Official recall record
Harmony™ Delivery Catheter System
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2026-06-04
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-06-14.
Record last checked against the registry on 2026-06-14.
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