FDA Classifies Datascope Balloon Pump Recall as Class I

August 14, 2017

The FDA has deemed Datascope and Maquet’s recall of their intra-aortic balloon pumps a Class I recall.

The recall affects nearly 9,200 units, including every lot manufactured prior to June 30, 2013 and distributed between March 24, 2013 and December 11, 2013.

The companies announced the initial recall because of the risk of valve failures, which could hinder the balloons from deflating and inflating properly.

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