Agilis (directing a catheter)

2018: Withdrawal of permission to sale

On January 2, 2018 Management of the USA on control of foodstuff and medicines (FDA) withdrew permission to sale of the regulated directing catheter of Agilis of production of Johnson & Johnson because of the faulty valve.

The regulated directing catheter is intended for introduction and positioning of the used catheter to heart, including in its left half where the device is carried out through a mezhpredserdny partition. The haemo static valve which prevents a reverse current of blood is built in the directing catheter.

The directing Agilis catheter

Noted FDA that the valve can fail because of insufficient isolation of the connector for its fastening. It can lead to penetration of blood via the valve, to a separation of a cap or creation of a difference of pressure because of which air (an air embolism) can get into a vascular bed. FDA was withdrawn by permission to sale of the device under marking of recommendations I of a class which are used regulatory bodies in situations when use of faulty devices can lead to serious injuries or death.

Fault can be connected with insufficient amount of the glue used for repeated attachment of a cap to the connector. However the excess of glue can block the valve and make the device unsuitable for use. The representative of Johnson & Johnson Medical Devices company said that the producer did not receive messages about any adverse phenomena when using the device yet. During the period from January 1, 2017 to May 5, 2017 were made and went on sale of 112 catheters (model number STJ408309, STJ408310, STJG408324).

Johnson & Johnson asks medical institutions and suppliers to return unused devices to the producer and, whenever possible, to distribute information on fault among colleagues.^[1]

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