Heartware Ventricular Assist Device Recall: Electrical Problems That Could Cause Death
Some of HeartWare’s Ventricular Assist Devices (VADs) are being recalled, due to a problem that may allow water or other material to enter the heart pump, leading to a malfunction of the device that could result in serious injury or death.
The Heartware VAD recall was announced Friday by the FDA, which has determined that the recall receive a Class I classification, meaning that the agency believes the problems with the heart pump problems can result in serious injury or death for patients.
The HeartWare Ventricular Assist Device helps 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.
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The class I recall was issued after reports of contamination to the driveline connector began causing electrical issues, causing the device to malfunction.
The problem stems 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.
Electrical malfunctions or stopping the pump may lead to serious adverse health consequences, including death of the user. Any patient using the VAD for cardiac support is affected by the recall.
The recall is limited to 105 HeartWare Ventricular Assist Devices, also known as an HVAD, sold nationally across the U.S. and manufactured between March 17, 2006, and June 27, 2016. The new HeartWare VAD recall affects devices with serial numbers lower than HW25838 and have product codes 1103 and 1104.
The company initially issued the class I recall July 29 but later issued an Urgent Medical Device Recall Letter to its customers on August 17.
A class I recall is the most serious type of recall that can be issued by the FDA. It is a recall that indicates patients have a high likelihood of being seriously harmed by the recall problem, including causing death.
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.
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