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 Atrium Medical Corporation Advanta V12 [Model or catalog number: 85361; Lot or serial number: 464909, 464910] [HKMD No.: 090420].
According to Health Canada, the manufacturer is initiating a voluntary medical device recall/removal for the Advanta V12 covered stent system due to an identified manufacturing deficiency that may cause a loss of balloon pressure or inability to hold balloon pressure during Advanta V12 balloon-expandable covered stent deployment.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/advanta-v12-0
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 Oct 2023