The U.S. Food and Drug Administration on Friday issued a recall alert for a Medtronic blood-pumping device called the HeartWare HVAD System, citing a problem that could result in serious health issues or death.
Medtronic voluntarily notified physicians that 16,399 HeartWare HVAD systems implanted in patients as of May 22 could be susceptible to a glitch involving primary and secondary power sources. The glitch could cause confusing beeps and error messages.
On Friday, the U.S. Food and Drug Administration said in a MedWatch report that the issue could lead to serious adverse events, and therefore classified the alert as a Class 1 recall, the highest severity kind.
Devices are not being taken out of patients because of the alert. Rather, Medtronic's letter to doctors emphasized the importance of insuring that two power sources are connected to the system at all times. Also, the company is distributing to doctors a "lubricant solution" that can be used to mitigate the issue.
Ventricular-assist devices like the HeartWare HVAD are among the most complex and costly implantable medical devices sold in the U.S. The HeartWare HVAD is approved for use in patients at risk of dying from end-stage heart failure before they can get a heart transplant. The device is surgically attached to the heart and uses a kind of propeller to circulate a person's blood when their heart isn't strong enough to do the job on its own.
The problem that triggered the alert can happen when there's a brief interruption of power to the device's external controller, causing the device to switch to its secondary power source unexpectedly and potentially causing a momentary stop and restart of the system.
Unintended power switching can also cause the machine to make a beeping sound and to briefly display an incorrect "critical battery alarm" warning.
"There have been no confirmed reports of catastrophic harm associated with this issue. The per patient probability of serious adverse events due to this issue is approximately 0.003," Medtronic said Friday in a statement about the FDA's recall decision. "Patients do not need to take any action other than to follow … recommendations provided by their clinicians."