Recall Monitor
Health Products

Harmony™ Delivery Catheter System

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: Harmony™ Delivery Catheter System
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Harmony™ Delivery Catheter SystemMore than 10 numbers, contact manufacturer.HARMONY-DCS

Issue

Medtronic had received two (2) complaints about Harmony™ DCS distal tip detachment during the implant procedure. A root cause investigation has identified that, due to a manufacturing issue, Harmony™ DCS from specific manufacturing lots may have an increased potential for distal tip detachment under certain procedural or anatomical conditions.

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