AS Myton expressed in the previous post, Maquet/Datascope IABPs were recently recalled for the “False Blood Detection Alarm and Ingress of Fluid into the Intra-Aortic Balloon Pump” [1]. However, this recall only resulted in the recall of the pump mechanism itself, the models CS100i, CS100, and CS300 [2] The intra-aortic balloon itself was not at fault. This recall was justified by the FDA in order to protect potential users. However, by the company separating the manufacturing of the product into two parts, the balloon catheter itself and the pump separately, a recall would not be totally detrimental.
[1] https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm574885.htm
[2]https://www.maquet.com/uk/products/cs100/