Bengaluru: The US Food and Drug Administration on Wednesday classified the recall of Swedish medical equipment maker Getting‘s heart devices as its most serious type since their use could lead to death.
Getting unit datascope recalled 4,454 units in December, following one death and four serious injuries from the use of the therapeutic devices that are designed to help the heart pump moreblood.
The unit has received 134 complaints related to the devices, including unexpected shutdowns, which can cause a burst, leak, or torn balloon leading blood to enter the intra-aortic balloon pump during therapy.
Gettinge did not immediately respond to Reuters’ request for comment outside of business hours.
