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Icefx™ cryoablation console
Official notice
11 Sept 2025
Last checked
11 Sept 2025
An official Health Canada notice concerns Icefx™ cryoablation console. 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 Published 2025-09-11.
What to do now
Contact the manufacturer if you require additional information.
Recall number
78048
Official notice
2025-09-11
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
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Affected products
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected vehicles were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand
Manufacturer
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Brand: Boston Scientific, Icefx™ Cryoablation Console.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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