Medtronic HVAD Heart-Assist System Recalled due to Widespread Problem

What should I do?

If you’ve had the Medtronic HeartWare HVAD system implanted, or if you are an end-stage heart failure patient but unsure whether or not you are affected by the recall, you should contact your doctor as soon as possible.

On May 2, 2018, the FDA announced a recall of the Medtronic HeartWare Ventricular Assist Device (HVAD) System. This recall has been designated as a Class I recall, which is the most serious classification of recall by the FDA. Class I recalls are reserved cases where “there is a reasonable probability that the use of [the product] will cause serious adverse health consequences or death.”

The product’s power connections can corrode resulting in temporary power loss. This affects the device regardless of whether it is running on battery, DC or AC power. Corrosion in electrical connections is a very well-understood topic, so this problem should have been foreseeable and preventable.

Although Medtronic is downplaying the severity of the issue in its FDA-mandated notice to providers, the problem rate is estimated at 1 in 4 within two years. Over 13,000 patients have a Medtronic HeartWare HVAD System, so over 3,200 patients are potentially affected.

What exactly is being recalled?

This recall affects Medtronic HVAD systems made and implanted from March 2006 to May 2018. This chart lists the specific models affected. 204,017 devices have been recalled in the US so far.

Recalled Medtronic HeartWare HVAD System Products:

(Table data from Medtronic’s letter advising providers of the potential issues with these devices.)

What is the Medtronic HeartWare HVAD System?

The HVAD System is a pump that helps the heart’s left ventricle deliver blood to the rest of the body. Called an LVAD, it’s used when a patient’s heart is not capable of pumping sufficient blood on its own. The Medtronic HVAD was originally designed to keep patients alive until they could receive a heart transplant. Last year, it was also approved for permanent use in patients who did not qualify for a transplant (or who chose not to have a transplant).

It is used both in and out of hospital settings, including during patient transport. According to Medtronic’s website, the product is used worldwide and serves more than 13,000 patients.

Why was the HVAD System recalled?

The HVAD is being recalled because of the possibility for an interruption in the electrical connection between the system’s power source and the HVAD controller. An interruption to the connection could cause intermittent electrical disconnection, which could result in a pump stop. This can cause harm such as exacerbation of heart failure symptoms, weakness, dizziness, anxiety, nausea, loss of consciousness, or death.

(That’s only for this specific problem. A clinical trial to evaluate the Medtronic HeartWare HVAD found that patients had a higher rate of neurologic injury than the control group in their first 12 months. We hope this is an aberration unique to this study and does not affect other Medtronic patients at higher than normal rates.)

Is Medtronic contacting patients about this?

No. Medtronic is contacting hospitals, doctors and others who use its products. It is up to the hospital, doctor or medical center to contact patients.

What should I do?

If you’ve had the Medtronic HeartWare HVAD system implanted, or if you are an end-stage heart failure patient but unsure whether or not you are affected by the recall, you should contact your doctor as soon as possible.

SUGARMAN has a team of dedicated personal product liability attorneys representing those injured by defective medical products, including products subject to a recall. If you have been hurt by a product defect and wish to speak to one of our attorneys regarding liability, please fill out a Contact Form, call us at (617) 542-1000 or e-mail info@sugarman.com.