FDA Provides Update on Medtronic’s Recall of its Harmony Delivery Catheter System

The FDA has issued an update on Medtronic’s March 2 recall of its Harmony delivery catheter system, deeming it a Class 1 recall because of the risk of serious injury or death.

The device is used to treat a leaky native or surgically repaired right-ventricular outflow tract, the part of the heart that carries blood to the lungs. The delivery catheter is used to implant a replacement valve without the need for open heart surgery. 

The reason for the recall is the possibility that the bond holding the capsule at the end of the delivery catheter may break during a procedure to place the valve.

The 665 affected products were distributed from April 7, 2021, to Jan. 26. There have been six complaints and one injury, but no reported deaths so far, the agency said.