Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20582 |
| Brand Name: | Heater Cooler Unit |
| Model: | |
| Affected: | HU 35, HCU 20, HCU 30 & HCU 40 |
| Software version: | |
| Recalling Organisation: | Maquet Australia Pty Ltd (NZ) 12G Andromeda Cres East Tamaki Auckland 2013 |
| Contact Information: | 021 874 882 |
| Manufacturer: | Maquet Cardio Pulmonary GmbH |
| Issue: | Maquet Cardiopulmonary have received reports confirming the presence of Mycobacterial contamination (and other bacterial contaminants) in the system water of Heater and Heater/Cooler devices, mainly used during cardiothoracic surgeries to warm or cool a patient. Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air (aerosolize) through the device's exhaust vent into the environment and to the patient. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 30/8/2016 |
