No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
No image published for this recall
An official Health Canada notice concerns Automated impella® controller. Abiomed initiated a voluntary medical device recall (correction) to notify customers of identified cybersecurity vulnerabilities related to the operating system in the Automated Impella® Controller (AIC) that have residual risk related to network and physical access that could be compromised and that result in uncontrolled risks affecting the AIC operating system. Product is not being removed, and hospital inventory can continue to be used. Published 2025-10-23.
What to do now
Contact the manufacturer if you require additional information.
Recall number
78358
Official notice
2025-10-23
The hazard
The hazard
Abiomed initiated a voluntary medical device recall (correction) to notify customers of identified cybersecurity vulnerabilities related to the operating system in the Automated Impella® Controller (AIC) that have residual risk related to network and physical access that could be compromised and that result in uncontrolled risks affecting the AIC operating system. Product is not being removed, and hospital inventory can continue to be used.
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.
Recall Numbers
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Turn on recall alertsAffected products
Affected products
Product 1
Product 2
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
Company & contacts
Company & contacts
Brand: Abiomed, Automated Impella® Controller.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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