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Irras initiates voluntary recall of brain medical device due to battery defect

Stockholm-based Irras AB initiated a voluntary recall of its IRRAflow device due to battery defect.

IRRAflow is a closed-circuit medical device for treating acute bleeding inside the skull or brain.

According to Irras, during a demonstration one unit's battery overheated while charging on standby mode, an incident that the company believes is an isolated case of manufacturing failure.

The company has also stopped selling the device and started the replacement process for the affected control units.

Irras noted that despite the effects of the recall on 2017 sales of the device, its goal of exceeding sales of 250 million Swedish kronor for 2020 still remains.

Irras makes medical equipment for a range of brain pathologies in Sweden and internationally.

As of Dec. 12, US$1 was equivalent to 8.44 Swedish kronor.