# Major Recall Alert: ICEfx™ Cryoablation Console Recalled Due to Desiccant Tube Subassembly Issues
Boston Scientific has issued an important recall for the ICEfx™ Cryoablation Console preventative maintenance (PM) kits due to a critical component defect. The affected desiccant tube subassemblies were manufactured with improperly tightened end caps. This flaw could cause the desiccant to absorb excess atmospheric moisture during storage, impairing argon gas drying and restricting flow due to needle clogging. Such issues could alter the therapeutic response of the cryoablation system. Although there are currently no reports of patient harm or complaints linked to this issue, Boston Scientific is taking proactive steps to address the problem.
This recall began on **September 18, 2025**, and highlights the importance of ensuring high standards for medical device safety.
## Why This Recall is Important
The ICEfx™ Cryoablation System is a vital medical device used in minimally invasive procedures to treat various conditions such as cancerous tumors and abnormal tissue. A defect in the PM kits, specifically with the desiccant tube subassemblies, could pose risks to patients by disrupting the system’s functionality and potentially altering the intended therapeutic response.
### Potential Risks:
- Loose end caps on desiccant tubes allow atmospheric moisture absorption.
- Excess moisture could impair argon gas drying performance.
- This can lead to needle clogging and reduced cryoablation effectiveness.
Although no injuries or adverse outcomes have been reported, the nature of the defect underscores the need for prompt attention to mitigate any potential risks.
## Details of the Recall
Here’s a quick breakdown of what you need to know:
- **Category**: Medical Devices – ICEfx™ Cryoablation System
- **Brand**: **Boston Scientific ICEfx™ Cryoablation Console**
- **Affected Component**: Desiccant tube subassemblies in PM kits
- **Issue**: Incorrectly tightened end caps on desiccant tubes
- **Impact**: Potential impairment in gas drying and restricted flow due to needle clogging
- **Reports**: No complaints or patient harm reported to date
- **Recall Start Date**: September 18, 2025
For the official announcement and complete details, visit the official recall source: [ICEfx™ Cryoablation Console Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/icefxtm-cryoablation-console).
## What You Should Do
To ensure patient safety and avoid interruptions in medical procedures, facilities that use the ICEfx™ Cryoablation System should take the following steps:
- **Check Your Inventory**: Assess your PM kit stock and identify any affected components.
- **Contact Boston Scientific**: Reach out to the manufacturer for further instructions regarding replacements or repairs.
- **Follow Guidelines**: Adhere strictly to the service instructions provided by Boston Scientific to prevent potential system failures.
Healthcare professionals and organizations are encouraged to act promptly to maintain optimum device performance and patient safety.
## Stay Safe – Get Instant Recall Alerts
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For more information on this ICEfx™ Cryoablation Console recall, visit the official recall page: [ICEfx™ Cryoablation Console Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/icefxtm-cryoablation-console).
Stay informed. Stay safe. Stay prepared.