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Heartware - safety alert

Official notice

24 Jun 2015

Last checked

24 Jun 2015

Critical riskFDA

An official FDA notice concerns Heartware - safety alert. An official FDA notice concerns Heartware. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2015-06-24. Recall numbers: Z-1731-2015. Check the official notice for the complete list. Published 2015-06-24.

What to do now

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

Units affected

3,747

Recall number

Z-1731-2015

Official notice

2015-06-24

The hazard

An official FDA notice concerns Heartware. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2015-06-24. Recall numbers: Z-1731-2015. 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

71239

Recall Numbers

Z-1731-2015

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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 · FL · Miami Lakes

Affected area 1

US · United States · FL · Miami Lakes

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Heartware. Contact: HeartWare Inc.

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

critical

Recall details

Recall number

Z-1731-2015

Event id

71239

Units affected

3,747

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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