Smiths Medical associates 1 death, 35 injuries to defective airway tubes

Smiths Medical, now part of ICU Medical, has issued a recall for certain Bivona adult and pediatric tracheostomy tubes due to a manufacturing defect that could lead to tearing, displacement, and potentially "catastrophic adverse events." The recall follows reports of one death and 35 serious injuries, according to an Urgent Medical Device Notification recently published by the FDA, which classified the recall as a Class I event, the most severe type.

Smiths Medical has faced several recalls, including those for infusion pumps, ventilators, and syringe pumps. ICU Medical acquired Smiths Medical for $2.35 billion, integrating its devices into its hospital product portfolio. The company has announced cost-cutting measures, including reducing its manufacturing sites and eliminating jobs.

Regarding the tracheostomy tubes, the defect involves a torn or broken flange, which can cause the tube to shift, impacting ventilation or airway protection. Customers have been advised to discard affected products and request replacements or credit.