Sentiva® Generator
Brand(s)
Last updated
Summary
Product
Sentiva® Generator
Issue
Medical devices - Performance
What to do
Customers to be notified. Instructions to follow on return and replace affected inventories.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Sentiva® Generator | More than 10 numbers, contact manufacturer. | 1000 |
Issue
This is a follow up recall to manufacture ref # FA-NM-HOU-2024-00 issued in January 2025, regarding the reed switch component issue. Livanova received Health Canada approval on July 15, 2025 to distribute updated versions of the model 1000 Sentiva™ and model 1000-D Sentiva Duo™ VNS Therapy™ generators with a design change to resolve the issue and will remove and replace all affected model 1000 or 1000-D generators that remain in hospital inventory.
Recall start date: August 11, 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-77944
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