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HeartMate II® LVAS - System Controller Recall Due to Abbott is initiating a v...

# Major Recall Alert: HeartMate II® LVAS - System Controller Recalled Due to Backup Battery Fault Alarm Issues

Abbott is initiating a **voluntary medical device recall** for the **HeartMate II®** and **HeartMate 3™ System Controllers**, an essential component for patients relying on implanted heart pump devices. This recall, announced on October 2023, does not involve the removal of these devices from usage or sale but focuses on addressing an uptick in complaints about a **Backup Battery Fault Alarm** issue. The alarm is represented by a **flashing yellow wrench** on the system controller's user interface. If you're a patient, caregiver, or clinician using these devices, here’s everything you need to know about this recall and how you can stay safe.

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## Why This Recall is Important

The **HeartMate II® and HeartMate 3™ System Controllers** are lifeline devices designed to support heart function in patients with advanced heart failure. The recall is critical because the **Backup Battery Fault Alarm** can cause unnecessary concern and confusion, especially for patients and caregivers.

When the device is connected to **external power sources like 14V batteries or a Mobile Power Unit**, the Backup Battery Fault Alarm serves as an **advisory message**—not an indication of a critical system failure. However, mishandling during battery installation or replacement could potentially increase alarm frequency. Proper handling techniques and prompt action are essential to avoid unnecessary complications for users.

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## Details of the Recall

Here are the key points about the recall:

- **Reason for Recall**: An increase in customer complaints regarding the **Backup Battery Fault Alarm**.
- **Affected Devices**:
- **HeartMate II® LVAS - System Controller**
- **HeartMate 3™ System Controller**
- **Alarm Description**: Indicated by a **flashing yellow wrench** on the user interface when the controller is connected to external power (14V batteries or AC power via the Mobile Power Unit).
- **Alarm Impact**:
- When connected to **external power**, the warning is **advisory** and does not affect pump functionality.
- This is **not a critical system failure** but should still be evaluated by clinical professionals.
- **Manufacturer Guidance**: Abbott highlights that **improper handling** during backup battery installation or replacement is a key contributing factor to alarm occurrences. Excessive movement or stress on the ribbon cable that connects to the controller—such as using it to hold the controller’s weight—can lead to issues.

For any additional information, you can refer to the **official recall notice**: [Click Here](https://recalls-rappels.canada.ca/en/alert-recall/heartmate-iir-lvas-system-controller).

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## What You Should Do

Abbott provides the following recommendations for clinicians, patients, and caregivers:

- **For Clinicians**:
- Minimize excessive handling, movement, or pulling on the **ribbon cable** when installing or replacing the backup battery.
- Avoid using the cable to carry the weight of the controller.

- **For Patients**:
- Refer to the **patient handbook** for proper use and troubleshooting procedures.
- If the **Backup Battery Fault Alarm** (yellow wrench) activates, first check for any **additional active alarms**.
- Contact your hospital or clinical team immediately for diagnosis and instructions.
- Avoid exchanging the system controller or attempting repairs **without clinical guidance**.

Following proper usage and guidance is critical to ensuring the continued safety of the device and the patient’s health.

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## Stay Safe – Get Instant Recall Alerts

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**Click here to download the app** and stay ahead of product safety updates!

For further questions and detailed instructions about the **HeartMate II® LVAS - System Controller recall**, visit the official [Abbott HeartMate Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/heartmate-iir-lvas-system-controller).

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**Image Source**:
![HeartMate II® LVAS System Controller Recall](https://myrecalls.app/images/products/30295_1760746794.jpg)

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