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Vanta implantable neurostimulator (ins)

Official notice

26 Aug 2024

Last checked

26 Aug 2024

High riskHealth Canada

An official Health Canada notice concerns Vanta implantable neurostimulator (ins). The purpose of this recall is to emphasize the impact programming settings can have on the battery life of the Vanta Implantable Neurostimulator (INS) model 977006. Additionally, this letter is intended to remind you of the tools that currently exist in both models A71200 Vanta Clinician Programmer application and A71300 Stimulation Trialing Clinician Programmer application. These tools should be used to assist in selecting the appropriate INS model for the patient and to assess the longevity of the Vanta INS throughout the life of the implant. Recall start date: August 20, 2024 Published 2024-08-26.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75971

Official notice

2024-08-26

The hazard

The purpose of this recall is to emphasize the impact programming settings can have on the battery life of the Vanta Implantable Neurostimulator (INS) model 977006. Additionally, this letter is intended to remind you of the tools that currently exist in both models A71200 Vanta Clinician Programmer application and A71300 Stimulation Trialing Clinician Programmer application. These tools should be used to assist in selecting the appropriate INS model for the patient and to assess the longevity of the Vanta INS throughout the life of the implant. Recall start date: August 20, 2024

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

75971

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Affected products

Product 1

Affected products - Vanta Implantable Neurostimulator (INS), Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 977006

Risk / hazard

The purpose of this recall is to emphasize the impact programming settings can have on the battery life of the Vanta Implantable Neurostimulator (INS) model 977006. Additionally, this letter is intended to remind you of the tools that currently exist in both models A71200 Vanta Clinician Programmer application and A71300 Stimulation Trialing Clinician Programmer application. These tools should be used to assist in selecting the appropriate INS model for the patient and to assess the longevity of the Vanta INS throughout the life of the implant. Recall start date: August 20, 2024

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: Medtronic, Vanta Implantable Neurostimulator.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

high

Recall details

Recall number

75971

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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