart and blood pressure readings.
This recall involves updating instructions for using certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as a Class I recall, the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Questions?
Customers in the U.S. with questions about this recall should contact Abiomed at onemd-field-actions@its.jnj.com.
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