Arrow Recalls Intra-Aortic Balloon Pumps

Arrow International has recalled (Class 1) its Arrow AutoCAT 2 Intra-Aortic Balloon Pump and AC3 Optimus Intra-Aortic Balloon Pump Series because both devices have a part called the MForce motor driver that may break, char, and discolor the motor connector wires. The wire wear or breakage may lead to pump alarms for “System Error 3” and “High Baseline” to display on the screen of affected devices, a recall notice says. Furthermore, affected devices may suddenly stop, even without an alarm, it says, which may cause serious patient harm including serious organ damage and death. Arrow International says it has received 30 device complaints and there were no injuries or deaths reported with the complaints. The intra-aortic balloon pumps are cardiac assist devices used with patients undergoing cardiac and non-cardiac surgery, and to treat patients with acute coronary syndrome or complications from heart failure.