Summary: SonarMed Inc. recalls SonarMed Airway sensors due to restricted inner diameters, impeding suction catheter passage. The FDA classified it as a Class I recall for potentially causing serious health risks. Medtronic issued a recall notice to discontinue use and return affected products.

Key Takeaways:

  • The restricted diameter of SonarMed Airway sensors may result in life-threatening complications like respiratory failure.
  • Medtronic’s recall urges users to discontinue and return affected sensors to prevent serious injuries.

SonarMed Inc. is recalling SonarMed Airway acoustic sensors due to a restricted inner diameter of SonarMed Airway resulting in difficulty passing a suction catheter through the sensor (2.5mm, 3.0mm, and 3.5mm).

Health Risks

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 even breathing problems leading to respiratory failure.

There have been 1 reported injury and no reports of death. The FDA identified it as a Class I recall, the most serious type of recall, meaning that use of these devices may cause serious injuries or death.

Recall Actions

Medtronic, on behalf of SonarMed Inc., sent all affected customers an Urgent Medical Device Recall notice. The letter asked customers to:

  • Discontinue use of affected sensors and quarantine all SonarMed Airway System products.
  • Return all quarantined SonarMed airway sensors to Medtronic.

SonarMed AMS Description

The SonarMed airway monitoring system (AMS) consists of a SonarMed monitor (monitor) that is used in conjunction with a single-patient use SonarMed Sensor (Sensor), connected via an external cable connection, 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.