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 P Cardiac Pacemakers, Incorporated: a wholly owned subsidiary of Guidant Corporation, a wholly owned subsidiary of Boston Scientific Corporation ACCOLADE MRI Pacemaker [Model or catalog number: L331] [HKMD No.: 150086].
According to Health Canada, Boston Scientific is retrieving specific model l331 ACCOLADE pacemakers due to inadvertent re-use/duplication of certain model/serial number combinations. This duplication occurred during the manufacturing of devices built over the past month. There are no performance concerns with these pacemakers, and they have passed all manufacturing tests. Additionally, there have been no reported adverse events or patient harms related to their use.
For further information, please visit: https://recalls-rappels.canada.ca/en/alert-recall/accoladetm-mri-pacemaker
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 25 Sep 2024