Medical device licence · 103424 · Class 3
ICEFX CRYOABLATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 7, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103424
- Licence holder
- Boston Scientific CorporationWatertown, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 7, 2019
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ICEFX CRYOABLATION CONSOLE
- ICEROD 1.5 CX STRAIGHT NEEDLE
- ICESEED 1.5 CX 90 NEEDLE
- ICESEED 1.5 CX S 90 NEEDLE
- ICESEED 1.5 CX STRAIGHT NEEDLE
- ICESPHERE 1.5 CX STRAIGHT NEEDLE
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “icefx”. A notice may cover another product or only some lots: read it to see what it covers.
- ICEfx™ Cryoablation ConsoleSeptember 11, 2025 · Neurology · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.