The Food and Drug Administration (FDA) has announced a recall of specific lots of the Medtronic HeartWare HVAD battery cables, data cables, adapter cables, and controller 2.0 ports due to risk of wear and tear.
The HeartWare Ventricular Assist Device (HVAD) cables and controller ports are part of the HeartWare HVAD System, which is used to help the heart continue to pump blood to the rest of the body. The HVAD system is used as a bridge to cardiac transplants in patients who are at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy (DT) in patients where new transplants are not planned.
Medtronic is recalling the HeartWare HVAD battery cables, data cables, adapter cables, and controller 2.0 ports because of risk of wear and tear of the connector plugs (power sources, data cable, and alarm adapter), which could cause damage to the controller port metal pins (for example, bent pins). Damaged controller ports may prevent power cables and data cables from being connected to the controller and lead to a full or partial stop of the pump, potentially causing serious patient harm, including loss of consciousness, hospitalization, heart attack, or death. On February 26, 2021, Medtronic sent an Urgent Medical Device Notice to all affected U.S. customers.
The FDA has identified this as a Class I recall, the most serious type of recall, as use of the device may result in serious injury or death. There have been 855 complaints, 8 injuries, and 12 deaths reported in relation to this device issue.
Food and Drug Administration (FDA). Medtronic Recalls HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports Due to Risk of Damage to Controller Ports [news release]. April 15, 2021. Available at: click here. Accessed April 16, 2021.