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The official notice did not include a photo. Check the product details and identifiers below.
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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 product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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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 products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Boston Scientific, Icefx™ Cryoablation Console.
Source & status
Source & status
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Tier
Category
Classification
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Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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