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Vns therapy sentiva generators

Official notice

5 Feb 2025

Last checked

5 Feb 2025

Medium riskHealth Canada

An official Health Canada notice concerns Vns therapy sentiva generators. Complaints have been received where the SenTiva generator is reporting a loss of therapy or inability to make therapy changes with the VNS therapy programming system. A reed switch malfunction, resulting in the reed switch sticking in a closed position has been identified as the cause of these device events. Recall start date: January 10, 2025 Published 2025-02-05.

What to do now

Customers to be notified. Instructions to follow on response.

Recall number

76909

Official notice

2025-02-05

The hazard

Complaints have been received where the SenTiva generator is reporting a loss of therapy or inability to make therapy changes with the VNS therapy programming system. A reed switch malfunction, resulting in the reed switch sticking in a closed position has been identified as the cause of these device events. Recall start date: January 10, 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

76909

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Affected products

Product 1

Affected products - VNS Therapy SenTiva Generators, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 1000

Risk / hazard

Complaints have been received where the SenTiva generator is reporting a loss of therapy or inability to make therapy changes with the VNS therapy programming system. A reed switch malfunction, resulting in the reed switch sticking in a closed position has been identified as the cause of these device events. Recall start date: January 10, 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, Vns Therapy Sentiva Generators.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

76909

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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