Microstream PM35MN01Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521551589), received between Jul 14, 2023 and Mar 19, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (8 reports).

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.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Failure to Run on Battery; High Readings

  IT WAS REPORTED THAT PRIOR TO USE, THE BATTERY AVAILABILITY FAILED AND THE ETCO2 VALUE WAS HIGHER THAN EXPECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637204 ↗
• MalfunctionMay 27, 2025Low Readings; Low Readings

  IT WAS REPORTED THAT THE DEVICE HAD LOW CO2. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088344 ↗
• MalfunctionJan 16, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT, PRIOR TO USE, THE UNIT HAD A CO2 VALUE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21167401 ↗
• MalfunctionNov 7, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE'S CO2 PARAMETER WAS INCORRECT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630859 ↗
• MalfunctionNov 7, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE PRODUCT HAD INCORRECT CO2 READINGS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20627409 ↗
• MalfunctionNov 6, 2024Incorrect Measurement; Failure to Calibrate; Incorrect Measurement; Failure to Calibrate

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CO2 READING OF THE UNIT WAS NOT ACCURATE, AS THE CO2 CALIBRATION FAILED. NOW SUCCESSFULLY PERFORMED THE CO2 CALIBRATION, HENCE IT SHOWED THE ACCURACY OF CO2. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20624777 ↗
• MalfunctionNov 6, 2024High Readings; High Readings

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD HIGHER ETCO2 THAN EXPECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20623521 ↗
• MalfunctionNov 5, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD LOWER END-TIDAL CARBON DIOXIDE (ETCO2). A SIMULATOR WAS USED TO DETERMINE THE READINGS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20615413 ↗
• MalfunctionOct 7, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, THE DEVICE DISPLAYED INCORRECT CO VALUE COMPARED TO EXPECTED. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20383622 ↗
• MalfunctionAug 27, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, PRIOR TO USE. THE MONITOR SHOWED A LOWER CO2 READING. AND A PUMP TEST WAS REQUESTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20080014 ↗
• MalfunctionJul 18, 2024Erratic or Intermittent Display; Incorrect Measurement; Failure to Calibrate; Erratic or Intermittent Display; Incorrect Measurement; Failure to Calibrate

  ACCORDING TO THE REPORTER, THE UNIT END TIDAL CARBON DIOXIDE (ETCO2) VALUES WERE INCORRECT AND IT HAD CALIBRATION ISSUE. ANOTHER MACHINE WAS USED TO CONFIRM THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19778666 ↗
• MalfunctionMar 25, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE PRODUCT GAVE INCORRECT CO2 READINGS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18973726 ↗
• MalfunctionMar 12, 2024Device Alarm System; Device Alarm System

  ACCORDING TO THE REPORTER, THE ALARM ON THE MONITOR WAS TRIGGERED, BUT THERE WAS NO AUDIO SOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 18889388 ↗
• MalfunctionDec 20, 2023Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, THE UNIT DID NOT GIVE CORRECT PARAMETERS. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18368249 ↗
• MalfunctionJul 14, 2023Device Alarm System; Erratic or Intermittent Display; Display or Visual Feedback Problem; Low Readings; Device Alarm System; Erratic or Intermittent Display; Display or Visual Feedback Problem; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD ABNORMAL ETCO2 READINGS AS LOW READINGS WITH A DISPLAYED READINGS OF 15 - 16 MMHG COMPARED TO TO 33-35 MMHG. READINGS WERE COMPARED WITH ARTERIAL BLOOD GAS (ABG) AND OTHER CO2 MODULE DEVICE. ALSO, LOW ETCO2 READINGS REFERS TO NOT SHOWING READINGS PROPERLY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17330399 ↗