Health Canada — Medical Devices · Canada · 2026-06-04 · Type II
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Reported risk: 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.
Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.
ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.