Tuesday, June 18, 2024

Ventricular Assist System Recall: Abbott Addresses HeartMate 3 Blood Leakage and Air Entrapment Issues

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Abbott has issued a recall for the HeartMate 3 left ventricular assist system following reports of blood leakage and air entrapment between device components. This recall, announced after a thorough review of complaints, marks the third instance related to issues with the HeartMate pump since March. The Food and Drug Administration (FDA) disclosed in a recall notice that Abbott reported a total of 81 incidents, including 70 injuries and two deaths, associated with this problem. While classified as a Class I recall, the most severe type, this action does not mandate the removal of the product from circulation.

This recall adds to Abbott’s previous recalls of the HeartMate pump, including a February recall due to a separate issue and another in April related to the potential buildup of biological material in thousands of HeartMate II and HeartMate 3 left ventricular assist systems. Additionally, Abbott recently recalled a HeartMate communication system. The HeartMate pump plays a crucial role in supporting blood circulation in patients with severe left ventricular heart failure, serving as a bridge to heart transplant or assisting the heart in recovery, both within and outside the hospital setting.

The issue of blood leakage or air entering the device was noted during implantation in all reported complaints. Such complications can compromise the integrity of blood flow, potentially leading to longer-than-expected surgeries, hemorrhage, right heart failure, or air embolism. The recall affects 882 devices distributed in the U.S. from March 1, 2021, onwards. Abbott initiated the recall on March 13, accompanied by an urgent medical device correction notification to customers on March 20.

Abbott Issues Guidance for Healthcare Providers Following Ventricular Assist System Recall

In response to the recall of the HeartMate 3 left ventricular assist system, Abbott has issued specific guidance to healthcare providers to ensure appropriate management in cases where blood leakage or air entrapment is suspected or observed during surgical procedures. Abbott has underscored the importance of adhering to standard surgical protocols and following the device’s existing instructions for use to mitigate potential risks associated with these issues. By providing clear directives, Abbott aims to support healthcare professionals in effectively addressing any concerns related to the integrity and performance of the HeartMate 3 left ventricular assist system.

Furthermore, Abbott has made a significant decision not to request the return of unused devices implicated in the recall. Instead, these devices will remain in circulation, as the company continues to assess the situation and implement necessary corrective measures. This approach reflects Abbott’s commitment to transparency and accountability, ensuring that all relevant stakeholders are informed and involved in the ongoing management of the recall process.

The current recall of the HeartMate 3 left ventricular assist system adds to Abbott’s history of similar actions concerning HeartMate devices. In February, the company initiated recalls related to separate issues, which were linked to reports of 273 injuries and 14 deaths involving 13,883 devices distributed in the U.S. These recalls underscore the importance of proactive monitoring and intervention to address potential safety concerns associated with medical devices.

Ventricular Assist System

Abbott Recalls Ventricular Assist System Over Malfunction Risks, Emphasizes Patient Safety

In January, Abbott issued a recall for a communication system utilized to monitor patients implanted with the HeartMate 3 left ventricular assist system. This recall was prompted by concerns over potential malfunctions that could result in the pump inadvertently stopping or starting. By promptly addressing these issues and implementing corrective actions, Abbott aims to uphold the highest standards of safety and quality in the provision of healthcare technologies.

It’s important to recognize that recalls are an integral part of ensuring the safety and efficacy of medical devices. While they may disrupt normal operations temporarily, recalls serve as essential mechanisms for identifying and addressing potential risks to patient health and well-being. By promptly responding to issues and collaborating with regulatory authorities and healthcare providers, Abbott demonstrates its commitment to prioritizing patient safety above all else.

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Moving forward, Abbott remains dedicated to ongoing monitoring and assessment to identify and mitigate any potential risks associated with its medical devices. Through continued vigilance and collaboration with stakeholders, Abbott aims to uphold its reputation as a trusted provider of innovative and reliable healthcare solutions, prioritizing patient welfare and quality of care above all else. It’s worth noting that Abbott became the sole supplier of left ventricular assist devices (LVADs) in the U.S. following Medtronic’s withdrawal of its HeartWare pump from the market in June 2021. Consequently, the FDA recommended healthcare providers use Abbott’s HeartMate 3 left ventricular assist system as an alternative.

 

Resource: Food and Drug Administration, May 15, 2024

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