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Aurora EV-ICD™ MRI SureScan™ Recall Due to There is a potential for delayed t...

# Major Recall Alert: Aurora EV-ICD™ MRI SureScan™ Recalled Due to Delayed High-Voltage (HV) Therapy Risk

The Aurora EV-ICD™ MRI SureScan™ device has recently come under scrutiny following a recall issued due to a potential risk involving delayed delivery of high-voltage (HV) therapy. While the observed cases make up a small percentage of these implanted defibrillators worldwide (0.12%), the issue raises concerns about the efficacy of treatment during critical moments. Here’s everything you need to know about the recall, what it means for patients, and what you should do next.

## Why This Recall is Important

Implantable defibrillators like the Aurora EV-ICD™ MRI SureScan™ play a critical role in preventing life-threatening arrhythmias by delivering timely high-voltage therapy to restore regular heart rhythm. A delay ranging from just **2 to 17 seconds**, as identified in six observed instances during controlled defibrillation testing, could impact defibrillation effectiveness. Although these delays have not been recorded during clinical use, the potential risks highlight the importance of addressing the issue promptly.

Some key details about the recall:
- **Reason for the recall**: Potential for delayed delivery of lifesaving HV therapy under certain rare sequences of events.
- **Observed cases**: Six instances of delay (2-17 seconds) among 4,900 devices globally (~0.12%).
- **Testing conditions**: Five of the observed delays occurred during controlled defibrillation tests—not during actual clinical use.
- **Possible impact**: Delayed HV therapy could affect the device's ability to prevent fatal arrhythmias effectively.

## Details of the Recall

To provide you with more clarity, here are the essential details of the recall:

- **Category**: CAN (Canada)
- **Product Name**: Aurora EV-ICD™ MRI SureScan™
- **Brand**: Aurora EV-ICD™
- **Date of Announcement**: October 2023
- **Scope**: Observations apply to 4,900 implanted devices worldwide.
- **Risk Level**: Low, but important enough to warrant attention given the consequences of delayed therapy.

If you have an Aurora EV-ICD™ MRI SureScan™ implanted, it’s crucial to be informed about next steps and adhere to guidance from your healthcare provider.

## What You Should Do

If you or a loved one has one of these implanted devices, follow these safety measures to ensure your continued health and well-being:

1. **Contact your healthcare provider**: Discuss the recall details with your doctor, who can provide personalized guidance based on your circumstances.
2. **Remain vigilant**: While the delay has not been observed in clinical use, you should stay alert for any potential irregularities or symptoms requiring medical attention.
3. **Follow the manufacturer’s safety measures**: Updates and instructions may be provided by the device manufacturer to prevent or mitigate the rare sequence of events that cause delays.

For further official information about the recall, visit the **Government of Canada Recall Page** here: [Aurora EV-ICD™ MRI SureScan™ Recall Announcement](https://recalls-rappels.canada.ca/en/alert-recall/aurora-ev-icdtm-mri-surescantm).

## Stay Safe – Get Instant Recall Alerts

In today’s fast-paced world, staying informed about medical recalls is crucial to protecting your health. To ensure you never miss critical updates, download our **free Recall Alert App** today. The app provides real-time notifications for recalls in Canada, including health devices, food products, and electronics.

### Features of the App:
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Don’t take chances when it comes to your health. [Download the Recall Alert App](#) now and stay ahead of critical safety updates.

By staying informed and proactive, you can address potential risks promptly and ensure both your safety and peace of mind. Share this blog to help spread awareness of this important recall and let others know how they can protect themselves!

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