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 Thoratec Corporation HeartMate 3 LVAS Implant Kit and HeartMate 3 System Controller [Model or Catalog Number: 106524US and 106531US] [HKMD No.: 180052].
According to Health Canada, the manufacturer is informing users about the potential for marginally lifted User Interface (UI) membranes that users may observe or may have observed in a limited number of HeartMate 3 System Controllers. If the UI membrane is lifted, in certain circumstances when the controller is exposed to water, there is a potential for water ingress into the HeartMate 3 System Controller. Water ingress has the potential to result in problems with the LED display or unresponsive buttons.
For further information, please visit: https://recalls-rappels.canada.ca/en/alert-recall/heartmate-3-lvas-implant-kit-and-heartmate-3-system-controller
If you are in possession of the affected products, please contact your supplier for necessary actions.
Identified on 22 Jul 2024