| TGA Action ID |
RC-2026-RN-00383-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Automated Impella Controller (βAICβ) when used in conjunction with left ventricular Impella devices
Software version: 6.0.1β6.0.3 and =7.1
Product Codes: 0042-0000-AU, 0042-0000-UK, 0042-0010-AU, 0042-0040-AU |
| ARTG Number |
288729 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Abiomed has identified a software problem affecting the Automated Impella Controller (AIC) when used with a left ventricular Impella device. The problem may occur in patients with prolonged minimal or absent pulsatility, defined as more than 80 minutes with an aortic placement signal below 12 mmHg.
If a sudden change in left ventricular pressure occurs while left ventricular pressure calculation is active, typically at support levels above P-3, the AIC may restart due to an internal error. Disabling the aortic placement signal and pressure display does not prevent this.
During a restart, the screen becomes blank without warning and the pump stops, leaving the patient unsupported and at risk of cannula regurgitation. After restarting, the pump automatically returns to the previous performance level. Recovery to the prior support level may take up to 75 seconds based on preliminary data. Replacing the AIC does not resolve this problem. |
| Instructions for Customers/Users |
Customers are to:
- Recognise that in cases of prolonged lack of pulsatility (greater than 80 minutes, less than 12 mmHg), followed by a sudden change in left ventricular pressure, an AIC restart may occur at support levels above P-3. Consider the need for additional haemodynamic support in these patients.
- Not replace the AIC console if this occurs, as the problem will recur with a replacement device.
- For patients also receiving veno-arterial ECMO support, maintain ventricular unloading at P-3 or lower to avoid triggering a restart, as the left ventricular pressure calculation is inactive at these levels.
- Note that Abiomed is developing a software update to address this problem. |
| Action Commencement Date |
20/05/2026 |
| Responsible Entity |
|
| Contact Information |
Dfletch1@its.jnj.com - Abiomed Australia |