Microstream Advance MVAIHRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884521761916), received between Nov 12, 2024 and Jan 7, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Connection 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Filtration Problem

  IT WAS REPORTED THAT INTRAOPERATIVELY, THE DEVICE WAS REPORTEDLY CLOGGED AND BLOCKED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23993654 ↗
• MalfunctionAug 11, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A PROCEDURE, AN INCIDENT OCCURRED WHERE THE INTUBATION TUBE COULD NOT BE REMOVED FROM A RESPIRATORY PATIENT. AS IT ULTIMATELY DID NOT COME OFF, THE ISSUE WAS RESOLVED BY EXTUBATING AND RE-INTUBATING. IT WAS FURTHER REPORTED THAT THERE WAS NO HARM TO THE PATIENT'S HEALTH, AND THE SITUATION WAS RESOLVED WITHOUT INCIDENT.

  Patient problems: Unintended Extubation

  MAUDE report 22770801 ↗
• MalfunctionJul 7, 2025Contamination /Decontamination Problem; Connection Problem; Material Split, Cut or Torn; Contamination /Decontamination Problem; Connection Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DEVICE CO2 FILTER LINE BROKE DURING PATIENT USE, BECAME DISCONNECTED AT THE LUER CONNECTION, AND EXHIBITED BIO-CONTAMINATION FROM PATIENT USE. ADDITIONALLY, THE DEVICE HEAT SEAL WAS EITHER NOT COMPLETED OR NOT ADEQUATE DURING MANUFACTURING. THE FILTER LINE WAS FOUND DISCONNECTED AT THE LUER END WHILE STILL CONNECTED TO THE VENTILATOR ON THE OTHER END AT THE PATIENT BEDSIDE DURING INTRAOPERATIVE USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22417150 ↗
• MalfunctionNov 12, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD A DECREASE IN NUMERICAL MEASUREMENTS. THE READING WAS BELOW NORMAL RANGE AND IT WAS FAILING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20666590 ↗

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-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-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-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-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-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
• 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-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