Sheridan Endotracheal Tube Recall Issued After Four Patient Deaths

Problems with endotracheal tubes made by Teleflex have led to a class I medical device recall, following at least four patient deaths.

The Hudson RCI Sheridan Endotracheal Tube recall was announced by the FDA on June 25, and given the most serious classification, indicating that use of the device poses a risk of serious and life-threatening injury.

The endotracheal tubes are designed to be used orally or nasally for intubation after a patient’s airway has been obstructed, to help the patient breathe properly. When a patient has an endotracheal tube in place, they often rely on the tube to assist with breathing. If the connection fails, the patient may not get adequate oxygen.

The recall was issued after reports were received concerning the 15 mm connector becoming disconnected from the endotracheal tube. This results in disconnection from the breathing circuit, which can lead to a patient receiving insufficient oxygen. A patient who has experienced this problem may need medical intervention.

So far, there have been at least four deaths linked to the recalled endotracheal tubes, as well as other reports involving serious injury where the tube disconnected. In several cases, when the connector failed medical staff attempted to remove the tube (extubate) and reinsert the tube (intubate) to help the patient breathe again. However, in some cases the attempt failed, and the failure resulted in the patient’s death.

In a letter to customers sent out on May 30, Teleflex indicates there have been 192 incidents reported.

The recall involves Sheridan Endotracheal Tubes including tube sizes 6, 6.5, 7, 7.5, 8, and 8.5 mm. The affected Hudson RCI Sheridan Endotracheal Tubes were distributed from October 2016 to May 2019. The letter to customers has a full list of product codes and lot numbers affected by the recall.

The FDA has designated this a Class I recall, meaning the agency believes the problems with the endotracheal tubes can cause serious injuries or death.

Healthcare providers who have the affected product in stock should immediately discontinue use and return it to Teleflex or its distributor, the company warns.

Consumers with questions regarding the recall can contact Teleflex at 866-396-2111. Adverse events or side effects in connection with the product and recall should be reported to the FDA’s MedWatch Adverse Event Reporting Program.