Harmony™ Delivery Catheter System

Medtronic had received two (2) complaints about Harmony™ DCS distal tip detachment during the implant procedure. A root cause investigation has identified that, due to a manufacturing issue, Harmony™ DCS from specific manufacturing lots may have an increased potential for distal tip detachment under certain procedural or anatomical conditions.

Status

Active

Key date

Jun 4, 2026

Provinces

National

Added

Jun 7, 2026