Microstream AdvanceRecalls & reported problems across all models
Oridion Medical 1987 Ltd. · 13 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Microstream Advance model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 2
We found 13 models of Microstream Advance by Oridion Medical 1987 Ltd. in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Apr 11, 2022 and May 7, 2026 — classified as 9 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Failure to Analyze Signal” (11 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Microstream Advance recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 17, 2025Class IIOpen, 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 · names 3 of these models · Recall details · FDA record ↗
- Feb 17, 2025Class IIOpen, 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 · names 8 of these models · Recall details · FDA record ↗
Most reported Microstream Advance problems
Device problems
- Failure to Analyze Signal11
- Difficult or Delayed Separation8
- Mechanical Problem6
- Unable to Obtain Readings5
- Filtration Problem4
- Low Readings3
- Appropriate Device Problem Term/Code Not Available2
- Device Damaged Prior to Use2
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- Unintended Extubation8
- Insufficient Information2
- Unspecified Tissue Injury2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Cardiac Arrest1
- Foreign Body In Patient1
Microstream Advance models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Microstream Advance MVIIHANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall27 reports
- Microstream Advance MVAIHANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall4 reports
- Microstream Advance MVIIHHANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall2 reports
- Microstream Advance MVAILANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall1 report
- Microstream Advance MVAIHHANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall1 report
- Microstream Advance MVAIANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream Advance MVAI100UANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream Advance MVAIH100UANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream Advance MVAIHLANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream Advance MVIIHLANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream Advance MVASKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream Advance MVABOANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE2 reports
- Microstream Advance MVABO100UANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 report
Recent Microstream Advance adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗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 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 ↗
Other Oridion Medical 1987 Ltd. products
All Oridion Medical 1987 Ltd. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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