Microstream Advance MVIIHRecalls & reported problems
Oridion Medical 1987 Ltd. · Neonatal-Infant Intubated CO2 Filter Line; Extended Duration · Class 2
Data updated Oct 13, 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.
Quick summary
This Oridion Microstream Advance CO2 sampling line monitors carbon dioxide in intubated neonatal and infant patients. Reports mostly describe the unit failing to measure, and staff having trouble disconnecting the adapter from the breathing tube, sometimes causing unplanned extubation. There are 27 reports, no deaths, 8 injuries and 19 malfunctions. One open recall, started February 2025, concerns labeling design and difficulty separating the adapter for procedures such as suctioning. Reports fell from 16 in the earlier 12 months to 2 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 20884521761985), received between May 19, 2023 and Jan 27, 2026 — classified as 8 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Failure to Analyze Signal” (11 reports).
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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Failure to Analyze Signal11
- Difficult or Delayed Separation6
- Mechanical Problem6
- Unable to Obtain Readings5
- Adverse Event Without Identified Device or Use Problem1
- Filtration Problem1
- High Readings1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Unintended Extubation6
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2026Failure to Analyze Signal
IT WAS REPORTED THAT, PRIOR TO USE, THE DEVICE DID NOT MEASURE PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24190559 ↗MalfunctionJan 16, 2026Filtration Problem
IT WAS REPORTED THAT, PRIOR TO USE, THE DEVICE WAS UNABLE TO MEASURE DUE TO A FILTER LINE PROBLEM. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24092593 ↗InjurySep 17, 2025Difficult or Delayed Separation; Difficult or Delayed Separation
IT WAS REPORTED THAT A STAFF MEMBER EXPERIENCED DIFFICULTY DISCONNECTING THE MICROSTREAM FILTER LINE ADAPTER FROM A PATIENT'S ENDOTRACHEAL TUBE AND IN-LINE SUCTION BALLARD, WHICH RESULTED IN AN UNPLANNED EXTUBATION. THE PATIENT, WHO HAD A HISTORY OF TRANSPLANT, WAS NOT RECEIVING AEROSOL TREATMENTS AT THE TIME AND HAD HEATED HUMIDITY THROUGH HEATERS. THE AIRWAY ADAPTER WAS POSITIONED BETWEEN THE VENTILATOR CIRCUIT AND THE IN-LINE SUCTION BALLARD. SHORTLY AFTER THE UNPLANNED EXTUBATION, THE PATIENT REQUIRED REINTUBATION. THE PATIENT EXPERIENCED DESATURATION AND HEART RATE BRADYCARDIA EVENT (DOWN TO 80BPM).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23077432 ↗MalfunctionJul 17, 2025Failure to Analyze Signal; Failure to Analyze Signal
IT WAS REPORTED THAT PRIOR TO USE, THE UNIT HAD NO MEASUREMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22534944 ↗MalfunctionJul 17, 2025Failure to Analyze Signal; Failure to Analyze Signal
IT WAS REPORTED THAT PRIOR TO USE, THE UNIT HAD NO MEASUREMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22534939 ↗MalfunctionJul 17, 2025Failure to Analyze Signal; Failure to Analyze Signal
ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD NO MEASUREMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22534931 ↗MalfunctionJul 17, 2025Failure to Analyze Signal; Failure to Analyze Signal
IT WAS REPORTED THAT PRIOR TO USE, THE UNIT HAD NO MEASUREMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22534928 ↗MalfunctionJul 17, 2025Failure to Analyze Signal; Failure to Analyze Signal
IT WAS REPORTED THAT PRIOR TO USE, THE UNIT HAD NO MEASUREMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22534923 ↗MalfunctionJul 17, 2025Failure to Analyze Signal; Failure to Analyze Signal
IT WAS REPORTED THAT PRIOR TO USE, THE UNIT HAD NO MEASUREMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22534922 ↗MalfunctionJul 17, 2025Failure to Analyze Signal; Failure to Analyze Signal
IT WAS REPORTED THAT PRIOR TO USE, THE UNIT HAD NO MEASUREMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22534839 ↗MalfunctionJul 17, 2025Failure to Analyze Signal; Failure to Analyze Signal
IT WAS REPORTED THAT PRIOR TO USE, THE UNIT HAD NO MEASUREMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22534827 ↗MalfunctionJul 17, 2025Failure to Analyze Signal; Failure to Analyze Signal
IT WAS REPORTED THAT PRIOR TO USE, THE UNIT HAD NO MEASUREMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22534813 ↗MalfunctionJun 9, 2025Failure to Analyze Signal; Failure to Analyze Signal
IT WAS REPORTED THAT PRIOR TO USE, THE UNIT HAD NO MEASUREMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22171009 ↗MalfunctionMay 29, 2025Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT PRIOR TO USE, THE DEVICES DID NOT MEASURE DUE TO FILTER LINE PROBLEMS. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22109060 ↗MalfunctionMay 29, 2025Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT PRIOR TO USE, THE DEVICES DID NOT MEASURE DUE TO FILTER LINE PROBLEMS. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22109054 ↗MalfunctionMay 29, 2025Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT PRIOR TO USE, THE DEVICES DID NOT MEASURE DUE TO FILTER LINE PROBLEMS. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22109047 ↗MalfunctionMay 29, 2025Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT PRIOR TO USE, THE DEVICES DID NOT MEASURE DUE TO FILTER LINE PROBLEMS. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22109044 ↗MalfunctionMay 29, 2025Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT PRIOR TO USE, THE DEVICES DID NOT MEASURE DUE TO FILTER LINE PROBLEMS. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22109041 ↗MalfunctionMay 23, 2024Low Readings; Low Readings
ACCORDING TO THE REPORTER, DURING USE, THE UNIT HAD A DECREASE IN NUMERICAL MEASUREMENT, IT WAS COMING OUT BELOW THE NORMAL RANGE AND IT WAS FALLING COMPARED TO OTHER DEVICES. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 19387880 ↗MalfunctionApr 29, 2024High Readings; Insufficient Device Problem Information; High Readings; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING USE, THE END-TIDAL CARBON DIOXIDE (ETCO2) WAS HIGHER THAN THE PARTIAL PRESSURE OF CARBON DIOXIDE (PACO2) FROM THE VENOUS BLOOD GAS (VBG) DRAW. IT WAS NOTED THAT ALL MODULES WERE CALIBRATED SINCE THE YEARLY SCHEDULED CALIBRATION WAS DUE. THE ETCO2 READINGS WERE CORRECTED PER THE REGISTERED RESPIRATORY THERAPIST (RRT) FOLLOWING THE CALIBRATION. CUSTOMER ADDED THAT AFTER THE MONITORS HAD CO2 RECALIBRATED, THE PACO2 AND ETCO2 NUMBERS LOOKED GOOD. THERE WAS NO ISSUE WITH THE FILTER LINE. THERE WAS NO PATIENT INJURY. NOT A COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19203801 ↗InjuryDec 27, 2023Mechanical Problem; Difficult or Delayed Separation; Mechanical Problem; Difficult or Delayed Separation
ACCORDING TO THE REPORTER, FIVE ¿NEONATAL-INFANT INTUBATED CO2 FILTER LINES¿ WERE UNABLE TO BE DISCONNECTED FROM ENDOTRACHEAL TUBE, WHEN THE NEONATAL PATIENT NEEDED SUCTION. USERS HAD TO REMOVE THE TUBE, PERFORM SUCTION AND RE-INTUBATE AFTERWARDS AGAIN. NO FURTHER COMPLICATION WAS REPORTED.
Patient problems: Unintended Extubation
MAUDE report 18406967 ↗InjuryDec 27, 2023Mechanical Problem; Difficult or Delayed Separation; Mechanical Problem; Difficult or Delayed Separation
ACCORDING TO THE REPORTER, FIVE ¿NEONATAL-INFANT INTUBATED CO2 FILTER LINES¿ WERE UNABLE TO BE DISCONNECTED FROM ENDOTRACHEAL TUBE, WHEN THE NEONATAL PATIENT NEEDED SUCTION. USERS HAD TO REMOVE THE TUBE, PERFORM SUCTION AND RE-INTUBATE AFTERWARDS AGAIN. NO FURTHER COMPLICATION WAS REPORTED.
Patient problems: Unintended Extubation
MAUDE report 18406355 ↗InjuryDec 27, 2023Mechanical Problem; Difficult or Delayed Separation; Mechanical Problem; Difficult or Delayed Separation
ACCORDING TO THE REPORTER, FIVE ¿NEONATAL-INFANT INTUBATED CO2 FILTER LINES¿ WERE UNABLE TO BE DISCONNECTED FROM ENDOTRACHEAL TUBE, WHEN THE NEONATAL PATIENT NEEDED SUCTION. USERS HAD TO REMOVE THE TUBE, PERFORM SUCTION AND RE-INTUBATE AFTERWARDS AGAIN. NO FURTHER COMPLICATION WAS REPORTED.
Patient problems: Unintended Extubation
MAUDE report 18406347 ↗InjuryDec 27, 2023Mechanical Problem; Difficult or Delayed Separation; Mechanical Problem; Difficult or Delayed Separation
ACCORDING TO THE REPORTER, FIVE ¿NEONATAL-INFANT INTUBATED CO2 FILTER LINES¿ WERE UNABLE TO BE DISCONNECTED FROM ENDOTRACHEAL TUBE, WHEN THE NEONATAL PATIENT NEEDED SUCTION. USERS HAD TO REMOVE THE TUBE, PERFORM SUCTION AND RE-INTUBATE AFTERWARDS AGAIN. NO FURTHER COMPLICATION WAS REPORTED.
Patient problems: Unintended Extubation
MAUDE report 18406137 ↗InjurySep 20, 2023Mechanical Problem; Difficult or Delayed Separation; Mechanical Problem; Difficult or Delayed Separation
ACCORDING TO THE REPORTER, ¿NEONATAL-INFANT INTUBATED CO2 FILTER LINES¿ WAS UNABLE TO BE DISCONNECTED FROM ENDOTRACHEAL TUBE WHEN THE NEONATAL PATIENT NEEDED SUCTION. USERS HAD TO REMOVE THE TUBE, PERFORM SUCTION AND RE-INTUBATE AFTERWARDS AGAIN. THE ADAPTOR WAS NOT INITIALLY HARD TO CONNECT ONTO THE ENDOTRACHEAL TUBES. THE ISSUE OF DIFFICULTY REMOVING WAS DEVELOPED OVER TIME. NO FURTHER COMPLICATION WAS REPORTED.
Patient problems: Unintended Extubation
MAUDE report 17785641 ↗
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, ClassifiedMicrostream 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-1380-2025 · Feb 17, 2025 · Open, ClassifiedMicrostream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - OmniVentLine Set Adult-Pediatric CO2 Sampling Line and Airway
- Z-1378-2025 · Feb 17, 2025 · Open, ClassifiedMicrostream 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, ClassifiedMicrostream 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-1381-2025 · Feb 17, 2025 · Open, ClassifiedMicrostream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediatric Intubated, PT00134333 - Microstream Advance Adult-Pediat
- Z-1382-2025 · Feb 17, 2025 · Open, ClassifiedMicrostream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 - Microstream Advance Neonatal-Infant Intub
- Z-1383-2025 · Feb 17, 2025 · Open, ClassifiedMicrostream 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, ClassifiedMicrostream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 - MICROSTREAM FilterLine H Set L
- Z-1376-2025 · Feb 17, 2025 · Open, ClassifiedMicrostream 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-1384-2025 · Feb 17, 2025 · Open, ClassifiedMicrostream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric, PT00156254 - Microstream Advance Adult-Ped
Other ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE devices
- Alaris 8300Carefusion 303, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall2 deaths8,444 reports
- Alaris 8300Carefusion 303, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall607 reports
- BD Alaris™ ETCO2 Module, Model 8300Carefusion 303, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE485 reports
- BD Alaris™ ETCO2 Module, Model 8300Carefusion 303, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE471 reports
- NA GF-210RNihon Kohden Corporation · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE386 reports
- Trilogy IT2110X21BRespironics, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls30 reports
- Trilogy Trilogy Evo Ventilator, GermanyRespironics, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls26 reports
- Trilogy Evo Trilogy Evo Ventilator with oxygen blending model, GermanyRespironics, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls9 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page