Heater-Cooler Unit HCU 40

The ice bracket is attached to the inlet of the cardioplegia tank where ice is produced. To avoid interrupting the water circulation on the cardioplegia side, ice must not cover the opening at the bottom of the tank. Due to its very high thermal conductivity, the ice bracket prevents ice buildup in the affected area and the opening always remains patent. An internal investigation came to the conclusion that the failure rate of the ice bracket becomes unacceptably high after two years.

For devices where the ice bracket was replaced more than 2 years ago:

• The ice bracket shall be replaced as soon as possible free of charge.

For devices where the ice bracket was replaced less than 2 years ago:

• The ice bracket shall be replaced during the next preventive maintenance free of charge.

In the future (not part of this field action):

• The ice bracket will be replaced biennially during preventive maintenance.

Recall start date: January 24, 2025