Medtronic Issues Class I Recall for 1,800 SonarMed Airway Acoustic Sensors

May 03, 2024 00:07 CST Updated 00:07

Medtronic

Medical Device Manufacturer

This week, the U.S. Food and Drug Administration recalled some of Medtronic'sSonarMed Airway Acoustic SensorClassified as Level I, which is the most severe category.

Due to the limited inner diameter of the SonarMed airway, which made it difficult for the suction catheter to pass through the sensor, the company initiated a recall of the sensor in March this year.

Medtronic stated that the use of the affected SonarMed sensors may lead to serious adverse health consequences, including treatment delays, low oxygen levels, air leakage into the chest cavity, insufficient air reaching the lungs, tissue damage, slowed heart rate, and breathing problems that could potentially result in respiratory failure.

Recalled Model: AW-S025, AW-S030, and AW-S035 SonarMed Airway Acoustic Sensors;

Recall Time: From October 12, 2022 to August 11, 2023;

Recall Quantity: Involving 1,800 devices;

According to the U.S. Food and Drug Administration, there is currently one person injured, with no reports of death.

# Products from the 2020 acquisition

2020In December, Medtronic announced the acquisition of SonarMed, another significant step for Medtronic in its commitment to improving patient safety and significantly reducing healthcare costs.

SonarMed®, a private medical device company founded in 2005, has been exploring innovative solutions in the medical field with its unique sound technology. Its developed AirWave airway monitoring system provides an effective solution to the key challenges of airway management in intensive care and operating rooms, addressing a significant unmet need.

The AirWave™ system provides continuous, real-time endotracheal tube monitoring for neonatal/pediatric and adult patients. With its unique capabilities, this system is the only FDA-cleared airway monitoring system on the market, specifically designed for patients who are unable to breathe independently.

# UnderstandingSonarMe Airway Monitoring System

SonarMe Airway Monitoring System, as the only ETT airway monitor on the market, has demonstrated its superior performance in the field of critical care.

The system utilizes advanced acoustic reflectometry technology to emit sound waves through the ETT and precisely measure the time and intensity of the sound waves returning to the sensor. The system then analyzes the echo data to accurately determine the current position and integrity of the endotracheal tube (ETT), ensuring that clinicians can quickly obtain critical information.

The SonarMed Airway Monitoring System features real-time visualization capabilities, presenting relevant information directly at the bedside to facilitate troubleshooting. This significantly saves time and reduces the risk of unplanned extubation. The introduction of this innovative technology not only enhances medical efficiency but also helps lower healthcare costs.

This airway monitoring system includes a SonarMed monitor, used together with a single-patient-use SonarMed sensor connected via an external cable, and operates using software to manage both the monitor and sensor.

The airway sensors recalled this time are placed between the ventilator circuit and the proximal end of the endotracheal tube in the ventilator patient. The sensor uses acoustic reflectometry technology to provide clinicians with real-time information, including the baseline position of the ETT tip, an estimate of the channel size around the tip, detection of endotracheal tube movement, and identification of occlusion or blockage.

It is reported that Medtronic issued an urgent medical device recall notice to customers on March 25, 2024, advising healthcare providers to stop using the affected sensors and quarantine all SonarMed airway system products.

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