Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36628 |
| Brand Name: | Impella Purge Cassette |
| Model: | Purge Cassette, 5 Pack, Impella CP Smart Assist Set |
| Affected: | Product code - 0043-0003, 0048-0014. All Unexpired Generation 1 Purge Cassette(s) |
| 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 issued a device recall (removal) of Purge Cassette (Generation 1) due to an increased risk of purge leaks. An updated Purge Cassette (Generation 2) has been developed with a lower risk of purge leaks. The purge cassette delivers rinsing fluid to the Impella catheter. The purge fluid flows from the purge cassette through the catheter to the microaxial blood pump to prevent blood from entering the motor. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 11/3/2026 |
