US FDA classifies recall of heart devices by Getinge as most serious
19 March, 2023, 8:05 am
(Reuters) – The U.S. Food and Drug Administration (FDA) on Friday classified the recall of Getinge AB’s heart devices as the most serious type, saying their use may cause injuries or death.
The Swedish medical equipment maker’s unit, Datascope, recalled an estimated 2,300 devices in the United States in January.
Coiled cable connecting the display and base on some devices of the company may fail, causing an unexpected shutdown, according to the FDA.
The devices are designed to help the heart pump more blood and an unexpected pump shutdown and any interruption to therapy can lead to unstable blood flow, organ damage, including death, especially for people who are critically ill.
Datascope has reported 44 complaints about damaged coiled cords resulting in unexpected shutdowns from June 2019 to August 2022, the FDA said, adding that there have been no reports of injuries or deaths related to this issue.
In January, Datascope had also recalled 4,454 units initiated back in December.
Getinge did not immediately respond to a Reuters request for comment.