A pair of heart devices has been given the FDA’s highest priority recall of Class 1 after it was found to have caused hundreds of injuries and more than 10 deaths in Florida. Thoratec Corp., one of several subsidiaries of Abbott Laboratories, is recalling its products, HeartMate II and HeartMate III. While the products are not being banned from the market, they are being simply recalled. Interestingly, Abbott Laboratories affirmed that customers had been informed this year without a mention of when exactly. This recall comes several months after medical surgeons in Louisiana noticed some side effects with both products.

While an investigation by KFF Health News just last year highlighted how both products have been connected to numerous reports of several deaths and many injuries, the delayed action of the company and the fact that the FDA just found out raise suspicions for safety advocates about how issues of this caliber are reported and handled. If you or a loved one has been affected, a team like Tomeny Best can help you understand your legal options.

HeartMate II and HeartMate III Overview

HeartMate II and HeartMate III comprise a pair of mechanical pumps that assist the heart in pumping blood when it cannot do so by itself. These devices are as small as snail shells that can be fitted into a full-grown man’s palm. They are implanted by surgery in patients with end-stage heart failure who usually need a transplant or otherwise.

The recall affects close to 14,000 devices. Patients in Louisiana and across the country who have these devices should stay in close contact with their doctors and monitor for any unusual symptoms.

The HeartMate Devices

The HeartMate III is basically a mechanical pump designed for patients suffering from end-stage heart failure. Technically called a left ventricular assist device, this “pump” assists the heart’s main pumping chamber to pump blood into the body. Both devices are commonly used by patients who are waiting for long-term therapy or a heart transplant.

The HeartMate III is powered by a cable attached to the pump and exits the body through a predetermined surgical opening. It is then connected to a controller having batteries or any other power source.

The HeartMate II is a similar device but is tagged as an axial-flow device, while the HeartMate III is a pulsatile-flow system having no mechanical bearings.

An FDA press officer affirmed that the agency is closely working with Abbott in the investigation to get a more accurate report of the injuries and deaths and determine what action to take next.

According to the FDA’s recall database, the devices induce a buildup of biological material, which reduces their ability to assist the heart in circulating blood, effectively reducing the lifespan of the patients. The buildup builds up steadily but does not appear on scans until two years or more after these devices are implanted in patients’ chests.

How Should Doctors Handle These Emergencies?

While Abbott claims it has informed many customers, there is no press release about informing hospitals and doctors in the event that they have to receive an emergency caused by these devices. The FDA, however, put out warnings for doctors to be on alert for low-flow signals on these devices.

If they can, in some way, diagnose the obstruction (its exact location), they are to plant a stent, release the blockage, or replace the pump altogether. Otherwise, they could also keep the patient under close monitoring if a surgery cannot be performed at the moment.

However, a spokesperson from Abbott, Justin Paquette, mentioned in an email that “there are currently low rates of outflow obstruction” and that patients whose devices had no issues have no cause for concern.

Conclusion 

“The recall of HeartMate devices underscores the importance of rigorous safety protocols and ongoing monitoring in the medical device industry,” says attorney Frank Tomeny III of Tomeny Best.

These news reports may be causing concern among Louisiana patients who have undergone the procedure. Nevertheless, the FDA is working on the matter, so patients are advised to stay calm and await more instructions from the manufacturers and the FDA.