Cardiovascular medical device developer HeartWare (ASX:HIN) has commenced a voluntary product repair recall for some of its HeartWare controllers which could cost up to $400,000.
The company is conducting in-field repairs and replacements of some of its controllers, because some of them exhibit reduced levels of speaker volume after developing an air vacuum.
The device, which sends power and regulating signals to a heart pump and monitors heart performance, has since been equipped with a vent, but some trial patient of early models may still be exposed. Only one product has so far experienced the defect in the US.
The program is expected to be completed within 30-60 days, HeartWare said.