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The U.S. Food and Drug Administration on Wednesday classified the recall of Swedish medical equipment maker Getinge’s heart devices as its most serious type since their use could lead to death.
Getinge unit Datascope recalled 4,454 units in December, following a death and four serious injuries from the use of the therapeutic devices that are designed to help the heart pump more blood.
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.
Getinge did not immediately respond to Reuters’ request for comment outside of business hours.
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