Medtronic Recalls HeartWare (HVAD) Pump Implant Kits for Increased Rate of Failure to Start and Restart Pumping
Following 19 serious complaints of injury, including two deaths, Medtronic initiated a recall of the HeartWare Ventricular Assist Device (HVAD) Pump Implant Kits. The HVAD system is a medical device that is implanted into the body to help the heart pump blood. The HVAD system is often used in patients who have end-stage left ventricular heart failure or patients undergoing heart tissue recovery. During certain medical procedures, the HVAD system’s pumps need to be stopped. When such procedures end, it is crucial that the HVAD system’s pumps restart and continue pumping blood as expected. If they fail to work as intended, it can cause serious harm, including death.
On March 1, 2021, the FDA announced that Medtronic was recalling specific lots of its HVAD systems due to potentially defective pump components. Medtronic observed a higher failure rate (5.2%) in this subset of HVAD systems. In particular, some pumps would fail to start, restart, or experience long delays before restarting. Failure to start or delay of pumps restarting can cause serious injury to patients including myocardial infarctions, worsening heart failure, hospitalizations, or death.
The current affected devices were distributed between October 2017 through April 2020. For patients already implanted with the device, Medtronic is recommending that physicians avoid stopping the pumps when possible. Please read Medtronic’s December 2020 letter for more information about the recall and Medtronic’s recommendations.
A separate HeartWare HVAD system recall was also announced by the FDA on May 28, 2020. This Class 1 recall was related to leaking and device failure. For more information on this recall, click here.
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.