Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27514 |
| Brand Name: | Balloon pump |
| Model: | |
| Affected: | Cardiosave Hybrid IABP - All Lots, Cardiosave Rescue IABP - All Lots |
| 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: | The manufacturer investigation revealed that five (5) of the nineteen (19) vulnerabilities may affect the operating system in Cardiosave IABP devices. If any of the vulnerabilities were exploited, Ethernet communication would be lost, and the Cardiosave will not be able communicate to the Hospital Information System/Clinical Information System (HIS/CIS) to send therapy and waveform data |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 30/3/2021 |
