🇨🇦 Harmony™ Delivery Catheter System

Hazard/Reason: 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.

This page links to official sources. Verify model/lot/batch details in the official notice.