Gothenburg, Sweden January 25, 2019
Getinge informs about a medical device recall for the Maquet Axius Blower Mister
Getinge is informing about a global Medical Device Recall for the Axius Blower Mister. To date, there are no known adverse events associated with serious injury or death. Getinge has reported to relevant competent authorities according to applicable regulations and does not expect the cost for the recall to be material.
The Axius Blower Mister is a contract manufactured product for Getinge. The Axius Blower Mister provides controlled delivery of CO2 and saline during coronary artery bypass surgery. It allows the surgeon to operate a clear bloodless field and complete the anastomosis comfortably. Failure of the Blower mister to deliver a jet of CO2 and saline will impact the ability of the surgeon to complete the anastomosis in a dry bloodless field.
In total 7,880 units of Axius Blower Mister have been distributed globally between September 10, 2018, to January 8, 2019.
All concerned customers have received communication to return the product to Getinge for replacement or credit.
This information is released in order to inform users of mentioned Getinge products, according to applicable requirements by regulatory authorities.
Anna Appelqvist, Vice President Corporate Communications
Phone: +46 (0)10 335 5906