The purpose of the urgent medical device correction notification is to advise healthcare professionals that Berlin Heart is conducting a voluntary correction concerning all Excor cannulae due to the potential of partial or complete breaches of an Excor cannula. A significant cannula breach may result in massive blood loss and/or an air embolism which could result in blood loss and/or death to the patient. No product will be removed. Recall Start Date: August 4, 2023
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