Recall MonitorHealth Products
ICEfx™ Cryoablation Console
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Neurology
Product: ICEfx™ Cryoablation Console
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| ICEfx™ Cryoablation Console | Not applicable. | FPRCH8000-02H |
| ICEfx™ Cryoablation Console | Not applicable. | FPRCH8000 |
| ICEfx™ Cryoablation Console | Not applicable. | FPRCH8000-02 |
| ICEfx™ Cryoablation Console | Not applicable. | FPRCH8000-02R |
| ICEfx™ Cryoablation Console | Not applicable. | FPRCH8000-02D |
Issue
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