Pulmonary Valve Catheter Delivery System Recall

1 recall on record · Last recall: Jul 13, 2026

Safety Score

97/100

Excellent

Based on recall frequency and severity over the past 3 years, with older recalls weighted less.

Severity Breakdown

Class I — Serious

Class II — Moderate

Class III — Low Risk

Unclassified

Recall Timeline

FDAJul 13, 2026

Pulmonary Valve Catheter Delivery System Recall: Medtronic Removes Harmony Delivery Catheter System (DCS)

The distal tip in certain lots of the Medtronic Harmony Delivery Catheter System (DCS) may detach which can require endovascular retrieval or surgical intervention.

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