Arrow International Announced The Worldwide Voluntary Recall of Intra Aortic Balloon Pump (IAB) Catheters. Teleflex Medical announced today that the U.S. Food and Drug Administration (FDA) has classified the voluntary medical device recall initiated on February 2, 2009 by Arrow International's Cardiac Care Division involving volume connectors for its 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters as a Class 1 recall. FDA defines Class I recalls as, '' situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.'' This recall has been conducted because a fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 cc or 5 cc, rather than the appropriate 30, 40, or 50 cc volume. In patients exhibiting moderate to severe myocardial ischemia or low perfusion states, prolonged exposure to the low default volume may fail to decrease ischemia and increase perfusion, leading to organ injury or infarct and may result in patient death. Prolonged exposure to a device which is inflated to less than 2/3 full could also result in thrombus formation on the IAB and possible subsequent systemic or cerebral thromboembolism.