Automated Impella® Controller
Brand(s)
Last updated
Summary
Product
Automated Impella® Controller
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products | Lot or serial number | Model or catalogue number |
---|---|---|
Automated Impella® Controller | More than 10 numbers, contact manufacturer. | 0042-0040-CA |
Automated Impella® Controller | More than 10 numbers, contact manufacturer. | 0042-0000-CA |
Issue
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Abiomed Inc.
22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-78358
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