Microstream Advance MVIIHHRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884521762012), received between Sep 7, 2022 and Feb 20, 2025 — classified as 1 injury, 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-1385-2025 · 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.

• MalfunctionFeb 20, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER PRIOR TO USE, THE LINE FITS TOO TIGHTLY WITH THE NEONATE OR PEDIATRIC DEVICE CLOSED SUCTION SYSTEM REFERENCE CODE 195, CAUSING RESPIRATORY THERAPISTS TO STRUGGLE WHEN TRYING TO REMOVE IT FROM THE SUCTION SYSTEM. IT WAS NOT LOT SPECIFIC. THE CUSTOMER HAD BEEN USING THE SAME DEVICE SAMPLING LINES FOR ABOUT A YEAR, AND THE ISSUE HAD BEEN CONSISTENT. IT WAS DIFFICULT TO REMOVE THE ADAPTER FROM THE ENDOTRACHEAL TUBE (ETT). THE ISSUE DID NOT OCCUR WHEN USING THE OTHER BRAND LINES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21420724 ↗
• InjurySep 7, 2022Filtration Problem; Filtration Problem

  ACCORDING TO THE REPORTER, DURING USE, THE FILTER LINE WAS CLOGGING AFTER FIVE HOURS OF USE. THE INTUBATION WAS FAILED. THE SIDE STREAM DID NOT WORK AND PATIENT WAS INTUBATED WITHOUT IT. THE PROBLEM CONTINUED BUT NOT DUE TO STICKY MEDS. THE NEO SIDE STREAM NEVER PICKED UP ANYTHING. THE MONITOR SHOWED THAT IT WAS CONNECTED AND READY TO USE. HOWEVER, AFTER 10 BREATHS IT JUST WAS NOT PICKING ANYTHING UP. THE MD CONTINUED THE INTUBATION AS THE PATIENT WAS IN FULL CARDIAC ARREST.

  Patient problems: Cardiac Arrest; Unintended Extubation

  MAUDE report 15370247 ↗

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-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-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-1384-2025 · Feb 17, 2025 · Open, Classified
  Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric, PT00156254 - Microstream Advance Adult-Ped
• 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-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-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-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-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-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