Health Canada has issued a recall for left-sided Impella heart pumps following reports of severe injuries and deaths associated with the device. Manufactured by Abiomed, a Johnson & Johnson MedTech subsidiary, the recalled Impella heart pumps were subject to similar regulatory action by the U.S. Food and Drug Administration (FDA). The Impella pumps, which are used during high-risk cardiac procedures to support the heart’s circulatory function, have been linked to 49 deaths and 129 injuries in the U.S. and have raised significant concerns about patient safety in Canada.
Health Canada’s recall affects more than 6,600 devices across the country and mandates updates to the device’s instructions. Health Canada also urges medical professionals to take extra care while using these devices. Health Canada has been closely monitoring the situation and is working with Abiomed to ensure that the updated warnings are effectively communicated to all healthcare providers.
If you or a loved one has been affected by an Impella heart pump, please contact Slater Vecchio here.
