A recall initiated by Getinge subsidiaries Datascope and Maquet involving 9,194 units of CS100i, CSO100 and CS300 intra-aortic balloon pumps has been classified by the FDA as Class I. The recall was issued because of the possibility of valve failure that might hamper proper balloon inflation and deflation, posing risks of serious adverse health consequences, potentially including death.
Getinge units' balloon pump recall labeled Class I by FDA
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