FDA Issues Communication Regarding Recall of Neonatal & Pediatric Tracheostomy Tubes

A recall has been issued for Medtronic Shiley Neonatal and Pediatric Tracheostomy Tubes.

Tracheostomy patients whose tubes were switched from a previous Shiley tracheostomy tubes to the newer model tubes have experienced airway obstruction, because of the potential differences in the angle of the newer tubes from that of the older tubes.

There have been twelve reports of serious injuries reported to the FDA, but no deaths.

Health care providers and facilities are urged to immediately stop using the tubes and use alternatives instead.


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