Ciaglia Blue Tracheostomy Introducer Set Recall: Leaks Could Cause Death

A recall has been announced for certain lots of Cook Medical’s Ciaglia Blue Rhino and Ciaglia Blue Dolphin tracheostomy introducer sets because they could leak and cause serious injury or death. 

The tracheostomy introducer set recall was announced on Wednesday by the FDA after Cook announced that it was pulling the devices from the market because they contain Covidien cuffed Shiley tracheostomy tubes. The cuffs on the tubes have been found to leak air and were the subject of a tracheostomy tube recall originally issued on April 23 after 1,200 reported incidents, including at least three deaths. The deaths all involved Covidien tubes, but it is unclear whether the tubes were being used in Ciaglia tracheostomy introducer sets subject to this recall.

In the affected units, the cuff does not hold air due to leaks in the pilot balloon inflation assembly. This can cause the ventilation system to lose the ability to create positive pressure in the airway, leading to a sudden decrease in the amount of oxygen being received by the patient, or a sudden increase in the amount of carbon dioxide in their blood.

The latest recall affects certain lots of Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays. The recalled sets and trays contain Covidien 6PERC or 8PERC Shiley Tracheostomy Tubes.

Cook Medical informed FDA that it has notified its customers of this issue and they can return recalled products for credit. A notification letter was mailed to customers on April 21, the company said. Any customers with questions or who have devices to return for credit should contact the Cook Medical customer relations department at 1-800-457-4500.