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Vanta with adaptivestim technology

Official notice

22 Jun 2023

Last checked

22 Jun 2023

Medium riskHealth Canada

An official Health Canada notice concerns Vanta with adaptivestim technology. Vanta Implantable Neurostimulator (INS) may malfunction after a cardioversion or defrbrillation procedure. The damage/malfunction to the device may no longer allow it to provide therapy or communicate with applications, resulting in a loss of stimulation and the need for an unanticipated surgery to explant/replace the INS. Recall start date : June 6, 2023 Published 2023-06-22.

What to do now

Contact the manufacturer if you require additional information.

Recall number

73868

Official notice

2023-06-22

The hazard

Vanta Implantable Neurostimulator (INS) may malfunction after a cardioversion or defrbrillation procedure. The damage/malfunction to the device may no longer allow it to provide therapy or communicate with applications, resulting in a loss of stimulation and the need for an unanticipated surgery to explant/replace the INS. Recall start date : June 6, 2023

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

73868

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Affected products

Product 1

Affected products - Vanta With Adaptivestim Technology, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 977006

Risk / hazard

Vanta Implantable Neurostimulator (INS) may malfunction after a cardioversion or defrbrillation procedure. The damage/malfunction to the device may no longer allow it to provide therapy or communicate with applications, resulting in a loss of stimulation and the need for an unanticipated surgery to explant/replace the INS. Recall start date : June 6, 2023

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 With Adaptivestim Technology.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

73868

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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