# Major Recall Alert: Encore™ 26 Advantage Kit, Inflation Device, NephroMax™ and UroMax Ultra™ Balloon Dilatation Catheter Recalled Due to Potential Foreign Material Risk
Boston Scientific has issued an urgent recall of specific batches of the **Encore™ 26 Inflation Device**, **Encore™ 26 Advantage Kit**, **NephroMax™ High Pressure Nephrostomy Balloon Catheter**, and **UroMax Ultra™ Balloon Dilatation Catheter**. This recall is due to the potential presence of **foreign material particles** in the Encore™ 26 Inflation Device that may migrate to associated balloon dilatation catheters during use. If unresolved, this issue poses serious safety risks for patients.
This recall began on **August 5, 2025**, and includes devices distributed across Canada. Here’s everything you need to know about the recall and how to stay safe.
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## Why This Recall is Important
The **Encore™ 26 Inflation Device** plays a critical role in medical procedures. It is specifically designed to **create, monitor, and deflate pressure** in balloon dilation catheters used for treatment. However, Boston Scientific’s investigation revealed that **foreign material particles** could migrate into the catheter through affected inflation devices during use.
If these particles transfer to the catheter used for balloon dilation:
- **Patient Safety Could Be Compromised**: The presence of foreign particles could cause procedural complications or adverse events.
- **Risk of Contamination**: Unintended materials in medical devices increase the risk of infection or other medical issues.
This proactive recall aims to prevent potential harm and protect patients by removing compromised devices from circulation.
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### Details of the Recall
Here are the key details of the affected products and why they are being recalled:
- **Brand/Products Involved**:
- Encore™ 26 Inflation Device
- Encore™ 26 Advantage Kit
- NephroMax™ High Pressure Nephrostomy Balloon Catheter
- UroMax Ultra™ Balloon Dilatation Catheter
- **Issue Identified**:
- Foreign material particles in the Encore™ 26 Inflation Device, which may migrate into balloon dilatation catheters during use.
- **Recall Origin Date**: August 5, 2025
Boston Scientific encourages healthcare providers, distributors, and patients to **stop using any affected devices immediately** and carefully follow instructions for returning the recalled products.
[**Learn More About the Official Recall Details Here ›**](https://recalls-rappels.canada.ca/en/alert-recall/encoretm-26-inflation-device-encoretm-26-advantage-kits-nephromaxtm-kits-and-uromax)
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### What You Should Do
If you or your healthcare facility uses the affected products:
1. **Immediately Stop Use**: Cease using any **Encore™ 26 Inflation Devices** from the affected batches, as well as any kits containing them, including:
- Encore™ 26 Advantage Kit
- NephroMax™ Kit
- UroMax Ultra™ Kit
2. **Follow Return Instructions**: Contact the supplier or distributor to arrange for returns or replacements of the affected products.
3. **Notify Your Healthcare Provider**: If you suspect exposure to a recalled device, consult your medical professional to discuss any potential health concerns.
4. **Stay Informed**: Monitor official updates from Boston Scientific and Health Canada for further advice on managing the recall.
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### Stay Safe – Get Instant Recall Alerts
Product recalls can be critical to your health and safety! Protect yourself by staying up-to-date on recalls like this Encore™ 26 device notice.
**Download the MyRecalls App today** and receive instant notifications about product recalls in your area. Be the first to know about safety issues, and take action to protect yourself and your loved ones.
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For further information, consult the official Health Canada recall page: [Encore™ 26 Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/encoretm-26-inflation-device-encoretm-26-advantage-kits-nephromaxtm-kits-and-uromax). Stay informed and stay safe!
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By taking precautionary measures and staying updated on recalls, you can prioritize not only your safety but also the well-being of those around you.