Recall MonitorHealth Products
Automated Impella® Controller
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: Automated Impella® Controller
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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.