Ventilator Breathing Circuits Receive the FDA's Most Serious Recall Class After Four Reported Serious Patient Injuries

Federal regulators have applied their most serious recall classification to breathing circuits used with three widely deployed Hamilton Medical ventilators, after a valve defect that a standard pre-use machine check does not detect. The problem has been associated with four serious injuries and no deaths.

The affected products are coaxial breathing circuit sets preassembled with an expiratory valve set, used with the HAMILTON-C1, HAMILTON T-1, and HAMILTON-MR1 ventilators. In some cases, the expiratory valve membrane adheres to the sealing ring on the valve body, impairing valve opening and blocking the flow of exhaled gas out of the circuit.