The U.S. health regulator on Friday classified the recall of Getinge AB’s heart devices as its most serious type as their use may cause grave injuries or death due to risk of unexpected shutdowns.
The company said it has informed its customers about the issue and there was no material financial impact from the recall.
An estimated 4,502 devices were recalled by the Swedish medical equipment maker’s unit, Datascope, in the country in January, according to the U.S. Food and Drug Administration (FDA).
A communication loss between certain chips may result in an unexpected shutdown of the devices, which are designed to help the heart pump more blood, the agency said….