The corrective action is intended to reduce the risk of patient harm as a result of cybersecurity vulnerabilities in the products.
In the United States, nearly 4500 devices will be relabeled and 500 devices removed due to the risk of thrombus formation in the device.
This offending company has “significant” violations regarding reporting corrections and removals to FDA.
FDA has categorized the recall as Class I due to the seriousness of the device issue.
A malfunction can occur during improper exchange of the heart pump’s back-up system controller.
A vibration issue could cause the device to stop therapy.
The issue involves problems removing the balloon sheath during cardiac procedures.
The adjustable devices have been the subject of an increased product complaint rate.
A potential defect could cause the auto-injectors to fail to activate in an emergency.
The shoulder replacement is used on patients with rotator cuff tears.