Medical device manufacturer, Ottobock SE & Co. KGaA, has issued a medical device safety alert concerning its following products:
The PushValve / Mag Valve is a threadless one-way valve, which is used to evacuate air from the prosthetic socket. For valves that have been delivered during the specified period, it has been found that the white valve-insert may fall out under certain conditions.
According to the manufacturer, the cause of the fault is that some of the installed valve-inserts have a diameter outside the tolerance range. As a result, the interference fit assembly may not perform as intended. Since the valve-insert is smaller than the specification, there is play between the valve and the housing, which can lead to the valve falling out of the housing in the event of strong overpressure. If the fault occurs, it can lead to a loosening of the socket and an increased risk for the patient. The failure only concerns the upper part. The Lamination Ring is not affected and can remain in the socket. The manufacturer has not been aware of any case in which the occurrence of the failure has resulted in injury or serious deterioration of a users' health.
Product replacement is on-going.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 Dec 2018