According to a news report published by the United States Food and Drug Administration, Medtronic has issued a new recall of over 23,000 batteries for Medtronic’s HVAD systems. The FDA has just announced another Class I recall that is related to Medtronic’s HeartWare Ventricular Assist Device (HVAD). The recalled devices can lead to severe injuries or fatalities. Medtronic has already stopped all sales and distribution of its HVAD System starting June 3, 2021. However, Medtronic’s left ventricular assist device (LVAD) system is currently inside some patients who are using the devices as a destination therapy or who are waiting to undergo heart transplants.
According to the warning announcement from the FDA, the affected medical devices have been associated with many health issues over the past several years. This Class I recall involves more than 23,000 Medtronic HVAD batteries. The recall was started after Medtronic received complaints that the electrical faults could cause the HVAD batteries to stop working.
According to the FDA’s warning and recall notice, should the battery fail and the patient cannot replace the failed battery or connect to AC or DC power, the HVAD could stop working, causing injury or death. Medtronic states that it has received 1,159 incident reports. Six of those incident reports discussed injuries and one death related to the recalled devices. Customers have been advised to make sure that they have two power sources connected to their controllers and make certain to have fully-charged spare batteries on hand. If it becomes clear that the battery indicator lights aren’t declining over time, that may mean the HVAD battery has an issue. Back in June, Medtronic recalled one batch of more than 400 batteries due to a “welding defect.”
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