June 7, 2018

FDA issues Class I Recall of CARDIOSAVE Hybrid Intra-aortic Balloon Pump by Maquet Datascope

By: Judy Mathias
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Editor’s Note

The Food & Drug Administration on June 6 identified the recall by Maquet Datascope Corp of its CARDIOSAVE Hybrid Intra-aortic Balloon Pump as Class I, the most serious.

The recall was initiated because of a design issue that allows fluid to seep into the device, which can lead to device malfunction and serious adverse health consequences, including death.

Manufacturing dates were December 12, 2011 to April 25, 2018. Distribution dates were March 6, 2012 to April 26, 2018.

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