Teleflex Stylet, Endotracheal Kit and Flexi-Set

Teleflex has initiated a voluntary field safety corrective action due to reports of pilot balloon non-inflation or cuff non-deflation. In the event of pilot balloon non-inflation, there is a potential risk of injury to the patient as the pilot balloon no longer reflects the condition of the cuff, which may lead to over-inflation of the cuff. The risk persists in situ, therefore clinicians should evaluate the risk benefit to individual patients of extubation and reintubation. In the event of cuff non-deflation, there is the potential risk of injury if the device is removed from the patient with the cuff still inflated. If extubation and removal of the endotracheal tube is planned and the cuff cannot be deflated via the bespak valve, then the inflation line should be cut in order to facilitate passive deflation of the cuff.

Recall start date: December 9, 2022