On September 6, 2017, the Food and Drug Administration announced the immediate recall of over 12,000 intra-aortic balloon pumps manufactured by Datascope Corp./MAQUET due to a product defect that could result in death. The recall affects all such devices manufactured by the company from 2003 to 2017, approximately 5,000 of which were distributed in the United States.
According to the FDA’s announcement, the recall is not requiring the return of the devices to the manufacturer, but rather is giving medical providers additional information regarding a potential “false blood detection alarm” which causes the balloon pump to stop working correctly. In the meantime, Datascope Corp. is contacting healthcare providers and is arranging for technicians to service balloon pumps that are subject to the recall.
An intra-aortic balloon pump is a polyethylene device designed to help the heart work. The device is inserted into a patient’s circulatory system usually through an artery in the leg and is then placed in the aorta. There the balloon inflates and deflates as the heart pumps, increasing the heart’s pumping strength while decreasing the effort required from the heart muscle.
A failure of the “blood detection alarm” causes the balloon pump to cease inflating and deflating. The balloon pump then becomes a risk for blood clot formation within the patient’s aorta, which can be fatal.
Many different kinds of heart patients may undergo procedures involving an intra-aortic balloon pump. These include patients suffering from heart failure, cardiogenic shock, an acute heart attack, or surgical patients undergoing an angioplasty or stent placement.
If you or a loved one would like more information about the link between injuries and intra-aortic balloon pumps, contact a Columbia product liability lawyer at Chappell Smith & Arden, P.A. for experienced help moving forward. Since 1993, our lawyers have been committed to protecting our clients’ rights and interests’ and helping them obtain – and keep – the benefits to which they are entitled. Call us today at 803-929-3600 or contact us online.