Healthcare Apr 27, 2022 06:47 PM (GMT+8) · EqualOcean
On April 26, FDA announced that Medtronic's harmony transcatheter pulmonary valve (TPV) catheter system was listed as a level I recall, which is the most serious recall level, representing that the device may cause serious injury or death. Harmony transcatheter pulmonary valve (TPV) system is the world's first self expanding pulmonary valve. It was once recognized as a "breakthrough device" by FDA. This device was approved by FDA in March 2021. Medtronic initiated an active recall of the catheter system of harmony transcatheter pulmonary valve (TPV) on March 2, 2022. A total of 665 devices distributed in the United States were affected by the recall from April 7, 2021 to January 26, 2022. So far, six complaints of clinical cases have been reported, and a total of one injury and zero deaths are related to the use of the equipment.