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As Reported Death Toll Rises, Medtronic Initiates Another Recall on Heartware Heart Pump

By Burg Simpson
April 16, 2021
2 min read

On April 15, 2021, the FDA announced another recall related to components of the Medtronic HeartWare Ventricular Assist Device (HVAD). The FDA announcement indicates that Medtronic initiated its recall after having learned of 12 deaths linked to the Heartware HVAD systems. The components at issue here are the HVAD Battery Cables, Data Cables, Adapter Cables, and Controller 2.0 Ports. The recall warns that wear and tear may prevent cables from being connected to the HVAD controller. If the cables cannot be connected, the HVAD system may not be able to function, which could prove fatal.

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. The HVAD system relies on its plugs and ports to transmit power and data. However, if wear and tear prevents the connection between cables and ports, power and data transmission may be disrupted and the system may not be able to pump blood throughout the patient’s body. This can lead to serious injury and even death. Indeed, the FDA is aware of at least 855 complaints about this issue which detailed 20 injuries, including 12 deaths.

This is just the latest in a string of recalls related to the Medtronic HVAD system. Previously, in March 2021, the FDA announced that Medtronic was recalling specific lots of its HVAD systems due to potentially defective pump components. In particular, some pumps would fail to start, restart, or experience long delays before restarting. Burg Simpson wrote on that recall here. Additionally, a separate HeartWare HVAD system was recalled in May 2020. This Class 1 recall was related to leaking and device failure.

If you or a loved one suffered injuries you believe were caused by the Medtronic HeartWare Ventricular Assist Device (HVAD) System, the Cincinnati dangerous medical device attorneys at Burg Simpson can help. Burg Simpson has successfully represented thousands of individuals who suffered injuries due to defective products. We know what it takes to hold medical device companies responsible for their actions and secure just compensation for our clients. Call the product liability attorneys in Burg Simpson’s Cincinnati, Ohio office today at 513-852-5600 or fill out our free case evaluation form now to discuss your case with us.

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