Monday, May 27, 2024

Urgent FDA Alert: Abbott Recalls HeartMate Devices Linked to 14 Fatalities

In a critical update, the U.S. Food and Drug Administration (FDA) has mandated a recall of approximately 14,000 HeartMate left ventricular assist devices (LVADs) by Abbott and its subsidiary Thoratec. The recall comes in response to severe safety concerns, primarily due to a buildup of biological material in the devices, which has led to 14 deaths and numerous injuries.

The FDA has classified this as a Class I recall, the most severe category, indicating a high risk that the device may cause serious injuries or fatalities. The affected models, HeartMate II and HeartMate 3 LVADs, have shown complications from the accumulation of biological materials, which can hinder the device’s effectiveness and trigger critical low blood flow alarms.

This accumulation, generally developing over two years or more, can significantly obstruct the device’s operation, potentially leading to fatal outcomes. Despite these concerns, the recall is corrective rather than a total withdrawal, meaning patients with devices that are not exhibiting persistent low-flow alarms need not worry, according to an Abbott spokesperson.

The FDA’s advisory highlights the importance of monitoring for these alarms, which could indicate the onset of dangerous obstructions. An Urgent Medical Device Correction notice issued on February 19th to Abbott’s customers included comprehensive guidelines on diagnosing and managing these issues effectively.

Furthermore, the HeartMate 3 LVAD remains the only device approved by the FDA for both long and short-term management of patients with advanced heart failure in the U.S., underscoring its critical role in supporting this high-risk patient group. The device functions by aiding the heart’s left ventricle in pumping blood throughout the body, crucial for patients awaiting a heart transplant or as a permanent solution when other treatments fail.

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