Tag: harmony_delivery_catheter_system

FDA Issues Class I Recall for Medtronic Harmony Delivery Catheter System

13 Jul 2026 3:19 p.m. · Source: US Food and Drug Administration

Medtronic's Harmony Delivery Catheter System faces a Class I recall by the FDA due to a risk of distal tip detachment. This serious issue could require secondary intervention and poses significant patient risks, though no serious injuries or deaths are…

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