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
RecallTracker