FDA classifies recall of 2 intra-aortic balloon pumps as Class I, the most serious type of recall
The U.S. Food and Drug Administration has identified the recall of 2 intra-aortic balloon pumps by Arrow International Inc’s as a Class I recall, the most serious type of recall.
Arrow AutoCAT 2 and AC3 Optimus Intra-Aortic Balloon Pump Series were recalled due to possible breakdown of motor connector wires. Recalled devices were manufactured and distributed between August 1, 2014, and May 1, 2020.
The intra-aortic balloon pumps are cardiac assist devices utilized in patients undergoing cardiac and non-cardiac surgery, and to treat patients with acute coronary syndrome or complications from heart failure.
Read the full safety alert from the FDA here.