Intra Aortic Balloon Pump Recall

Arrow International 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters Recalled.

The FDA announced a Class 1 recall for Arrow International 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) catheters, a component of the Intra-Aortic Pump System which is designed to provide cardiac assist therapy to critically ill people to increase blood flow to the heart.

The recall is being conducted because of a fault in the connector of the pump tubing assembly may result in failure of the system to decrease ischemia and increase perfusion, leading to organ injury or infarct and may result in patient death. Prolonged exposure could also result in thrombus formation on the IAB and possible subsequent systemic or cerebral thromboembolism.



http://www.fda.gov/medwatch/safety/2009/safety09.htm#Arrow