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Medtronic initiates voluntary class I recall of heart device

Medtronic PLC issued a voluntary class I recall of its heart device due to a power source issue.

The Dublin-based medical device company initiated the recall of HeartWare HVAD System after it identified an unexpected power source switching issue, which may cause an interruption to the device's electrical connection.

Medtronic said the recall affected 16,399 Heartware devices implanted as of May 22.

HeartWare HVAD System is a bridge-to-transplantation device, which are used on patients with advanced heart failure who are too sick to wait for a donor heart.

Class I recalls are classified by the U.S. Food and Drug Administration as situations where there are reasonable risks of serious side effects or death.