The device, which gained FDA approval in 2021, was part of a voluntary recall in 2022 due to stability concerns. Medtronic worked with the FDA to address the issue, and the Harmony TPV is once again available throughout the United States.
The device, which gained FDA approval in 2021, was part of a voluntary recall in 2022 due to stability concerns. Medtronic worked with the FDA to address the issue, and the Harmony TPV is once again available throughout the United States.