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Automated Impella® Controller Recall Due to Abiomed initiated a voluntary med...

# Major Recall Alert: Automated Impella® Controller Faces Cybersecurity Vulnerabilities in AIC Operating System

Abiomed, a renowned manufacturer of medical devices, has issued a **voluntary recall (correction)** to address cybersecurity vulnerabilities in the **Automated Impella® Controller (AIC)**. These vulnerabilities pose a residual risk related to network and physical access, potentially compromising the AIC operating system and leading to uncontrolled risks. It’s important to note that while the product is not being removed from hospitals, healthcare facilities must be aware of this advisory and implement necessary safety measures. Read on to learn more about this critical update and how to mitigate risks.

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## Why This Recall is Important

The **Automated Impella® Controller (AIC)** is a vital device used in hospitals to operate Impella heart pumps, providing life-saving circulatory support for patients with severe heart failure. The identified **cybersecurity vulnerabilities** in its operating system could pose serious risks if exploited.

- **Impact:** Unauthorized access to the device’s network or physical controls may lead to disturbances in its operation, which could put patients at risk of harm.
- **Continued Use:** Abiomed has decided that hospital inventories can continue to use the device, but users must be aware of the risks and take action to protect the system.

This recall (correction) is not a physical removal but a proactive approach to ensure patient safety while minimizing disruptions to critical medical care.

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## Details of the Recall

Abiomed announced this recall on **October 20, 2023**, notifying healthcare systems and key customers about the issue. Here's a breakdown of the recall specifics:

- **Product:** Automated Impella® Controller
- **Recall Type:** Voluntary correction, not removal
- **Reason for Recall:** Cybersecurity vulnerabilities affecting the operating system of the AIC, with potential risks stemming from network and physical access.
- **Patient Impact:** If exploited, these vulnerabilities could lead to unsafe operation, posing a serious risk to patient safety.

Abiomed is working actively with appropriate authorities to develop solutions to mitigate risks and ensure the highest level of security within its operating systems. For more details, you can access the official recall announcement [here](https://recalls-rappels.canada.ca/en/alert-recall/automated-impellar-controller).

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## What You Should Do

Hospitals and healthcare providers utilizing the **Automated Impella® Controller** should take these steps to safeguard the device:

1. **Review the Notification:** Ensure that staff is fully informed about the identified vulnerabilities and the best practices for safe usage.
2. **Assess Device Security:** Evaluate network access controls and physical security around the AIC unit to mitigate unauthorized access.
3. **Stay Updated:** Remain in close contact with Abiomed for software updates or additional instructions to bolster system security.
4. **Remain Vigilant:** Monitor devices during critical operations and have contingency plans in place for any potential disruption.

Abiomed has clarified that the medical device is safe to use within hospitals, provided proper security measures are implemented. Patients can rest assured that necessary precautions are being taken to maintain safety during emergencies.

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## Stay Safe – Get Instant Recall Alerts

Recalls like these emphasize the importance of being informed about potential risks and corrective actions for critical medical devices. To stay updated on recalls, safety notices, and alerts relevant to healthcare equipment, download our **free Recall Alert App today**.

By signing up, you’ll gain:
- Real-time alerts for recalls in your region
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Don’t compromise on safety. [Download the app](https://recalls-rappels.canada.ca/en/alert-recall/automated-impellar-controller) to stay one step ahead of potential risks and ensure patient well-being in your healthcare practice.

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The **Automated Impella® Controller recall** highlights the growing importance of cybersecurity in medical devices. Abiomed’s proactive response underscores a commitment to safety, but it’s up to hospitals and healthcare providers to take the necessary precautions to maintain trust in these life-saving technologies. Stay informed, stay prepared.

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