Thoratec HeartMate System Monitor Recall Issued Due Screen Problems That May Lead to Brain Damage, Strokes, Death

Abbott Laboratories has issued yet another recall impacting its HeartMate left ventricular assist system (LVAS), due to a risk of monitor screen malfunctions, which have been linked to at least 14 patient injuries.

The U.S. Food and Drug Administration (FDA) announced the Thoratec HeartMate System Monitor recall on June 28, following reports of screen freezes, unresponsive buttons, distorted text and graphics, or even displaying wrong or missing information.

The recalled Heartmate devices are designed to monitor the LVAS system, which helps the heart pump blood from the left ventricle into the aorta, aiding in blood circulation throughout the body. The medical devices provide short- and long-term assistance to adult patients experiencing severe left ventricular heart failure who are awaiting a heart transplant, recovering from cardiac events, or as a permanent solution when a heart transplant is not available.

HeartMate Monitor Screen Problems

The HeartMate Monitor System screen issues can lead to a clinician accidentally changing the pump settings, or even pressing the pump stop button. This can result in a decrease in blood pressure, or not enough blood flowing, which can lead to hemodynamic compromise that can cause strokes, irreversible brain damage, heart or organ failure, or even death.

The manufacturer, Abbott Laboratories, sent a letter to healthcare professionals who use the devices an Urgent Medical Device Correction letter on May 8, warning of the screen problems.

According to the letter, restarting the system monitor resolved the display issues in most cases. However, the FDA has now designated that the correction letter as a Class I recall, the most serious medical device recall classification, suggesting that the screen problems can result in serious patient injuries, and potentially even death.

The recall affects the Thoratec HeartMate System Monitor models 286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT, and L1286INT, with Unique Device Identifier Numbers of 00813024010142 and 00813024010852.

U.S. customers with questions can contact their local Abbott representative or call Abbott Medical Technical Support at 1-800-456-1477.

HeartMate LVAS Problems

The FDA has documented a long history of problems with the HeartMate devices, in a series of warnings and numerous recalls.

In April, another HeartMate II and HeartMate 3 Left Ventricular Assist Systems (LVAS) recall notice was announced, indicating that an accumulation of biological material in the device, typically occurring over two years or more, can cause obstructions, reducing its effectiveness in aiding blood flow.

According to the FDA warning, HeartMate LVAS obstruction problems have been linked to 273 injury reports and at least 14 deaths.

The FDA also announced a HeartMate Touch System recall on March 11, indicating that an error may cause the communication system to disconnect from the patient’s HeartMate controller while a “pump stop” command is running.

At the time the HeartMate recall was announced, the manufacturer indicated that it was aware of at least two serious injury reports involving the presence of static electricity causing power loss to patients.

These types of problems have led to HeartMate recalls and problems for more than a decade.

Given the growing number of HeartMate problems dating back to 2011, lawyers are reviewing potential HeartMate lawsuits for those who have suffered injuries or for families of individuals who have suffered a wrongful death caused by problems with the HeartMate devices.

To determine if you or a loved one may be eligible for a HeartMate recall lawsuit, submit information about your potential claim for a HeartMate recall lawyer to review.