Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37309 |
| Brand Name: | Automated Impella controller with Impella Connect |
| Model: | Product code: 0042-0040-AU - Optical, AIC, Impella Connect, Pkgd, AU |
| Affected: | All lots and serial numbers |
| 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 an increase in complaints due to purge cassette recognition issues resulting from failures of the purge flag component within the purge pressure sensor assembly. The purge flag engages with the purge disc and allows the AIC to recognize that the purge disc is inserted properly. The manufacturer is addressing these failures by replacing the purge flag and purge retainer components within the purge pressure sensor assembly of the AIC. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 21/8/2026 |
