Arrow International: Arrow AutoCAT 2 and AC3 Optimus intra-aortic balloon pump series
The recall involved 2,123 devices in the U.S. The devices are cardiac assist devices used in patients that are undergoing cardiac and non-cardiac surgery. They are also used to treat patients with acute coronary syndrome or complications from heart failure.
Arrow International issued the recall because both devices have a part (force motor driver) that could break, char and discolor the motor connector wires, which could lead to pump alarms for “System Error 3” and “High Baseline” on the screen of the IABP. The machine could suddenly stop without an alarm and could cause serious patient harm, including organ damage and death.
Arrow International received 30 complaints in total about the device with no injuries or deaths reported, according to a July 2 FDA warning letter.
Balloons involved in the recall were distributed between Mar. 15, 2018 and May 1, 2020.
