Abbott recalls HeartMate LVAD System monitors over safety concerns

USA—Abbott, a leading global healthcare company, has initiated a recall of the system monitors for its HeartMate left ventricular assist devices (LVADs) due to ongoing safety concerns.

This decision follows an advisory from the U.S. Food and Drug Administration (FDA) calling for a Class 1 recall, indicating that the use of these devices “may cause serious injuries or death.”

According to the FDA advisory, the monitors exhibited several critical screen issues, including screen freezing, overlapping buttons or screens, unresponsive buttons, distorted text or graphics, and incorrect or missing information on the display.

These malfunctions can cause a clinician to inadvertently change pump settings or press the pump stop button, leading to potentially serious adverse health consequences.

Specifically, a pump stop can result in a decrease in blood pressure and inadequate blood flow (hemodynamic compromise), which may cause stroke, irreversible brain damage, heart or organ failure, and death.

This latest recall follows two previous Class I recalls involving Abbott’s LVADs.

In April, nearly 14,000 Abbott and Thoratec HeartMate left ventricular assist devices were recalled, and another occurred in May.

Abbott decided to implement the current recall after receiving multiple reports of significant issues with the HeartMate monitor screens.

The HeartMate 3 LVAD, approved by the FDA for both long- and short-term treatment of adult and pediatric patients with severe left ventricular heart failure, is the only device of its kind currently available in the U.S. for this patient population.

It works by pumping blood for the patient’s left ventricle, diverting it to other areas of the body.

Cardiologists and cardiac surgeons often rely on these devices before or after a heart transplant, and in some cases, as a permanent destination therapy when no other treatments are viable. The device is used both inside and outside the hospital setting.

Despite its critical role in treating severe heart failure, safety data related to the HeartMate 3 LVAD have raised concerns in parts of the healthcare industry.

A new investigative report from CBS News and KFF Health News highlighted these safety issues.

So far, 14 reported injuries have been associated with the monitor screen problems, although no patient deaths have been reported.

Unlike many recalls, the FDA is not asking customers to return the devices to the manufacturer.

Instead, the agency and Abbott have issued recommendations for clinicians to follow when using the affected devices.

Commenting on the recall to Cardiovascular Business, an Abbott spokesperson emphasized that no serious adverse health consequences are associated with this issue, and no devices are being removed from the market.

The spokesman also noted that as part of their recent communication, Abbott counseled physicians and clinics on overcoming this atypical screen behavior and the importance of utilizing the newer HeartMate Touch controller to avoid challenges with the former System Monitor.

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