Very recently, Maquet IABPs were recalled from the market due to “false blood detection alarm and ingress of fluid in IABP” [1]. The recall, classified as Class 1, is very serious because IABPs are used as assistive-living devices and may result in serious harm or death. The device’s purpose is to help patients who are undergoing heart surgery and also as an assistive device for individuals with heart failure complications.
In this case, it can be said that both sides are at faults. It can be that Maquet did not perform proper testing and assembly that these products are experiencing some problems. It could also be possible that they hid important but detrimental information from the FDA which then resulted in the recall. On the other hand, the FDA investigators may not have done their job to the best of their ability which resulted in them overlooking important factors in the device.

[1] https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm574885.htm