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Carotid Wallstent™ Monorail Recall Due to Boston Scientific is initiating the...

# Major Recall Alert: Boston Scientific Issues Recall of Carotid Wallstent™ Monorail Devices Due to Safety Concerns

Boston Scientific has announced a significant recall regarding specific batches of its **Carotid Wallstent™ Monorail endoprosthesis devices**. The recall, which began on **July 7, 2025**, follows reports from physicians encountering unexpected resistance when attempting to withdraw or retract the **Stent Delivery System (SDS)** after successful stent deployment. This issue has been linked to the interaction with the **guidewire** or **Embolic Protection Device (EPD)**, highlighting a potential safety concern in medical procedures.

Affected healthcare providers and users are encouraged to act promptly to ensure safety and compliance. Below, we break down all the vital information you need to know about this recall.

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## Why This Recall is Important

Medical device recalls, especially those connected to endoprosthesis devices, are critical to patient safety and healthcare outcomes.

The **Carotid Wallstent™ Monorail** is a specialized device used to treat **carotid artery disease**, a condition impacting blood flow to the brain and increasing the risk of strokes. Physicians rely on this device for precise treatment, making any complications a serious concern.

Boston Scientific initiated this recall after receiving multiple complaints from users who reported encountering **greater-than-anticipated resistance** when retracting the **Stent Delivery System**. This unexpected resistance could potentially lead to:

- Extended procedural time, increasing the risk of complications.
- Potential harm to patients if retrieval becomes problematic during surgery.
- Increased frustration or challenges for medical teams managing the device.

The recall is a proactive step to minimize risks and prevent adverse outcomes during critical medical procedures.

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## Details of the Recall

Here’s everything you need to know about this recall:

- **Product Name**: Carotid Wallstent™ Monorail
- **Brand**: Carotid Wallstent™ Monorail
- **Manufacturer**: Boston Scientific
- **Recall Start Date**: July 7, 2025
- **Reason for Recall**: Complaints of greater-than-expected resistance during retraction of the **Stent Delivery System (SDS)** from the guidewire or Embolic Protection Device (EPD).

This issue arises after the stent’s successful deployment, which could unexpectedly complicate the withdrawal of the system. Healthcare professionals who use these devices should verify if they have any affected units.

For the most up-to-date information, visit the **official recall page** [here](https://recalls-rappels.canada.ca/en/alert-recall/carotid-wallstenttm-monorail).

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## What You Should Do

If you use or distribute the **Carotid Wallstent™ Monorail**, here’s how to respond effectively:

- **Medical Facilities & Physicians**:
- Immediately check your inventory for affected batches of the **Carotid Wallstent™ Monorail**.
- Discontinue use of any recalled units to ensure patient safety.
- Contact Boston Scientific for guidance on next steps and product returns.

- **Patients Who Have Received the Device**:
- If you’ve undergone a procedure involving the **Wallstent™ Monorail**, there is no cause for immediate alarm. This issue primarily impacts the delivery system during stent placement, not the stent itself after deployment.
- However, consider speaking with your physician for further reassurance.

For additional support, you can contact Boston Scientific directly or use the recall page for instructions on replacement or refunds.

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## Stay Safe - Get Instant Recall Alerts

It’s crucial to stay informed about recalls impacting medical devices or consumer products. With devices like the **Carotid Wallstent™ Monorail**, your safety depends on timely action and awareness.

Download our app today to get **real-time recall alerts** delivered straight to your smartphone. From medical devices to everyday consumer products, we’ll ensure you never miss important updates.

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For detailed information on this recall, visit the official source: [Carotid Wallstent™ Monorail Recall](https://recalls-rappels.canada.ca/en/alert-recall/carotid-wallstenttm-monorail). Stay safe and proactive!

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Boston Scientific’s recall serves as a reminder of the importance of quality control and swift action to protect patient safety in the healthcare industry. Whether you’re a healthcare provider or a patient, staying informed can make all the difference.

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