Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28858 |
| Brand Name: | CS - Circulatory assist pump, centrifugal (Bioconsoles) |
| Model: | 560BCS1 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Medtronic Inc |
| Issue: | The initial Correction (Medsafe Ref #27362) required a replacement of the system controller circuit board in a specific population of Bio-Console 560 serial numbers. Since deploying this Correction in March of 2021, the manufacturer has received reports through 03-Jan-2022 in which an electrical issue with the new circuit board prevented the Bio-Console 560 from being powered on prior to clinical use. In response to these reports, the manufacturer is deploying a new system controller circuit board to address the issues recently reported during power up. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 18/1/2022 |
