Recall of Class I Medical Device- Arrow AutoCAT®2 and AC3 Optimus® IABP Series
On 02-Jul-2020, US-FDA released a recall alert for class I medical Device– Arrow AutoCAT®2 and AC3 Optimus® IABP Series due to possible breakdown of motor connector wires. Device Use: The Arrow AutoCAT®2 and AC3 Optimus® are Intra-Aortic Balloon Pumps (IABP) are cardiac assist devices which are used for patients who are undergoing cardiac and non-cardiac…