The agency has defined the recall of the Cardiosave Hybrid/Rescue intra-aortic balloon pumps as class 1, the most serious type of recall, meaning use of the device could cause serious injury or death.
Getinge has received 71 complaints related to the recall issue and one reported death.
The intra-aortic balloon pumps are used to treat adults with acute coronary syndrome or heart failure complications.
The recall is the second related to the intra-aortic balloon pumps since Nov. 1, when the company issued a recall of 137 battery packs.
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