SonarMed AirWave AW-S035Recalls & reported problems
Sonarmed, Inc · Neonatal SonarMed Sensor - for use with endotracheal tubes of 3.5 mm ID · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00851334007209), received between Mar 11, 2024 and Mar 11, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Mar 21, 2024Class IOpen, Classified
The failure to detect the partial obstruction in a 2.5mm sensor.
Z-1521-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2024Defective Component; Defective Component
IT WAS REPORTED THAT DURING TESTING, IT WAS ¿EXTREMELY¿ DIFFICULT TO PASS A SUCTION CATHETER THROUGH THIS SONARMED 3.5MM SENSOR. THERE IS A ¿PINCH¿ OF SORTS AT ABOUT THE SECOND MICROPHONE AND THE TIP THAT GOES INTO THE ENDOTRACHEAL TUBE (ETT). THE SENSOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18883077 ↗
Other Airway Monitoring System devices
- SonarMed AirWave AW-M0001Sonarmed, Inc · Airway Monitoring System3 recalls2 reports
- SonarMed AirWave AW-S030Sonarmed, Inc · Airway Monitoring System1 recall3 reports
- SonarMed AirWave AW-S025Sonarmed, Inc · Airway Monitoring System1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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