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Harmony™ delivery catheter system

Official notice

4 Jun 2026

MediumHealth Canada

An official Health Canada notice concerns Harmony™ delivery catheter system. 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. Published 2026-06-04.

What to do now

Contact the manufacturer if you require additional information.

Recall number

82164

Official notice

2026-06-04

The hazard

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Skus

HARMONY-DCS

Other

RA RA-82164

Model Numbers

HARMONY-DCS

Recall Numbers

82164

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Affected products

Product 1

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - HARMONY-DCS

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Medtronic.

Source & status

Source

Health Canada

Tier

beta

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

82164

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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