Recall MonitorHealth Products
VNS Therapy SenTiva® Duo Generator
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Neurology
Product: VNS Therapy SenTiva® Duo Generator
Issue: Medical devices - Performance
What to do: Customers to be notified. Instructions to follow on response.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| VNS Therapy SenTiva® Duo Generator | More than 10 numbers, contact manufacturer. | 1000-D |
Issue
Complaints have been received on the SenTiva Generator 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