They say bad things come in threes, and that’s certainly proving to be the case for Medtronic’s long-troubled HeartWare Ventricular Assist Device.
In 2021 alone, the device maker has issued three separate recalls regarding its HVAD system. All three were labeled Class I events, the FDA’s most severe recall classification, indicating an increased risk of serious injury or death.
Ventricular assist devices are implanted in patients with heart failure to help pump blood from one or both ventricles to the rest of the body. They are used as a holdover until a heart transplant can take place as well as as a long-term option for patients ineligible for transplant.
Medtronic’s version is the smallest of these devices to be approved by the FDA. It was originally developed by HeartWare, a cardiac device maker that was acquired by Medtronic for $1.1 billion in 2016—at which time the system had already faced a handful of Class I recalls.
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The latest recall relates to the official manuals and instructions for use that accompany the HVAD system’s pump, controller, surgical tool kits and other components. According to the FDA, 64 injuries and one death have been reported related to the safety issues covered by the recall.
Medtronic will update its instructions and patient manual to provide more information about how to safely clean and wear the device’s carrying case, and details on the lifespan of the carrying case itself. The patient manual will also be updated to ensure patients keep the driveline between the pump and controller covered throughout any controller exchanges, as removing the driveline cover could potentially result in a disconnect between the pump and controller.
Finally, the company will clarify that all of the HVAD system’s LED lights turn red for two and a half seconds during the standard power-up sequence, assuring patients and providers that it does not indicate a “red alarm” battery failure.
The recall affects more than 130,700 devices in the U.S. that have been distributed since early 2006. In a statement to Fierce Medtech, Medtronic said affected patients and healthcare providers were informed of the forthcoming updates to the instructions and manuals in February.
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Earlier this year, in March, the FDA classified another recall of HVAD components as a Class I event. In that case, Medtronic recalled 157 HVAD pump implant kits that were failing to immediately start or restart after the pump had been stopped both during the implantation and pre- and post-implant.
That recall covered devices distributed in the U.S. between October 2017 and April 2020, which the FDA said were related to 19 serious injuries, eight life-threatening events and two deaths.
The following month, the agency issued yet another Class I label to Medtronic’s recall of the HVAD system’s battery, data and adapter cables and controller ports. The FDA linked eight injuries and 12 deaths to instances of partial or full stops of the HVAD pumps caused by wear and tear on the cables and ports.
More than 106,300 devices were affected by those safety issues, with the recall covering HVAD systems manufactured since March 2006.