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Health Canada Medical devices

HeartMate 3 LVAS Implant Kit and HeartMate 3 System Controller

Issued July 30, 2024
Issue
Abbott is informing customers 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. Recall Start Date: June 28, 2024
Hazard description
Labelling and packaging - Performance
Product
Product name
HeartMate 3 LVAS Implant Kit and HeartMate 3 System Controller
Reference
ID
RA-75837