Medtronic has announced a recall of the delivery catheter component in the company’s transcatheter pulmonary valve system due to risk for capsule break during use.
The FDA has designated the recall as class I, the most serious type of recall.
According to an FDA press release, the transcatheter pulmonary valve system consists of a transcatheter pulmonary valve and delivery catheter (Harmony Delivery Catheter System), used to implant a replacement valve without open heart surgery in children and adults with severe pulmonary regurgitation.
The bond holding the capsule at the end of the