Oventus Manufacturing Pty Ltd — O2Vent T Instructions for Use

PRA number


Published date

Product description

The O2Vent T is an oral appliance that is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnoea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions. The O2Vent T is for prescription use only.

Please note there is a separate recall for the O2Vent T Adjuster Assembly (see PRA2017/15794).

Reasons the product is recalled

A correction to the Instructions for Use in relation to the adjustment range for titration is necessary.

The hazards to consumers

Some consumers who are currently being reviewed for optimised treatment may not fully benefit from this product if they don't make the revised adjustment.

What consumers should do

Consumers who are currently be reviewed for optimised treatment should make the following adjustment:

One full turn using the Adjustment Key is 360 degrees. This will adjust the pitch of the screw by 0.5mm resulting in a 0.5mm titration. The screw should be adjusted a maximum of 1mm per night (i.e. 2 full turns of the adjustment key).

Consumers can contact Oventus on 1300 533 159 for further information.


Oventus Manufacturing Pty Ltd

Where the product was sold


Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category