Teleflex is recalling two lots of a ventilation device after discovering cracks that may enable breathing gas to leak out, leading to insufficient oxygenation.
The recall affects Neonatal ConchaSmart Breathing Circuits, devices used to help infants and neonates breathe by warming and administering gases.
- Teleflex is recalling 300 of the devices from the U.S. months after receiving FDA clearance to sell the product.
Teleflex began the recall after receiving two reports of cracks in an adapter component of the device. The users discovered the cracks before utilizing the devices and there have been no reports of injury or death.
However, there is potential for considerable harm. FDA said 30% of the adapters are expected to exhibit cracks. If the affected devices are used, breathing gas could leak out through the cracks, preventing the neonate or infant from receiving the ventilation support they need. Ultimately, the problem could lead to the patient receiving insufficient oxygen and dying.
Teleflex told customers about the problem via email in May. Users were advised to immediately stop using the devices and quarantine them. This week, FDA followed up with a notice detailing the issue and categorizing the recall as a Class I event.
Cracks are a recurring problem for breathing system heaters, the category that includes Teleflex’s Neonatal ConchaSmart Breathing Circuits. FDA has received 176 reports of cracks about all devices in the category. Almost all of the reports relate to devices sold by Fisher & Paykel Healthcare. Teleflex used a Fisher & Paykel device as the predicate in its 510(k) filing.
The latest regulatory action is the second time in as many months that FDA has categorized a Teleflex recall as a Class I event. The earlier recall saw Teleflex pull six million endotracheal tubes from the U.S. in response to reports that the devices can disconnect from the breathing circuit. Teleflex received 179 complaints associated with disconnections, including reports of two deaths and one injury.
FDA has listed 19 notices related to Teleflex products in its recall database in 2019, although some are repeat alerts related to the same issue. Nine are listed as Class I events. Last year, Teleflex appeared to be the subject of nine FDA recall notices, none of which were categorized as Class I events.
MedTech Dive contacted Teleflex for comment on the recalls but no one was available to respond.