The FDA has elevated a recall from Medtronic over neonatal intensive care systems that monitor the airways of intubated newborns, due to sensors that may fail to detect obstructions.
The agency handed down a Class I label for the issue late last week, its most serious designation, that spanned 145 affected Covidien SonarMed monitors and hundreds of its sensor packages across different sizes, all distributed across 19 U.S. states.
The NICU safety systems, which the company first launched in May 2021, rely on acoustic sensors that continuously check for endotracheal tube obstructions by using sound waves and analyzing the echoes.
This allows them to verify the tube’s movement and position in real-time—vital information that previously may have required repeated X-rays.
According to Medtronic, about one in five neonates and infants on ventilators will need that tube to be unexpectedly removed and replaced—a significant percentage, resulting in about 75,000 cases out of the 415,000 that receive mechanical airway support worldwide each year.
SonarMed, with its tech developed at Purdue University, was acquired by Medtronic in December 2020. The FDA said that a software anomaly resulted in the failure to detect some partial obstructions with the system’s 2.5 mm sensor, linked to the device’s design.
Medtronic previously notified healthcare providers with an urgent medical device recall letter March 25, asking them to check serial numbers and discontinue use of the affected systems before returning them to the company. The FDA has not reported any patient injuries related to the issue.