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The U.S. Food and Drug Administration (FDA) has updated the “Early Alert: Heart Pump Controller Issues from Abiomed” communication. The Early Alert has been confirmed as a Class I recall, and the reason for the recall has been updated for clarity. The affected products and recommendations for what to do with the devices have not changed.
As of April 27, Abiomed has reported two serious injuries and one death associated with this issue.
This recall involves updating instructions for using devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as 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 adverse reactions, quality problems, or questions about this recall should contact Abiomed at OneMD-Field-Actions@its.jnj.com.
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