Recall of Intra-aortic Balloons

Recently, the FDA issued a Class 1 recall of some intra-aortic balloons, manufactured by Arrow International. The recalled models include various 30 cc, 40 cc and 50 cc intra-aortic balloons manufactured from January 2008 through January 2009. Such pumps are a component of the Intra-Aortic Pump System which helps increase blood flow to the hearts of critically ill people. The recalled pumps have a faulty connector in their tubing assembly that may result in an incorrect volume setting. Users should return the the recalled products. Class 1 is the most serious type of FDA recall, which is used when there is a reasonable probability that a product will cause serious injury or death. Arrow International is based in Massachusetts.