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Automated impella® controller
Official notice
23 Oct 2025
Last checked
23 Oct 2025
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 VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected vehicles were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
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Manufacturer
Phone
Brand: Abiomed, Automated Impella® Controller.
Source & status
Source & status
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Category
Classification
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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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