Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36832 |
| Brand Name: | Automated Impella controller with Impella Connect |
| Model: | Impella Controller, Impella Optical Controller, Optical, AIC, Impella Connect, Optical AIC w/Impella Connect, Optical, AIC, Impella Connect |
| Affected: | Affected serial numbers - AIC with software version 6.0.1–6.0.3 and =7.1 |
| Software version: | |
| Recalling Organisation: | Bio-Excel (NZ) Limited trading as Bio-Excel (Australia) Pty Ltd Unit C6, 9 Tait Place Albany Auckland 0632 |
| Contact Information: | |
| Manufacturer: | Abiomed Inc |
| Issue: | The manufacturer 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. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 21/5/2026 |
