Abstract: The adverse events of tracheostomy tube will seriously affect the clinical rescue and treatment. This paper describes product structure and common adverse events, reviews the recall action of imported product and corrective measures of enterprises. This paper also briefly analyzes the possible causes leading to product recalls, advances the measure to reduce the risk of tracheostomy tube, then makes recommendations to the enterprises, health care workers, regulatory authorities, proposes the specific requirements of the product registration documentation. This article intends to provide reference for personnel engaged in production, and technical review, and so on.

Key words: tracheostomy tube, adverse events, recall