Federal regulators this week upgraded the recall of Medtronic's HeartWare Ventricular Assist Device to a Class 1 recall, its most serious classification.
Under the recall, the Food and Drug Administration (FDA) warns that "use of these devices may cause serious injuries or death."
Medtronic stopped selling the device, also known as HVAD, last summer as mounting clinical evidence indicated a higher rate of stroke and death among patients using the product compared with similar devices.
