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Health Canada Medical devices

VNS Therapy SenTiva Generators

Issued February 5, 2025
Issue
Complaints have been received where the SenTiva generator is reporting a loss of therapy or inability to make therapy changes with the VNS therapy programming system. A reed switch malfunction, resulting in the reed switch sticking in a closed position has been identified as the cause of these device events. Recall start date: January 10, 2025
Hazard description
Performance
Product
Product name
VNS Therapy SenTiva Generators
Reference
ID
RA-76909