CanadaThe Automated Impella® Controller (model/catalogue numbers 0042-0040-CA and 0042-0000-CA; affected units have lot or serial numbers of more than 10 digits — contact the manufacturer for specifics) has identified cybersecurity vulnerabilities in its operating system that could be compromised via network or physical access, resulting in uncontrolled risks to the AIC operating system. Product is not being removed and hospital inventory may continue to be used; contact Abiomed Inc. for additional information.
What's being recalled
Companies: Abiomed Inc., 22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923.
How to identify it
Affected products: Automated Impella® Controller; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 0042-0040-CA
Affected products: Automated Impella® Controller; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 0042-0000-CA
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)