Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories is a device that includes a catheter, an insertion kit and two STATLOCK IAB stabilization devices. It is a cardiac assist device intended to provide counterpulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle a

An Urgent Medical Device Recall notification letters dated 5/28/19 was sent to the customer. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached URGENT MEDICAL DEVICE RECALL CUSTOMER RESPONSE FORM on page 3, to acknowledge that you have received the Sensation Plus 7.5 Fr. 40cc Intra-Aortic Balloon Catheter with Accessories URGENT MEDICAL DEVICE RECALL. Please fax or email the completed Customer Response Form to 1-585-486-5605.