Microstream Advance MVAILRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884521761909), received between May 7, 2026 and May 7, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Filtration Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

10 other recalls cover devices cleared under the same FDA submission (K181467); they may or may not involve this specific model.

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-1384-2025 · Root cause: Labeling design · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Low Readings; Filtration Problem

  IT WAS REPORTED THAT DURING CAPNOGRAPHY MONITORING, THE DEVICE SHOWED LOW READINGS DUE TO A FAULTY CO2 SAMPLING LINE. THE PRODUCT WAS NOT TESTED PRIOR TO PATIENT USE, OTHER THAN CONFIRMING AN ETCO2 TRACE ON THE PHILIPS MONITOR. INITIALLY, THE END-TIDAL CO2 TRACE APPEARED NORMAL, BUT IT SUDDENLY RESEMBLED AN OBSTRUCTED AIRWAY, WITH THE WAVEFORM DISTORTED AND THE ETCO2 DECREASING FROM 33 TO 16. THE PATIENT¿S CONDITION DID NOT CHANGE¿TIDAL VOLUME AND OXYGENATION REMAINED STABLE, AND THE ENDOTRACHEAL TUBE WAS CORRECTLY POSITIONED. AFTER REPLACING THE SAMPLING LINE, A NORMAL TRACE AND WAVEFORM WERE OBSERVED, WITH AN ETCO2 VALUE OF 37. WHEN MALFUNCTIONING, THE DEVICE DISPLAYED AN ABNORMAL TRACE CONSISTENT WITH AN OBSTRUCTED AIRWAY PATTERN, WITH VALUES BETWEEN 14 AND 17. ONCE REPLACED WITH A NEW DEVICE, THE ETCO2 TRACE RETURNED TO NORMAL AT 37. IT IS UNKNOWN WHETHER ANY PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 25111197 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181467. One submission often covers many models, so check the product and lot details in each record.

• Z-1722-2025 · Apr 7, 2025 · Open, Classified
  Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Pedi Intub CO2 Line High Humidity
• Z-1381-2025 · Feb 17, 2025 · Open, Classified
  Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediatric Intubated, PT00134333 - Microstream Advance Adult-Pediat
• Z-1385-2025 · Feb 17, 2025 · Open, Classified
  Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Infant, PT00156250 - Microstream Advance Neonatal-Infant In
• Z-1383-2025 · Feb 17, 2025 · Open, Classified
  Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - Microstream Luer Adult-Pediatric
• Z-1380-2025 · Feb 17, 2025 · Open, Classified
  Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - OmniVentLine Set Adult-Pediatric CO2 Sampling Line and Airway
• Z-1377-2025 · Feb 17, 2025 · Open, Classified
  Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 - MICROSTREAM FilterLine H Set L
• Z-1382-2025 · Feb 17, 2025 · Open, Classified
  Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 - Microstream Advance Neonatal-Infant Intub
• Z-1376-2025 · Feb 17, 2025 · Open, Classified
  Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set I
• Z-1378-2025 · Feb 17, 2025 · Open, Classified
  Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 10129497 - CapnoLine Neonatal-Infant
• Z-1379-2025 · Feb 17, 2025 · Open, Classified
  Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampling Line, 01158 - Microstream Luer Adult-Pediatric Airway Ada