Medtronic Recalls SonarMed Airway Monitors After Injury

Medtronic has issued multiple recalls for its SonarMed airway monitors and acoustic sensors, which are used to monitor patient breathing while on a ventilator and send relevant respiration data to clinicians. The U.S. Food and Drug Administration (FDA) has labeled both recalls as Class I.
 
The first recall concerned a software issue that causes failure to spot a partial obstruction within 2.5 mm sensors and extending up to 3 mm distal to the sensor’s tip. The second recall covers a restricted inner diameter that can cause difficulty passing a suction catheter through the sensor.
 
There’s been one injury reported due to the second issue. However, Medtronic advised that using the affected sensors can cause delays in treatment, low oxygen levels, pneumothorax, hypoventilation, harm to tissues, slow heart rate, or breathing problems.
 
In total, 1,945 sensors were recalled, all of which were distributed between October 2022 and October 2023. There are differences in the dates—acoustic sensors distributed after August 2023 aren’t being recalled.
 
Medtronic advised healthcare professionals and patients to stop using the recalled SonarMed devices immediately, and return quarantined monitors and sensors.

About the SonarMed Airway device

The SonarMed AirWave airway sensor is placed in-line between the ventilator circuit and the proximal end of the endotracheal tube (ETT) of a patient connected to a ventilator. The sensor replaces the standard 15-mm connector that comes with the ETT and uses acoustic reflection technology to provide real-time information to clinicians. This includes the ETT tip’s baseline location, estimation of passageway size around the tip, detection of ETT movement, and identification of occlusions or obstructions.
 
SonarMed supports management of artificial airways in intensive care units, operating rooms, emergency departments, and during intrahospital transport. It’s meant to complement standard clinical practices and isn’t meant to be a standalone diagnostic tool. The system is suitable for use across neonates, infants, children, adolescents, and adults, covering a size range from 2.5mm to 9.0mm for endotracheal tubes.