Teleflex this week announced a global recall of affected batches of its Rüsch endotracheal tube products.
The Wayne, Pennsylvania-based company is recalling certain devices due to reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. There is a possibility of oxygen desaturation, and in the event, any immediate or long-term health consequences depend on the degree and duration of desaturation.
Initial investigations have identified that the disconnection results from the intermittent cross-contamination of the 15mm connector with trace amounts of silicone oil. Although this does increase the lubricity of the connection, this does not present additional clinical risks, according to the company.
Where patients are undergoing mechanical ventilation in either the operating room or critical care settings, the ventilation devices to which the affected devices are connected are designed to alarm immediately upon a disconnection in the breathing circuit to alert a clinician to reattach the connector.
Devices in the recall were manufactured between January 2018 and April 24, 2023. The complete list of affected devices is listed below.
Teleflex has received 189 complaints of connector issues for the devices so far. Of the complaints, 11 reported injuries, including nine reports of patient desaturation and four reports of patient death. Three complaints reported that the patient deaths were unrelated to the disconnection of the device, and one reported that it was impossible to determine whether the device contributed to the patient’s death.
The company is recommending clinical staff ensure the 15mm connector is seated firmly in the ET tube to prevent disconnection during use per the product instructions for use. Should a disconnection happen, reconnect the two components promptly and securely as described in the product instructions for use.
