FDAsafety guidance72% confidence
Pulmonary Valve Catheter Delivery System Recall: Medtronic Removes Harmony Delivery Catheter System (DCS)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (ild) as adenotonsillar hypertrophy treatment protocols.
Regulatory Analysis
The distal tip in certain lots of the Medtronic Harmony Delivery Catheter System (DCS) may detach which can require endovascular retrieval or surgical intervention.
Supporting Context
- Therapeutic area
- ENT · Surgical Intervention
- Sub-indication
- Ild
Related signal: Feasibility Study on IRE System for Adenotonsillar Hypertrophy in Children