The Harmony Delivery Catheter System is the tool. For a parent whose teenager had a Harmony valve placed last year, the correct takeaway is that nothing changes. The newest confirmed fact is that certain Harmony delivery catheter lots have been pulled over a tip detachment risk, with no serious injuries or deaths reported as of mid-May. Medtronic reported no serious injuries and no deaths associated with this issue as of May 14, 2026.Who receives a Harmony valve? Medtronic recalled the Harmony delivery catheter in 2022 over a breakage risk and later relaunched the system after working with the FDA.