FDA classifies recall of Getinge’s heart devices as most serious

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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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