The U.S. Food and Drug Administration (FDA) has announced an additional recall associated with Medtronic’s HeartWare Ventricular Assist Device (HVAD). This is a Class I recall, which means using the device can lead to serious injury or death.
This latest recall, which follows a series of other incidents related to Medtronic’s HVAD system in recent years, is related to the device’s batteries separating due to a welding defect. One death has been reported due to this issue.
“The welding defect may cause the battery to malfunction and no longer provide power or prevent the battery from holding a full charge or properly recharging,” according to details provided on the FDA’s website. “As a result, the battery may fail suddenly.”
This recall includes a single batch of 429 batteries distributed to customers from April 2021 to July 2021.
Read the full FDA advisory here.
A 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.
“The FDA has monitored the performance of the Medtronic HVAD System since it was approved in 2012, including monitoring neurological adverse event rates,” the agency said at the time. “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.”
In addition, Congress has announced an investigation into how the FDA handled issues with the HVAD system.
“I am concerned by FDA’s slow action, over multiple administrations, to protect patients from this product despite early warning signs,” Rep. Raja Krishnamoorthi said in an open letter detailing these ongoing problems.
Related FDA Recall Content
FDA announces another recall of Medtronic HVAD pump implant kits—1 patient death reported
FDA announces Class I recall of 4,800 imaging catheters due to risk of vascular injury
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.