No image published for this recall

No image published for this recall

Sentiva® generator

Official notice

20 Aug 2025

Last checked

20 Aug 2025

Medium riskHealth Canada

An official Health Canada notice concerns Sentiva® generator. 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 Published 2025-08-20.

What to do now

Customers to be notified. Instructions to follow on return and replace affected inventories.

Recall number

77944

Official notice

2025-08-20

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

77944

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Affected products

Product 1

Affected products - Sentiva® Generator, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 1000

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Livanova, Sentiva® Generator.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

77944

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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