Microstream 015328Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884521551982), received between Mar 3, 2020 and Sep 2, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Analyze Signal” (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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 17, 2025Open, Classified

   Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.

   Z-1377-2025 · Root cause: Labeling design · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE NICU DUE TO NEONATAL DISTRESS. THE INFANT WAS PLACED ON INVASIVE VENTILATOR SUPPORT WITH CONTINUOUS MONITORING OF END-TIDAL CARBON DIOXIDE (ETCO2) LEVELS. AT APPROXIMATELY 5:00 PM, ETCO2 READINGS WERE WITHIN NORMAL LIMITS. HOWEVER, DURING A ROUTINE CHECK AT 9:00 PM, THE ATTENDING PHYSICIAN FOUND THAT THE MONITOR NO LONGER DISPLAYED ETCO2 READINGS. RECONNECTION OF THE SAMPLING TUBE DID NOT RESOLVE THE ISSUE. THE SAMPLING TUBE WAS THEN REPLACED WITH A NEW ONE, AFTER WHICH NORMAL ETCO2 MONITORING RESUMED. THE INFANT'S VITAL SIGNS REMAINED STABLE, AND NO ADVERSE OUTCOMES OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937495 ↗
• InjuryMar 3, 2020Failure to Analyze Signal; Filtration Problem; Failure to Analyze Signal; Filtration Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD READING ISSUE AND THE FILTER LINE HAD AN OCCLUSION. THE PATIENT WAS REINTUBATED WITH REPORTS OF MODERATED PAIN AND DISCOMFORT.

  Patient problems: Extubate

  MAUDE report 9781625 ↗