Urgent Field Safety Notice For Harmony Delivery Catheter System By Medtronic Inc

Recall Summary Medtronic is issuing an urgent safety notice for the Harmony Delivery Catheter System. The notice affects units distributed in Germany and the EU. This is classified as a Class I recall, which is the most serious type of device recall.

Recalling firm
Medtronic Inc
Product
Harmony Delivery Catheter System
Reason
Urgent Field Safety Notice for Harmony Delivery Catheter System by Medtronic Inc
Classification
Class I
Category
medical device recall
Country
Germany
Agency
BFARM
Recall date
2026-06-03
Status
Ongoing
Distribution
Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/0b4d73d3-4566-4a69-b3b3-b77731522d89