Getinge is informing about an implemented Class 1 recall for the Cardiohelp Emergency Drive. In total, ten devices were identified. 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 the cost for the recall is not material.
The Cardiohelp Emergency Drive, which is an accessory to the Cardiohelp-i system, is used in emergencies to manually drive the disposable in case of an unforeseen interfereance or malfunction affecting the Cardiohelp-i system. In total, ten Emergency Drives were located in the United States that possibly were affected, all of which have been identified and corrected.
All concerned customers have received communication and have been provided with a substitute product until the correction is finalized.
This information is released in order to inform users of mentioned Getinge products, according to standard procedure recommended by regulatory authorities. It will also be posted on the FDA website as a Class 1 recall.