Possible Defect in HeartWare Device
HeartWare International Inc. warns that its HVAD Pump may have a potential defect and urges doctors to examine the device before use.
The Boston Business Journal (BBJ) reports that the Massachusetts company disclosed that it has received reports of 11 incidents in which a portion of the device becomes partially or completely dislodged. The HVAD Pump is a ventricular assist system, consisting of an implantable centrifugal pump.
Although no patients have been injured, the potential risk of injury has led the company to undertake a voluntary field correction to warn doctors and healthcare professionals to scrutinize the device during regular clinic visits.
The company has warned that "if left unattended, electrical connection to the controller could be affected and a stop alarm could result," according to the BBJ.
Doctors are urged to contact the company to arrange for inspection and repair.