No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
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Abiomed Impella RP with SmartAssist; Product Number: 0046-0035 - safety alert
Official notice
22 Jan 2025
An official FDA notice concerns Impella RP with SmartAssist; Product Number: 0046-0035. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2025-01-22. Recall numbers: Z-0829-2025. Check the official notice for the complete list.
What to do now
Instructions for consumers are available in the official FDA notice.
Units affected
1,560
Recall number
Z-0829-2025
Official notice
2025-01-22
The hazard
The hazard
Health risk requiring medical assessment
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: Abiomed. Contact: Abiomed, Inc..
Source & status
Source & status
Recall details
Recall details
Recall number
Event id
Units affected
Status
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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