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.
