FDA Issues Class I Recall for Medtronic HeartWare Heart Pumps

By Gilreath & Associates

The U.S. Food and Drug Association (FDA) issued a Class I recall for thousands of Medtronic HeartWare HVAD System Battery Chargers used with the HeartWare HVAD System. This system is designed to help patients with heart problems (specifically the left ventricle) pump blood throughout their bodies.

The defect was found in the battery charger and AC adapter, which can be accidentally inserted into the HeartWare HVAD system’s controller power port. This can cause damage to the communication circuits between the battery and controller. Failure could lead to exacerbation of heart failure and other severe symptoms or repercussions amongst users.

What is a Class I recall?

Medtronic issued the first recall in January 2020 after dozens of complaints from consumers and 1 death.

On March 9, 2020, the FDA issued its Class I recall, which means “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

The FDA determined the device’s design was to blame for the high risk, and their recall “affects all serial numbers of the HeartWare Battery Charger packaged with AC Adapter model number 1610 and HeartWare Battery Charger AC Adapter model number 1640.”

According to the notice, the models recalled are:

• HVAD™ Pump Outflow Graft: 1125
• HVAD™ Pump Implant Kit: 1103
• HVAD™ Implant Accessories Kit: 1153

There are 5,489 devices on the market, according to the FDA’s recall announcement.

This isn’t Medtronic’s first major recall

In November 2019, the FDA issued another Class I recall for over 160,000 Medtronic catheters, which consumers reported would often break when used and caused severe pain. No fatalities were reported, but the design flaw could have led to serious injuries, prolonged procedures or even deaths.

In October 2012, Medtronic was accused of stealing a design idea for heart-valve patents from their rival company. Not only that, and more pressingly, Medtronic failed to accurately provide the risks to an off-label Infuse bone graft, which tallied over 100 lawsuits and complaints from half a million patients.

Reports highlighted that patients who underwent the surgery suffered from nerve damage, problems breathing or swallowing, paralysis and other chronic debilitating side effects.

Medtronic’s heart pump

Thirty-six complaints were reported at the time of the recall for the HeartWare HVAD system, none of which came from Americans. All the defective heart pumps and batteries were distributed outside of the U.S.

In its safety notice, Medtronic urged healthcare providers to instruct their patients to follow the guidelines within the heart pump’s manual when connecting their device to a power source and pay attention to which USB cable was being plugged in.

“Patients whose devices emit persistent, unexpected audible tones should notify their medical providers.”

Filing a defective product claim

If over 35 years of experience in 12 different states have taught us anything, it’s that filing a claim for a defective product can be confusing and scary. We encourage you to consult with a professional Tennessee attorney who can help you receive compensation and benefits for any pain and financial losses.

Located in Knoxville, Nashville and Memphis, Gilreath & Associates is powered by a committed team of attorneys. Schedule your free initial consultation to find out what we can do to get the compensation you deserve.

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