The U.S. Food and Drug Administration (FDA) has announced another recall related to Medtronic’s HeartWare Ventricular Assist Device (HVAD). This is a Class I recall, which means using the device in question can lead to serious injury or death.
Medtronic stopped the distribution and sale of the HVAD System as of June 3, 2021. However, the left venticular assist device (LVAD) system is still being used in some patients waiting to undergoing heart transplants, or it is being used as a destination therapy.
The device has been associated with several issues in recent years. This latest recall covers more than 23,000 HVAD batteries. The recall was initiated because electrical faults could cause the batteries to stop working.
“If the battery fails and the patient is unable to replace the failed battery with a charged, working battery or with AC or DC power, the HVAD may stop working, leading to serious injury or death,” according to the FDA’s advisory.
Medtronic has received reports of 1,159 complaints, six injuries and one death related to this issue. Customers have been told to keep two sources of power connected to their controller and keep fully charged spare batteries on hand. If it becomes clear that the battery indicator lights are not decreasing over time, it could be a sign that the battery is experiencing an issue.
In June, the company recalled a single batch of 429 batteries due to what was described at the time as a “welding defect.”
Reviewing the history of issues with the HeartWare Ventricular Assist Device
In March 2021, Medtronic had to recall its HVAD pump implant kits after receiving complaints that the devices “may fail to initially start, restart or have a delay in restarting after the pump was stopped.” There were 29 complaints at the time of that recall, including two deaths and 19 serious injuries. A separate recall for those HVAD pump implant kits was announced in June 2022.
In June 2021, Medtronic stopped the sales and distribution of its HVAD system due to multiple issues, including the ongoing problems with its pump implant kits.
“Although Medtronic has stopped the sale and distribution of new HVAD Systems, the FDA will continue to monitor the safety and effectiveness of the HVAD systems that remain implanted,” the agency said at the time.
In addition, Congress has announced an investigation into how the FDA handled issues with the HVAD system.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.