FDA: Class I recall of Datascope Corp/Maquet intra-aortic balloon pump

Editor's Note

The Food and Drug Administration (FDA) on August 4 classified the recall by Datascope Corp/Maquet (Mahwah, New Jersey) of its intra-aortic balloon pump as Class I, the most serious.

The recall was issued because of the risk of a valve failure, which prevents the balloon from inflating and deflating properly. Device failure may result in immediate and serious adverse health consequences, including death.

The recall is for all lots of model/item numbers CS100i, CSO100, and CS300 manufactured before June 30, 2013.

The FDA has identified this as a Class I recall, the most serious type of recall.