Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37157 |
| Brand Name: | Intra-Aortic Balloon Balloon pump |
| Model: | Product: Intra-Aortic Balloon CS100 IABP, CS300 IABP |
| Affected: | |
| 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 has become aware of instances where the device did not provide the expected runtime during some portable IABP uses CS100/CS300 devices. The manufacturer recently completed additional testing on the CS100/CS300 batteries and identified the battery runtime and cycle specifications contained in the devices' Instructions for Use (IFU) were incorrect and need to be updated. No other CS100/CS300 IABP performance deficiencies were identified. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 28/7/2026 |
