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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 2023-06-28. Lots: MON500010, MON400039, MON400017, MON400045. Models: 1521US, 1521GB, 1521IL, 1521DE. Recall numbers: Z-1993-2023. Check the official notice for the complete list. Published 2023-06-28.
What to do now
The source does not provide specific consumer instructions. Follow the official FDA notice for next steps.
Units affected
19
Recall number
Z-1993-2023
Official notice
2023-06-28
The hazard
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 2023-06-28. Lots: MON500010, MON400039, MON400017, MON400045. Models: 1521US, 1521GB, 1521IL, 1521DE. Recall numbers: Z-1993-2023. 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.
Lots
Skus
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Model Numbers
Recall Numbers
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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
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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