HeartWare Warns of Heart Device Defect
Published: Feb 11, 2013
Medical device firm HeartWare International Inc. (Nasdaq: HTWR) is warning doctors to inspect the company’s HVAD Pump, a ventricular assist system that consists of a small implantable centrifugal blood pump, because of a potential defect. The Framingham, Mass.-based company disclosed in regulatory documents that there have been 11 incidents, out of 2,900 implants, where the rear portion of the HVAD Pump’s driveline connector housing becomes partially or fully separated from the front portion of the drive. There have been no reports of patients being harmed. The company has initiated a voluntary field correction advising healthcare professionals to inspect the driveline connector during routine clinic visits.