The FDA this week labeled Medtronic’s recall of some SonarMed Airway acoustic sensors as Class I, the most serious kind.
Medtronic (NYSE: MDT) initiated the recall of the sensors in March due to a restricted inner diameter of SonarMed Airway resulting in difficulty passing a suction catheter through the sensor.
The company said use of the affected SonarMed Sensors may cause serious adverse health consequences, including treatment delays, low oxygen levels, air leaking into the chest cavity, not enough air reaching the lungs, harm to the tissues, slow heart rate and breathing problems that could lead to respiratory failure.
The recall affects SonarMed Airway acoustic sensors with model numbers AW-S025, AW-S030, AW-S035 and were distributed between October 12, 2022, and August 11, 2023. There are 1,800 devices involved in the recall.
According to the FDA, there have been 1 reported injury and no death reports.
The SonarMed airway monitoring system has a SonarMed monitor that is used in conjunction with a single-patient-use SonarMed Sensor connected through an external cable connection and software that operates the monitor and sensor.
SonarMed AirWave’s airway sensor is placed in-line between the ventilator circuit and the proximal end of the endotracheal tube of a patient with a ventilator. The sensor uses acoustic reflection technology to provide real-time information to clinicians, including baseline location of the ETT tip, estimation of passageway size around the tip, detection of endotracheal tube movement and identification of occlusions or obstructions.
Medtronic’s remediation
Healthcare providers who use the SonarMed airway monitoring system to support the management of artificial airways and people receiving care with the system are most at risk of being affected by this recall.
Medtronic sent an urgent medical device recall notice to customer on March 25, 2024 that recommended healthcare providers discontinue use of the affected sensors and quarantine all SonarMed Airway System products.
