Recalled HeartWare Heart Implants Pose Risk of Serious Injury, Death, FDA Warns

Federal regulators are warning about problems with HeartWare Ventricular Assist Device (HVAD), which recently led to two recalls due to the risk of severe injury or death. 

The HeartWare recalls were first issued last month, including one HVAD recall due to electrical problems, and another HVAD controller recall, due to an issue with a loose connector.

This week, the FDA classified both as Class I medical device recalls, which is the most serious recall classification, suggesting that continued use of the HeartWare implants pose a risk of serious adverse events or death.

The HeartWare Ventricular Assist Device (HVAD) is designed to help pump blood from the heart to the rest of the body. It is used in patients who are at risk of death from end-stage left ventricular heart failure. These patients use the pump while waiting for a heart transplant.

The system includes a pump implanted in the space around the heart and a controller regulating the speed and function of the pump. It is designed to be used both in a hospital setting or during patient transport.

Both of the recent recalls involve problems caused by moisture entering the system.

The issues stem from a design issue with the driveline connector. The driveline is a tube that connects the pump to the external controller and power source. Contamination of the driveline may allow fluid or other material to enter the pump and cause electrical problems or cause the pump to stop completely.

The controller recall is similarly linked to a loose connector that could lead to the rear portion of the pump’s driveline connector to become separated from the front part of the connector. If moisture enters the system, it can result in corrosion, electrical issues, cause the speaker volume to be decreased and cause connection failures. A connection failure could cause the pump to stop, and if the speaker volume is reduced, the patient may not hear the device’s alarm, the FDA warns.

Electrical malfunctions or stopping the pump may lead to serious adverse health consequences, including death of the user, the FDA warns.

Heartware’s History of Recalls

HeartWare has a long history of being affected by faulty devices and numerous recalls. The company was involved with another class I recall last year which affected more than 1,700 units across the U.S. During that recall, the Ventricular Assist Systems malfunctioned due to bent pins in a faulty power supply connector port. The company received at least 33 reports of device malfunction, including one non-fatal injury.

Another recall was issued for the HeartWare device in August 2015. The recall was issued after reports of bleeds, blood clot complications, strokes and other injuries were linked to the devices. HeartWare reported they were conducting clinical trials to better evaluate the safety of their devices, yet continue to experience problems.

HeartWare VADs were affected by another recall in 2014. The devices were recalled after a defect caused two deaths and four serious injuries. That recall was also initiated because of a defective driveline connector.

HeartWare was accused of dropping the ball on fixing the issues. Three years prior to the recall, HeartWare received at least 27 complaints about the controller of the pumps.

Users and customers affected by the most recent recall or who have experienced adverse health effects can contact the FDA via the MedWatch Adverse Event Reporting Program online or at 800-FDA-0178.