| TGA Action ID |
RC-2025-RN-00886-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
The Automated Impella Controller (AIC)
Impella Controller, Packaged, AU
Product Code: 0042-0000-AU
Impella Controller, Packaged, UK
Product Code: 0042-0000-UK
Impella Optical Controller, Packaged, AU
Product Code: 0042-0010-AU
Optical, AIC, Impella Connect, Packaged, AU
Product Code: 0042-0040-AU
All lot and serial numbers |
| ARTG Number |
288729 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Abiomed has identified cybersecurity vulnerabilities that have residual risk related to network and physical access that could be compromised and result in uncontrolled risks affecting the AIC Operating System.
If the identified cybersecurity vulnerabilities are exploited, it may affect the essential performance of the compromised AIC. This may potentially result in loss of device control or unexpected pump stop, which could result in a life-threatening injury, permanent impairment, or death.
To date, no life-threatening injury, permanent impairment or death have been reported in relation to the identified vulnerabilities. |
| Instructions for Customers/Users |
- Abiomed is working on security updates and measures to address these cybersecurity vulnerabilities. To mitigate the vulnerabilities risk, an Abiomed field representative will contact customers to implement changes to control the vulnerabilities risk or, if they prefer, to arrange disabling AIC’s network capabilities.
- The AIC may continue to be used as intended. Timing for the availability of the changes is estimated as December 2025.
- If there is suspicion of a cybersecurity event, report to https://www.productsecurity.jnj.com/ |
| Action Commencement Date |
15/10/2025 |
| Responsible Entity |
|
| Contact Information |
0424 960 142 – Senior Sales Manager |