Followup to December 2013 Class 1 recall of the HeartWare, Inc. Heartware Ventricular Assist System
In December of last year, the FDA issued its most serious recall, Class 1, for the HeartWare, Inc. “Heartware Ventricular Assist System” pump mechanism. The manufacturer followed up yesterday by reissuing a warning to physicians following additional reports of device failure.
The pump may stop when a component in the connection between pump and controller fails to engage. Without the continual pumping action in patients with weakened hearts and heart failure, reduced or no blood flow could lead to life threatening conditions or death.
Harman Law medical device lawyers are available to consult with patients and families who experience malfunctions or defects in devices that result in injury or death. The firm also works closely with physicians to address their concerns for patient care.
This device is used on patients both in and out of the hospital to help the heart pump blood throughout the body. Some patients have the device while they are waiting for a heart transplant, others may be in heart failure and need the support of the ventricular assist system to help blood move through a damaged part of the heart, most often the lower chamber left ventricle.
The Heartware Ventricular Assist System pump is implanted around the heart and is connected to an external controller. The controller is connected to the pump by a flexible tube that passes through the patients skin. The controller is then powered by batteries or connected to an electrical outlet. When the connector fails, an alarm may sound which can alert the patient or their family to physically reconnect the device to the controller. The concern is that severely impaired patients may not be able to take this action.
Patients who have suffered life threatening conditions, or families of patients who have died while on a pump system, may not be aware if the device was the recalled Heartware Ventricular Assist System. The medical device attorneys at Harman Law are investigating the device failures and filing lawsuits on behalf of injured patients and their families.
HeartWare, Inc. reissued the warning yesterday following eight reports of device failure. The company recommends doctors to inspect the device at the time of implant and at every appointment to make sure the pump connector is secure. The recall is for devices manufactured before November 2013; the company changed their manufacturing process at that time to address the problem.
The product is also called a HVAD (Heartware Ventricular Assist Device).
Harman Law LLC represents clients across the country who have been injured by dangerous and defective drugs and medical devices.
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