Official recall record

ICEfx™ Cryoablation Console

Health Canada — Medical Devices · 2025-09-11 · CanadaType II

Issuing authority: Health Canada — Medical Devices
Published: 2025-09-11
Country of alert: Canada
Alert level: Type II
Alert type: recall

What the authority reported

Boston Scientific has identified that certain desiccant tube subassemblies, a component of the preventative maintenance (PM) kits used to service ICEfx™ Cryoablation System, were built with end caps that were not correctly tightened. Loose end caps could allow the desiccant to absorb excess atmospheric moisture during storage, potentially impairing argon gas drying and restricting flow due to needle clogging, which could alter therapeutic response. To date Boston Scientific has not received any complaints or reports of patient harm associated with this issue. Recall start date: September 18, 2025

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 2026-05-31.

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