Getinge’s intra-aortic balloon pumps seem to have lost their rhythm: Already this year, the devices have been the target of a handful of FDA Class I recalls in the U.S. and a CE mark suspension in ...
Getinge heart balloon pumps further deflated by 4 more Class I recalls and 6 reported patient deaths
In a flurry of Aug. 31 notices from the FDA, the number of Class I recalls plaguing Getinge’s Cardiosave intra-aortic balloon pumps this year has doubled. The notices detailed four more recalls of the ...
The Food and Drug Administration in a letter Wednesday told healthcare providers and facilities they should stop using certain Getinge cardiovascular medical devices. Getinge has initiated 20 recalls ...
The Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs) have been hit with another recall by the manufacturer (Getinge/Datascope), this time due to damage to the balloon ...
The U.S. Food and Drug Administration (FDA) classified the recall of Getinge's (OTCPK:GNGBF) (OTCPK:GNGBY) heart devices as the agency's Class 1 recall, the most serious type of recall as their use ...
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