June 17, 2015 — After dozens of malfunctions and one serious injury, a Class I recall has been issued for the HeartWare Ventricular Assist System (VAS).
The device is a continuous pump that is implanted in patients with end-stage ventricular heart failure. It is also known as a “bridge to transplant” because it helps keep patients alive until they can receive a heart transplant.
Unfortunately, an electrical defect could cause the pump to stop working and result in serious patient injury or death. The problem has been traced to the alignment guides for the power supply connector ports, which can wear out over time and cause the connection to fail between the device and its controller.
The problem has caused at least one serious injury, according to the recall:
“An interruption in this electrical connection would cause the pump to stop, which could cause serious patient injury or death. The company has reported 33 reports of malfunction and one serious injury related to this problem.”
In March, HeartWare recalled about 120 only older-model controllers with product codes 1400 and 1401XX, which were given to patients as part of the ENDURANCE and ADVANCE clinical trials. HeartWare told Medscape they have updated the controllers to better resist electrostatic discharge that could lead to the problem.
In 2014, the company received a warning from the FDA for failing to fix problems after receiving 27 complaints about controller failure within a 3-year period. Two patients died and four others were seriously injured.
Do I have a HeartWare VAS Lawsuit?
The Schmidt Firm, PLLC is currently accepting HeartWare VAS induced injury cases in all 50 states. If you or somebody you know has been injured by a defective heart pump, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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