9.12.20
By Mike Smith
The Medtronic Rashkind Balloon Septostomy Catheter is designed to resolve an atrial septal defect by treating an existing atrial septal defect as a treatment option for patients with Cyanotic Congenital heart defects.
According to HealthWise:
An atrial septal defect is an opening in the wall that separates the upper chambers of the heart. It is one of the most common congenital heart defects, which are structural problems that develop before a baby is born or at birth. When an atrial septal defect is present, some oxygen-rich blood that should have been pumped to the body flows from one side of the heart to the other. This blood is then pumped to the lungs. This creates extra work for one side of the heart.
If an atrial septal defect is large, heart failure may occur, although this is not common in children. Many children have no symptoms. So this defect may not be found until a child is older or becomes an adult. A heart catheterization can typically be used to close the opening. This prevents blood from flowing between chambers.
Cyanotic heart defects are defects that allow oxygen-rich blood and oxygen-poor blood to mix. In cyanotic heart defects, less oxygen-rich blood reaches the tissues of the body. This results in the development of a bluish tint (cyanosis) to the skin, lips, and nail beds.
The FDA announced this Class 1 recall, stating that device quality issues have emerged from the clinical use of the Rashkind Balloon Septostomy Catheters. This quality issue can lead to the device breaking, separating or failing during use. If this occurs, use of the affected product may cause serious adverse health consequences such as damage to blood vessels (vascular injury) and death. According to the FDA, there were two injuries reported from this problem and one death. The recall impacts 142 devices.