SonarMed AirWave AW-S030Recalls & reported problems
Sonarmed, Inc · Neonatal SonarMed Sensor - for use with endotracheal tubes of 3.0 mm ID · Class 2
Data updated Oct 16, 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00851334007193), received between Mar 11, 2024 and Mar 11, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Defective Component” (2 reports).
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 16, 2026.
Reports received per month
Recalls naming this device
- Mar 21, 2024Open, Classified
The failure to detect the partial obstruction in a 2.5mm sensor.
Z-1520-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Defective Component2
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2024Defective Component; Defective Component
IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THE CLINICIAN HAD AN ISSUE WITH PASSING A 8FRENCH CATHETER THROUGH THIS 3.0 SONARMED SENSOR. THE CATHETER FIT BUT WAS SO TIGHT AND TOOK SO LONG TO ADVANCE IT OCCLUDED THE ENDOTRACHEAL TUBE (ETT) THAT THE BABY STARTED TO ¿BRADY¿. ALTHOUGH REQUESTED, INFORMATION PERTAINING TO PATIENT INTERVENTION AND OUTCOME HAS NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 18883100 ↗MalfunctionMar 11, 2024Defective Component; Defective Component
IT WAS REPORTED THAT, DURING TESTING, IT WAS ¿EXTREMELY¿ DIFFICULT TO PASS A SUCTION CATHETER THROUGH THIS SONARMED 3.0MM 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 18883083 ↗MalfunctionMar 11, 2024Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT, WHILE IN USE ON A PREMATURE INFANT, THE SONARMED SENSOR MODEL 3.0 HAD ¿PARTIAL OBSTRUCTION AND DID NOT ALLOW SUCTION CATHETER TO PASS EASILY¿. THE SENSOR WAS REPLACED WITH A NEW SENSOR, NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18883046 ↗
Other Airway Monitoring System devices
- SonarMed AirWave AW-M0001Sonarmed, Inc · Airway Monitoring System3 recalls2 reports
- SonarMed AirWave AW-S035Sonarmed, Inc · Airway Monitoring System1 recall1 report
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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