On May 28, 2020 the U.S. Food and Drug Administration (FDA) issued a Class I recall notice concerning the Medtronic HeartWare Ventricular Assist Device (HVAD) System. A Class I recall is the FDA’s most serious designation and is used only for products that pose a reasonable probability of severe injuries or death.
The Medtronic HVAD devices are implanted into patients with left-sided heart failure to help their heart pump blood to the rest of their body. However, Medtronic recently informed doctors that certain parts of the HVAD System may fail and allow blood to leak out of the device. According to the FDA use of the recalled products may cause serious patient harm including dizziness, loss of consciousness, bleeding, fluid buildup around the heart, additional medical procedures and death. In fact, Medtronic reports that at least four patients have died as a result of these device failures.
If you or a loved one suffered injuries you believe were caused by the Medtronic HeartWare Ventricular Assist Device (HVAD) System, contact one of the experienced medical device attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.