Health product recall

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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