Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21594 |
| Brand Name: | Balloon pump |
| Model: | |
| Affected: | CS100 and CS300 Intraortic Balloon Pumps. |
| Software version: | |
| Recalling Organisation: | Maquet Australia Pty Ltd (NZ) 12G Andromeda Cres East Tamaki Auckland 2013 |
| Contact Information: | 021 874 882 |
| Manufacturer: | Datascope Corporation |
| Issue: | The manufacturer has received a complaint involving a CS300 IABP that did not pump due to an electrical test failure code #58 (power up vent tests fail), maintenance code #3, and an autofill failure. An electrical test failure code #58 is caused by a solenoid valve requiring more power than the solenoid driver board can deliver to open the valve. The lack of power prevents the coil from moving the plunger causing the valve not to open. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 28/6/2017 |
