Manufacturer has identified an issue related to the neck plate/flange of the device. Specifically, this failure mode can manifest itself during use as a complete or partial detachment of the neck plate from the tracheostomy tube on the device. This failure mode can lead to inadequate ventilation for the patient and complete dislodgement of the tracheostomy tube. Hypoxia, underdose, cardiopulmonary collapse, bradycardia, hypotension, respiratory arrest, or asphyxia can potentially result from the partial or complete detachment of the flange. To date, manufacturer has received five (5) reports of serious injury, and zero (0) deaths potentially related to this issue. Recall start date: July 29, 2024
RecallTracker