Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 35999 |
| Brand Name: | Automated Impella controller with Impella Connect |
| Model: | Matrial number - 0042-0040-AU - Optical, AIC, Impella Connect, Pkgd, AU |
| Affected: | Serial number - IC12674, IC12675 |
| 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 cybersecurity vulnerabilities that have residual risk related to network and physical access that could be compromised and that result in uncontrolled risks affecting the Automated Impella Controller (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 may result in a life-threatening injury, permanent impairment or death. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 22/10/2025 |
