FDA elevates Medline recall of endotracheal ventilator tubes

The FDA has elevated a recall from Medline that has seen the device distributor pull tens of thousands of endotracheal tubes from use.

The company’s SubG ventilation tubes deliver oxygen down the throat and into the patient’s lungs and include a separate port for suctioning out and draining any fluids that may accumulate within the airway.

According to the FDA, Medline received reports of certain components detaching or tearing off the main tube during use, resulting in the failure of the inflatable cuff that holds the end of the tube in place and stops leaks to ensure clean airflow.

Without the inflatable cuff, patients could see a drop in the amount of oxygen delivered and the need for the tube to be removed and replaced—as well as the potential for developing ventilator-associated pneumonia from gastric fluids and the harmful buildup of carbon dioxide, the FDA said.

The agency disclosed it has received three reports of injuries, but no deaths, related to the devices—including over 13,000 kits that have been distributed nationwide, containing more than 168,000 tubes. 

The FDA categorized the issue as a Class I recall, its most serious, and recommended that any affected inventory be destroyed. 

Medline first alerted healthcare providers to the problem in late February, before expanding the recall in March, and said that it would issue credits to customers for the impacted equipment.