FDA Class I Recall: Medtronic Harmony Delivery Catheter, part of TPV system

April 28, 2022

Medtronic is recalled the Harmony Delivery Catheter because it is possible that the bond holding the capsule at the end of the delivery catheter may break during a procedure to place the TPV.

The US Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

A capsule bond break could cause procedure delays while the device is replaced with a new one or it may require the patient to undergo additional surgeries. Additionally, a capsule bond break while in use during a procedure could cause serious harm to the patient. Those risks include preventing blood flow and/or completely blocking (embolization or occlusion), tearing and/or splitting (perforation or dissection), or other types of damage to the patient’s blood vessels.

 There have been 6 reported complaints from clinical cases, one injury, and no deaths associated with the use of these devices. What to do:

·        Healthcare personnel who plan to implant the Harmony TPV into patients with severe pulmonary regurgitation

·         People who are candidates for valve replacement using the Harmony TPV system 

The Harmony Transcatheter Pulmonary Valve (TPV) System is used to treat a leaky native or surgically repaired right ventricular outflow tract (RVOT), which is the part of the heart that carries blood to the lungs. The Harmony TPV System consists of a transcatheter pulmonary valve and a delivery catheter, the Harmony Delivery Catheter, that is used to implant the replacement valve without open heart surgery. 

The system is indicated for use in children and adults who have severe pulmonary regurgitation, which is when blood flows backward from the RVOT into the right lower chamber (right ventricle) of the heart, and require replacement of the pulmonary valve. 

FDA recall notice