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Heartware PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU - safety alert
Official notice
13 Dec 2023
Last checked
13 Dec 2023
An official FDA notice concerns Heartware PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU - safety alert. An official FDA notice concerns PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-12-13. Recall numbers: Z-0483-2024. Check the official notice for the complete list. Published 2023-12-13.
What to do now
The source does not provide specific consumer instructions. Follow the official FDA notice for next steps.
Units affected
125
Recall number
Z-0483-2024
Official notice
2023-12-13
The hazard
The hazard
An official FDA notice concerns PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-12-13. Recall numbers: Z-0483-2024. Check the official notice for the complete list.
How to check if you're affected
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.
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Turn on recall alertsAffected products
Affected products
Product 1
Units affected
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Affected area 2
Company & contacts
Company & contacts
Brand: Heartware. Contact: Heartware, Inc..
Source & status
Source & status
Recall details
Recall details
Recall number
Event id
Units affected
Status
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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