Teleflex is recalling this 6 mm endotracheal tube in a Class 1 recall. (Image from Teleflex)
Teleflex (NYSE:TFX) is recalling multiple models of its Hudson RCI Sheridan and Sheridan endotracheal tubes due to complaints of the Sheridan connector disconnecting from the breathing circuit. Two deaths and one injury have been reported to the company, according to the FDA.
Each of the more than 6 million recalled tracheal tubes includes an appropriately sized 15mm connector. Although the connector can be removed, it should not disconnect from the endotracheal tube without significant force, the agency said. The FDA has termed it a Class 1 recall, the most serious type of recall involving devices that may cause injury or death.
Teleflex (Wayne, Penn.) has received 179 complaints with 192 occurrences in association with the endotracheal tube disconnection, according to the FDA. In each case of patient death, a decision was made to extubate and reintubate the patient, according to the field notice that Teleflex issued to providers May 27, 2019. The company has began selling the affected tubes in October 2016.
“While initially successful, the patients expired in the presence of subsequent reintubation attempts and other unrelated co-morbidities,” the company’s letter said. “In most reported cases, detachment of the connector was identified by clinical personnel or via eventual decrease in ventilator circuit pressure which triggered ventilator alarms.”
The field notice advises clinical staff to ensure that the 15 mm connector is seated firmly in any of the affected endotracheal tubes already in place to prevent disconnection. Should disconnection occur, the company is advising reconnecting the two components promptly and securely in the manner described in the instructions for use or consider replacing the connector, making sure to evaluate the risks associated with reintubation.
Certain Sheridan-branded EIF-000361 endotracheal tubes and connectors in sizes 6.0, 6.5, 7.0, 7.5, 8.0 and 8.5 mm are included in this recall. Specific lots are:
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- Hudson RCI Sheridan LTS.
- Hudson RCI Sheridan (CF, Preformed, HZT) 6.0, 6.5, 7.0, 7.5, 8.0, 8.5 mm.
- Hudson RCI Sheridan/EZ-ENDO 6.0, 6.5, 7.0, 7.5, 8.0, 8.5 mm.
- Hudson RCI Sheridan Uncuffed 6.0, 6.5, 7.0 mm.
- Sheridan/CF Novaplus 7.0.
- Sheridan/HVT Novaplus 7.0, 7.5, 8.0, 8.5 mm.
A full list of the recalled devices is available here.
Teleflex stock dipped nearly 1% to $330.22 on news of the recall this morning.
This is certainly a worst-case situation, where a failure un-recovered means certain death. It does bring up the question of how was the design approved, and how was the production version verified? Unfortunately we are not given any hint as to the mechanism of the actual failure. Certainly understanding how some failure actually happens can help the rest of us avoid a similar error.