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Heartware HVAD Pump Kit, REF 1103 - safety alert

Official notice

28 Dec 2022

Last checked

28 Dec 2022

Medium riskFDA

An official FDA notice concerns Heartware HVAD Pump Kit, REF 1103 - safety alert. An official FDA notice concerns HeartWare HVAD Pump Kit, REF 1103. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2022-12-28. Recall numbers: Z-0745-2023. Check the official notice for the complete list. Published 2022-12-28.

What to do now

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

Units affected

5,704

Recall number

Z-0745-2023

Official notice

2022-12-28

The hazard

An official FDA notice concerns HeartWare HVAD Pump Kit, REF 1103. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2022-12-28. Recall numbers: Z-0745-2023. 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

91281

Recall Numbers

Z-0745-2023

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Affected products

Product 1

HeartWare HVAD Pump Kit, REF 1103

Units affected

5,704

Risk / hazard

An official FDA notice concerns HeartWare HVAD Pump Kit, REF 1103. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2022-12-28. Recall numbers: Z-0745-2023. 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 · 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

medium

Recall details

Recall number

Z-0745-2023

Event id

91281

Units affected

5,704

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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