The Food and Drug Administration (FDA) on January 25 identified the recall by Datascope/Gettinge of its Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) as Class I, the most serious.
The recall was initiated because of the risk that blood may enter the pump through a damaged balloon catheter.
The pumps are used in cardiac and noncardiac surgery, for acute coronary syndrome, and for complications of heart failure.
There have been 134 complaints and five adverse events related to this issue, including 12 device shutdowns, four serious injuries, and one death.
Distribution dates were March 6, 2012, to present.Read More >>