Medtronic Inc. is recalling Rashkind Balloon Septostomy Catheters because of device quality issues that may 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 vascular injury and death.
The Rashkind Balloon Septostomy Catheters are used to create an atrial septal defect or to enlarge an existing atrial septal defect as a treatment option for patients with cyanotic congenital heart defects.
There have been 2 reported injuries and 1 death related to this issue. Medtronic has stopped the manufacturing and distribution of Rashkind Balloon Septostomy Catheters for reasons unrelated to this recall.
Food and Drug Administration (FDA). Medtronic Recalls Rashkind Balloon Septostomy Catheters for Quality Issues. November 3, 2020. Available at: click here. Accessed November 3, 2020.