Sentiva® Generator
Brand(s)
Summary
Customers to be notified. Instructions to follow on return and replace affected inventories.
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
| Livanova Usa, Inc. |
| 100 Cyberonics Blvd., Houston, Texas, United States, 77058 |
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