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.
Unexpected pump shutdown and any interruption to therapy could lead to unstable blood flow, organ damage, including death, especially for critically ill people.
Datascope has reported 42 complaints about the communication failures resulting in unexpected shutdowns of the devices, distributed between March 6, 2012, and Jan. 13 of this year, the FDA said. It added there were no reports of any injuries or deaths related to the issue.
Earlier in March, the FDA had classified recall of an estimated 2,300 of these devices as most serious due to a different issue. Getinge had also recalled 4,454 units initiated back in December due to another issue.