FDA MedWatch Safety AlertsOriginal article
Pulmonary Valve Catheter Delivery System Recall: Medtronic Removes Harmony Delivery Catheter System (DCS)
RegulatoryHarmony Delivery Catheter System (DCS)Negative
AI Analysis
Summary
Medtronic issued a recall of its Harmony Delivery Catheter System due to potential distal tip detachment in certain lots that may require endovascular retrieval or surgical intervention.
Outcome Details
Product recall due to potential distal tip detachment in certain lots
Importance:6/10
Sentiment:
-0.80
recalldevice safetycardiovascularregulatory action
Related Companies
Read the original article
Published by FDA MedWatch Safety Alerts on July 13, 2026 4:00 AM