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HeartMate 3™ LVAS Implant Kit, HeartMate 3™ System Controller, HeartMate 3™ S...

# Major Recall Alert: HeartMate 3™ LVAS Implant Kit and System Controllers Recalled Due to Backup Battery Fault Alarm

Abbott has initiated a **voluntary medical device recall** for the **HeartMate II® and HeartMate 3™ System Controllers**, including the HeartMate 3™ LVAS Implant Kit, HeartMate 3™ System Controller, and HeartMate 3™ System Controller Low Flow 2.0. This recall comes in response to an increase in customer complaints about the *controller Backup Battery Fault Alarm*, which may lead to safety concerns if proper procedures aren't followed.

This recall does **not involve the physical removal of products** from where they are sold or used but introduces critical guidelines to address customer reports and reduce future alarm incidents.

Read on to learn why this matters, what to do, and how to keep updated on critical recalls.

## Why This Recall is Important

The HeartMate devices play a vital role for patients needing **Left Ventricular Assist Systems (LVAS)** to support heart function. An advisory **Backup Battery Fault Alarm**, signaled by a flashing yellow wrench on the controller interface, has been identified.

While this alarm is not indicative of a pump failure or critical system malfunction, it requires prompt attention to ensure patient safety. The device alarm occurs when the system controller is connected to external power sources such as **14V batteries** or **AC power via the Mobile Power Unit**.

### Key Reasons Behind the Recall:
- Abbott observed an increase in reports related to the **Backup Battery Fault Alarm**.
- Improper handling of the ribbon cable during battery installation or replacement increases the risk of the alarm triggering.
- **No product removal** is needed, but Abbott recommends following safe practices to mitigate risks.

## Details of the Recall

Here are the key facts about the recall:

- **Products Affected**:
- HeartMate 3™ LVAS Implant Kit
- HeartMate 3™ System Controller
- HeartMate 3™ System Controller Low Flow 2.0

- **Reason for Recall**:
An **advisory Backup Battery Fault Alarm**, triggered by improper handling or stress on the ribbon cable interface during installation or replacement of backup batteries.

- **Reported Issues**: Complaints of alarms, though the alerts do not impact pump functionality or critical systems.

- **Duration of Recall**: Ongoing—advisory precautions in place until resolved.

For more detailed information, visit the official recall page here: [Recall Announcement](https://recalls-rappels.canada.ca/en/alert-recall/heartmate-3tm-system-controller).

## What You Should Do

If you or a loved one uses a recalled HeartMate System Controller or LVAS Implant Kit, follow these steps:

1. **Identify and Monitor Alarms**:
- If the yellow flashing wrench (Backup Battery Fault Alarm) is active, first ensure no other alarms are occurring.

2. **Contact Your Clinical Team**:
- Do not attempt to replace the system controller or perform repairs without clinical guidance. Contact your hospital or care provider for specific instructions.

3. **Avoid Excessive Handling of Ribbon Cables**:
- During battery installation or replacement, minimize movement, stress, or pulling at the **ribbon cable and controller interface**. **Never use the ribbon cable to hold or carry the controller's weight.**

4. **Follow the Patient Handbook**:
- Adhere to the instructions in the patient manual for handling devices and troubleshooting alarms.

By following these recommendations, patients and caregivers can mitigate risks associated with the identified fault.

## Stay Safe – Get Instant Recall Alerts

Ensuring the safety and functionality of your medical devices is paramount. Stay informed about urgent recalls to protect your health and well-being.

📲 **Download the MyRecalls App today** to receive instant recall notifications for medical devices, household products, and more! Equip yourself with the tools to stay safe and calm during critical situations.

For detailed updates, always consult official sources: [Canada Recall Alerts](https://recalls-rappels.canada.ca/en/alert-recall/heartmate-3tm-system-controller).

**Your health is our priority!**

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