FDA Orders the Recall of Defective Heart Pumps in Pennsylvania

The Food and Drug Administration is working with Abbott Laboratories to investigate some deaths and injuries linked to the use of their devices. Some heart pumps used to support heart failure have been found to collect biological material while being used. This biological material causes a buildup and obstructs blood flow between the aorta and the device. The FDA has recalled more than 14,000 devices.

Two models of heart devices have been given the highest priority recall by the Food and Drug Administration. This announcement by the FDA came on the grounds of being the cause of more than fourteen deaths and hundreds of injuries.

This high-priority recall comes some years after top medical professionals claimed to notice the devices causing more harm than good. The devices in question are the HeartMate II and the HeartMate III. Designed by Thoratec Corporation, this company is a subsidiary of Abbott Laboratories.

However, the FDA has mentioned that these devices will not be removed from the market. Also, Abbott Laboratories countered that it had emailed a response to all its clients who purchased these devices. They claim the mail includes the issues with each model.

The delayed action in the manner of sensitizing the public about these devices raises concerns from experts and safety advocates. People are asking why issues with medical devices approved by the FDA took so long to get to the public. This is in response to a KFF Health News investigation where the errors of both devices were investigated.

An expert in medical device safety and regulation from the University of California in San Francisco, Sanket Dhruva, weighed in on the matter.

He asked why it took so long for the news to get to the public. As long as it involves severe injuries and deaths, the public should have been informed, as some injuries could have been prepared for. He also questioned the rationale behind the surgeons who refused to inform the public. “If some surgeons were aware, they should have ensured other surgeons were not left in the dark about it,” claims Sanket, a seasoned cardiologist.

Both devices are basically mechanical pumps that support blood pumping and flow. It is not common for some to have a weak heart for it is no longer powerful to do so on their own. These devices are used for patients having end-stage heart failure. Most of these patients are either getting a transplant or a more permanent solution when transplants are not the best options.

For the HeartMate III, it helps the heart’s main pumping chamber to pump blood to every other part of the body. It is basically referred to as a left ventricular assist device and is more common for patients on transplant queues.

The FDA press officer in charge of the case, Amanda Hils, chipped in that the FDA is closely working with the subsidiary. It is important to investigate the reported injuries and determine the next course of action for those affected.

Conclusion

A major concern for the Pennsylvania medical community is that a recall of these devices leaves patients needing transplants or otherwise with no options. However, the option is to bring back these devices in and have a look at them. It is not an easy decision, but it is the best one.

“Personal injury cases arising from such medical device failures can be complex and deeply distressing for the affected individuals and their families,” says Attorney Jeffrey P. Lowenthal of Lowenthal & Abrams, Injury Attorneys. “Our firm is committed to helping those impacted by defective devices seek justice and obtain the compensation they deserve for their suffering and losses.”