IRRAS announces voluntary recall on its IRRAflow™ device due to an isolated incident of a battery manufacturing failure
IRRAS AB (IRRAS), a commercial-stage medical technology company focused on designing, developing and commercializing innovative solutions for various brain pathologies, announces that it has notified customers of a voluntary recall and a temporary stop of selling of IRRAflow™, the company’s closed-circuit medical device for the treatment of intracranial bleedings. The reason for the voluntary recall is that the battery, supplied by a well validated external manufacturer, overheated on an IRRAflow™ control unit while charging in standby mode during a routine office demonstration. No patients