Thoratec HeartMate System Monitor Recall

Abbott Medical has issued a correction for its Thoratec HeartMate System Monitor due to atypical monitor screen behaviors that can cause the unit to freeze or become unresponsive. These issues could cause injury or death in a patient who has received a HeartMate device.

This urgent medical device correction will not remove the devices from the market. Instead, this recall instructs surgeons to be aware of monitor problems and to take steps to reduce the likelihood of a screen error occurring.

Left Ventricular Assist Device (LVAD)

An LVAD is a device that assists patients with heart failure by helping the heart pump when it cannot pump fully on its own. LVAD devices are designed to improve quality of life and survival rates for people waiting for a heart transplant.

The mechanical pump operates by pumping blood from the left ventricle to the aorta, and then the rest of the body. Proper blood flow is critical to survival, and interrupted or intermittent blood flow can cause severe injury or death in a patient, thus the reason proper LVAD operation is so critical.

Left Ventricular Assist System (LVAS)

The LVAD system monitors the device to ensure that it pumps the heart.

HeartMate System Monitor

The HeartMate Left Ventricular Assist System (LVAS) has many parts. One of these parts is the system Monitor, which is used for the following purposes.

Monitor system operation during the LVAD implant
Display current operating mode, pump flow, pump speed and overall status during the operation
Program the systems parameters
Track alarm conditions
View and save performance data
Record data at specific intervals to download for review and analysis

Screen Issues Regarding the Monitors

The HeartMate Left Ventricular Assist System (LVAS) Monitors encounter screen issues, which can cause the screen to freeze, distort, become unresponsive, or stop working. This can be extremely dangerous for users. Clinicians should be aware of the following when dealing with the system monitors.

The System Monitor unit should be restarted before it is connected to the patient controller.
The on and off switch is located on the back of the system monitor and a full restart of the system will last about 10 seconds.
Cables and connections should be checked if screen display issues continue after restart.
If screen issues continue, use a different System Monitor.

Atypical Behavior of the System Monitor

Abbott medical is recalling the HeartMate System Monitor because of its atypical behavior. The LVAS System Monitor has had reports of the following issues.

Screen Freezing
Overlapping buttons or screens
Unresponsive buttons
Distorted text or graphics
Wrong or missing information on the display

Issues could result in clinician users to change pump settings or press the pump stop button.

If the pump stops, it may result in inadequate blood flow and a decrease in blood pressure. This could lead to serious health consequences including stroke, brain damage, heart or organ failure and death.

Reported Injuries

There have been 14 total reported injuries with the HeartMate System Monitor. Luckily there have been no reported deaths from the system monitor issues.

List of Affected Devices

UDI-DI

00813024010142
0081324010852

Model Numbers

1286
L1286
1286A
L1286A
1286A-US
L1268A-US
1286C
L1286C
L1386
1286A-CAN
1286INT
L1286INT

How We Can Help

Our personal injury law firm can provide resources for those affected by LVAD System Monitors. Our experts can help you understand your options and guide you through the legal process.

Those who depend on an LVAD already endure significant challenges. They face a demanding daily routine along with adhering to strict medication schedules.

The physical and emotional burden that exists when managing an LVAD can be substantial. These patients may experience discomfort and lifestyle limitations. Living with a chronic condition and the constant concern about the device malfunctioning can be overwhelming. This recall indicates yet another issue with Abbott’s LVAD systems and is yet another example of a recall involving Abbott’s HeartMate products.

Contact us if you are a loved one who has experienced an issue with the failure of a LVAS monitor, or with an LVAD system.