# Major Recall Alert: Automated Impella® Controller Recalled Due to Safety Concerns and Potential Risks
Abiomed, Inc. has issued an urgent voluntary recall of specific Automated Impella® Controllers (AIC) (Product Code: 0042-0000-CA). Following a review of service records, it has been identified that some units may require critical hardware updates to address potential safety concerns. These updates are designed to mitigate risks that could result in a delay or even a loss of hemodynamic support—conditions that can lead to severe injury or even death.
If you use or distribute the Automated Impella® Controller, this is an important safety announcement you cannot ignore. Read on to understand why this recall matters, key details about the recall, and steps to ensure your safety.
## Why This Recall Is Important
The Automated Impella® Controller is a vital medical device built to deliver life-saving hemodynamic support for patients in critical care. Any malfunction or delay in its operation could have dire consequences, including:
- **Loss of hemodynamic support**, which is crucial for stabilizing blood flow in emergency situations.
- **Increased risk of patient injury or death** due to device malfunctions.
- **Urgent need for hardware updates** to ensure the device can continue to operate effectively and safely.
Abiomed’s proactive recall highlights their commitment to patient safety, but swift action on your part is crucial to prevent potential harm.
## Key Details of the Recall
Here are the essential facts you need to know about this recall:
- **Category:** Medical Device Recall
- **Brand/Model Affected:** Automated Impella® Controller (Product Code: 0042-0000-CA)
- **Manufacturer:** Abiomed, Inc.
- **Reason for Recall:** A retrospective review identified the need for specific hardware updates on certain Automated Impella® Controller units to address safety risks, including delays or loss of hemodynamic support.
- **Potential Outcome:** Failure to address these updates may result in severe injuries or fatalities.
- **Announcement Date:** [Date Announced: 2019-03-20]
Abiomed’s goal with this recall is to ensure that all affected devices receive the necessary updates to maintain safety and operational reliability.
## What You Should Do
If you own or operate an Automated Impella® Controller, it’s critical to take the following steps immediately:
1. **Check if Your Device is Affected:** Refer to servicing records or contact Abiomed to confirm whether your unit requires updates.
2. **Contact Abiomed, Inc.:** You can reach out to the manufacturer for guidance on how to proceed with hardware updates.
3. **Follow Manufacturer Instructions:** If your device is affected, follow all provided instructions to have the necessary hardware upgrades performed promptly.
4. **Report Adverse Events:** Any related injuries or issues should be reported to relevant health authorities, including Health Canada, at [Report an Incident](https://recalls-rappels.canada.ca/en/report-problem).
Visit **[official recall notice](https://recalls-rappels.canada.ca/en/alert-recall/automated-impellar-controller-0)** for further details. Abiomed is working diligently to resolve these concerns, but timely action on your part is key to minimize risks.
## Stay Safe – Get Instant Recall Alerts
Don’t miss critical safety updates that could affect you, your loved ones, or your medical practice. Download our free **Product Recall Tracker App** today! Our app notifies you instantly about recalls, keeps you informed with the latest news, and helps you take prompt action to ensure safety.
**Click here to download the app now** and always stay ahead of potential risks.
Your safety is paramount. By acting swiftly on this recall, you’ll help reduce the likelihood of adverse incidents and continue to rely on life-saving devices like the Automated Impella® Controller with confidence.
For more information, always refer to official sources like the **[Health Canada recall page](https://recalls-rappels.canada.ca/en/alert-recall/automated-impellar-controller-0)**.