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Medtronic EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator - safety alert

Official notice

3 Jul 2024

Last checked

3 Jul 2024

Medium riskFDA

An official FDA notice concerns Medtronic EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator - safety alert. An official FDA notice concerns EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2024-07-03. Recall numbers: Z-2199-2024. Check the official notice for the complete list. Published 2024-07-03.

What to do now

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

Units affected

40

Recall number

Z-2199-2024

Official notice

2024-07-03

The hazard

An official FDA notice concerns EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2024-07-03. Recall numbers: Z-2199-2024. 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

94674

Recall Numbers

Z-2199-2024

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Affected products

Product 1

EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator

Units affected

40

Risk / hazard

An official FDA notice concerns EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2024-07-03. Recall numbers: Z-2199-2024. 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 · Mounds View

Affected area 1

US · United States · MN · Mounds View

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Medtronic. Contact: Medtronic Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

medium

Recall details

Recall number

Z-2199-2024

Event id

94674

Units affected

40

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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