No image published for this recall

No image published for this recall

Medtronic Neuromodulation Model B35200 - Percept PC BrainSense Implantable Neurostimulator - safety alert

Official notice

5 Jan 2022

Last checked

5 Jan 2022

Medium riskFDA

An official FDA notice concerns Medtronic Neuromodulation Model B35200 - Percept PC BrainSense Implantable Neurostimulator - safety alert. An official FDA notice concerns Model B35200 - Percept PC BrainSense Implantable Neurostimulator. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2022-01-05. Recall numbers: Z-0418-2022. Check the official notice for the complete list. Published 2022-01-05.

What to do now

The source does not provide specific consumer instructions. Follow the official FDA notice for next steps.

Units affected

10,006

Recall number

Z-0418-2022

Official notice

2022-01-05

The hazard

An official FDA notice concerns Model B35200 - Percept PC BrainSense Implantable Neurostimulator. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2022-01-05. Recall numbers: Z-0418-2022. Check the official notice for the complete list.

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.

Event Ids

88889

Recall Numbers

Z-0418-2022

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Affected products

Product 1

Model B35200 - Percept PC BrainSense Implantable Neurostimulator

Units affected

10,006

Risk / hazard

An official FDA notice concerns Model B35200 - Percept PC BrainSense Implantable Neurostimulator. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2022-01-05. Recall numbers: Z-0418-2022. Check the official notice for the complete list.

Where it was sold

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

Location 1

US · United States · MN · Minneapolis

Affected area 1

US · United States · MN · Minneapolis

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Medtronic Neuromodulation. Contact: Medtronic Neuromodulation.

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

medium

Recall details

Recall number

Z-0418-2022

Event id

88889

Units affected

10,006

Status

active

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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