Harmony™ Delivery Catheter System

Harmony™ Delivery Catheter System Recall The Harmony™ Delivery Catheter System is being recalled in Canada due to a device performance issue. This is a Class II recall, meaning the product could cause temporary or medically reversible adverse effects, though serious injury is unlikely. The affected devices were distributed across Canada.

Product
Harmony™ Delivery Catheter System
Reason
Device performance issue
Classification
Class II
Category
medical device recall
Country
Canada
Agency
HC-DEVICES
Recall date
2026-06-04
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/4a15fe0c-2ba0-496b-8783-bae16b657083