The recall of the sensors, used in conjunction with the SonarMed airway monitoring system, is due to a restricted inner diameter that impedes the passage of suction catheters.

RT’s Three Key Takeaways:

  • The US Food and Drug Administration has identified the recall of the SonarMed airway monitoring system’s sensors as a class I recall, which is the most serious type.
  • The use of the affected SonarMed sensors can lead to serious adverse health consequences, including delays in treatment, low oxygen levels, air leaking into the chest cavity, harm to tissues, slow heart rate, and potentially respiratory failure.
  • Medtronic, on behalf of SonarMed Inc, has advised all affected customers to discontinue use of the sensors and to quarantine all SonarMed airway system products.

Medtronics’ SonarMed Inc is recalling its SonarMed airway acoustic sensors—used with the SonarMed airway monitoring system—due to a restricted inner diameter resulting in difficulty passing a suction catheter through the sensor.

Use of the affected SonarMed sensors may cause serious adverse health consequences, including delays in treatment, low oxygen levels, air leaking into the chest cavity, not enough air reaching the lungs, harm to the tissues, slow heart rate, or breathing problems leading to respiratory failure. 

On March 25, Medtronic, on behalf of SonarMed Inc, sent all affected customers an Urgent Medical Device Recall notice advising them on next steps, including discontinuing use of affected sensors and quarantining all SonarMed airway system products.

There has been one reported injury. No deaths have been reported. The US Food and Drug Administration (FDA) has identified this as a class I recall, the most serious type of recall. 

Device Use 

The SonarMed airway monitoring system consists of a SonarMed monitor used in conjunction with a single-patient-use SonarMed sensor connected via an external cable and software that operates the monitor and sensor.

When in use, 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 who is connected to a ventilator. The Sensor replaces the standard 15-mm connector (also known as the hub) that comes with the ETT and utilizes acoustic reflection technology to provide real-time information to clinicians. This includes the baseline location of the ETT tip, estimation of passageway size around the tip, detection of ETT movement, and identification of occlusions or obstructions.

The SonarMed airway monitoring system is intended for use by trained medical professionals to support the management of artificial airways in hospital settings such as intensive care units, operating rooms, emergency departments, and during intrahospital transport. It is meant to complement standard clinical practices and is not intended as a standalone diagnostic tool. 

The system is suitable for use across a wide range of patients, including neonates, infants, children, adolescents, and adults, covering a size range from 2.5 mm to 9 mm for endotracheal tubes.

Recalled Product 

Who May be Affected  

  • Health care providers who use the SonarMed airway monitoring system to support the management of artificial airways.
  • People who receive care with the SonarMed airway monitoring system. The system is intended for use by trained medical professionals to support the management of artificial airways.

What to Do  

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.

Customers in the US with questions about this recall should contact a Medtronic representative or customer service at 800-962-9888, option 2.

More information can be found on the FDA’s website.

Photo caption: SonarMed airway monitoring system

Photo credit: Medtronic