Recall Monitor
Health Products

Sentiva® Generator

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Neurology
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
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Sentiva® GeneratorMore 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

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