Product Wiki · Recalls · Health Canada — Medical Devices

Sentiva® Generator — recall 77944

Health Canada — Medical Devices · Canada · 2025-08-20 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
77944
Date of alert
2025-08-20
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Neurology
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/sentivar-generator

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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