VNS Therapy SenTiva® Duo Generator
Brand(s)
Last updated
Summary
Product
VNS Therapy SenTiva® Duo Generator
Issue
Medical devices - Performance
What to do
Customers to be notified. Instructions to follow on response.
Audience
Healthcare
Affected 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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Neurology
Companies
| Livanova Usa, Inc. |
| 100 Cyberonics Blvd., Houston, Texas, United States, 77058 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76908
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