Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24272 |
| Brand Name: | Datascope Balloon pump |
| Model: | CARDIOSAVE Hybrid IABP, CARDIOSAVE Rescue 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 received complaints involving the Cardiosave IABPs regarding the use of certain Intra-Aortic Balloons (IABs) at altitudes above 975 Meters. The Cardiosave may not successfully complete the autofill process required to initiate pumping. This failure may result in either interruption of therapy upon the first maintenance autofill or the inability to start therapy. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 6/3/2019 |
