Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28416 |
| Brand Name: | Balloon pump |
| Model: | |
| Affected: | All Serial numbers |
| Software version: | |
| Recalling Organisation: | Getinge Australia Pty Ltd (NZ) Unit D, Ground Floor, Building A, Millenium Centre 600 Great South Rd Ellerslie Auckland 1051 |
| Contact Information: | 09 272 9039 |
| Manufacturer: | Datascope Corporation |
| Issue: | This notification is an update to the previously initiated action, dated 4 October 2021 regarding Helium overreporting and Battery removal shutdown. The manufacturer has determined that in the presence of some radiated RF disturbances, the Helium Indicator on the Cardiosave IABP would intermittently over-report the remaining Helium Capacity. And Shutdown Upon Battery Removal. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 28/3/2024 |
