Medtronic Issues Two Recalls Related to Its “HeartWare” Ventricular Assist Device

Medtronic Mechanical Circulatory Support is recalling its HeartWare Ventricular Assist Device (HVAD), a device that helps the heart deliver blood to the rest of the body. Patients with end-state left ventricular heart failure or those waiting for a heart transplant are affected by the recall. The company discovered a loose power connector could cause the rear portion of the pump’s driveline to separate from the front portion. This could allow moisture to cause corrosion and electrical issues, affecting the speaker volume on the device. If the speaker volume is not working, the patient might not be able to hear warning signals coming from the device.

Medtronic is also recalling its “Splice Kit” for the HVAD. Medtronic says it discovered that a design flaw with the repair cable in the Splice Kit made the HVAD vulnerable to shutting down from wear-and-tear forces. If the device shuts down during use, this could cause blood to stop circulating throughout the body.


– Daniel Keum