Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Health Canada has posted a medical device safety alert concerning Abiomed Inc. Impella Cp and Impella Cp with Smart Assist [All Lots] [HKMD No.: 180163].
According to Health Canada, there is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (tavr) resulting in destruction of the impeller blades.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/impella-cp
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 3 Jul 2023