## Major Recall Alert: Hot AXIOS™ Stent And Electrocautery-Enhanced Delivery System Recalled Due to Deployment and Expansion Issues
Boston Scientific has issued an urgent recall for certain configurations of its Hot AXIOS™ Stent and Electrocautery-Enhanced Delivery Systems. The recall targets specific device sizes—6 mm × 8 mm, 8 mm × 8 mm, and 20 mm × 10 mm—following increased reports of stent deployment and expansion problems during delivery. Importantly, successfully implanted stents remain unaffected by this issue. Here’s what you need to know to stay informed and safe.
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### Why This Recall Is Important
The Hot AXIOS™ Stent and Electrocautery-Enhanced Delivery System is critical in managing pancreatic fluid collections and other related conditions. A malfunction during the deployment phase could lead to procedural delays or complications, potentially impacting patient outcomes.
While this issue is expected to be immediately noticeable to the physician at the time of delivery, the increased frequency of these reports has prompted Boston Scientific to initiate this voluntary recall for patient safety. Acting promptly on such recalls is essential to ensure medical professionals use only safe and reliable devices for their procedures.
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### Details of the Recall
Here are the key points to understand about this recall:
- **Product Name**: Hot AXIOS™ Stent and Electrocautery-Enhanced Delivery System
- **Affected Sizes**:
- 6 mm × 8 mm
- 8 mm × 8 mm
- 20 mm × 10 mm
- **Reason for Recall**: Increased reports of deployment and expansion issues during stent delivery. These malfunctions are detectable during the procedure and do not impact successfully implanted stents.
- **Manufacturer**: Boston Scientific
- **Date Issued**: October 26, 2023
- **Scope**: Canada
For more details, visit the official recall notice at [Health Canada’s official website](https://recalls-rappels.canada.ca/en/alert-recall/hot-axiostm-stent-and-electrocautery-enhanced-delivery-system-0).
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### What You Should Do
If you are a healthcare provider or a facility using the Hot AXIOS™ Stent and Electrocautery-Enhanced Delivery System:
- **Stop Using Affected Products**: Immediately check your inventory and halt the use of the affected sizes (6 mm × 8 mm, 8 mm × 8 mm, and 20 mm × 10 mm).
- **Contact Boston Scientific**: Reach out to the manufacturer to arrange for the return of affected units and guidance on replacements.
- **Report Adverse Events**: Any adverse incidents related to these products should be reported directly to Health Canada or Boston Scientific.
Patients concerned about their procedures should consult their healthcare provider to confirm whether these stents were used and ensure proper follow-up care.
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### Stay Safe – Get Instant Recall Alerts
Product recalls like this emphasize the importance of staying informed about safety updates. To keep you and your loved ones safe:
📲 **Download our free Recall Alerts App** to receive real-time notifications about important recalls affecting medical devices, food, consumer products, and more.
By staying informed, you can act quickly to avoid potential risks and ensure your safety. **Don’t wait—download the app today and stay one step ahead!**
For the official recall notice and further information, visit [Health Canada’s website](https://recalls-rappels.canada.ca/en/alert-recall/hot-axiostm-stent-and-electrocautery-enhanced-delivery-system-0).
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Stay vigilant and proactive in addressing recalls, ensuring the well-being of patients and maintaining trust in healthcare systems.