Medtronic stopped the sale of the defective HeartWare Ventricular Assist Device, or HVAD last June after more than 3,000 patients died and 20,000 were injured.
Since 2011, multiple problems with the device have been reported to the Food and Drug Administration but the agency never took any decisive action to make sure the manufacturer fixed the problems. The FDA and its Center for Devices and Radiological Health are in charge of making sure that medical devices are safe and effective for patients however as we highlighted in a previous blog, the agency policy is too accommodating with manufacturers. It has the power to seize products or to issue fines but rarely uses it.
In the case of the HeartWare Ventricular Assist Device, the FDA knew about issues with the product as early as 2011 when the product was developed by the parent company HeartWare and was seeking FDA approval. An inspector mentioned in its report that engineers were not reviewing documents fully before approving them and that the employee assigned to quality control did not have sufficient training. The company told the FDA they would take corrective actions.