Microstream CS08657-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521551503), received between Nov 2, 2017 and Oct 7, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2024Incorrect Measurement; Unable to Obtain Readings; Incorrect Measurement; Unable to Obtain Readings

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD NO READINGS AND ALSO SHOWED INCORRECT RESULTS WHEN INSPECTED BY SPECIALISTS AND TECHNICAL SERVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20383439 ↗
• MalfunctionOct 4, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE DID NOT FUNCTION WELL AND DID NOT GIVE PATIENT APPROPRIATE PARAMETERS. RELEVANT INSPECTIONS BY SPECIALIST AND TECHNICAL SERVICE SHOWED THE DEVICE DID NOT GIVE CORRECT RESULTS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20368629 ↗
• MalfunctionOct 18, 2022Device Alarm System; Noise, Audible; Device Alarm System; Noise, Audible

  ACCORDING TO THE REPORTER, THE DEVICE HAD NO AUDIO EVEN DURING ALARMING. CHECKED ON CONNECTOR TO SEE IF THAT WAS GOOD, BUT WAS DIRECTED WITH AUDIO ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15626296 ↗
• MalfunctionNov 29, 2021Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD HEAT GENERATION IN THE HOUSING AND SMELLED BURNT. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 12882808 ↗
• MalfunctionNov 24, 2020Failure to Analyze Signal; Filtration Problem; Failure to Analyze Signal; Filtration Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A FILTER LINE BLOCKAGE AND NOT ANY NUMERICAL DISPLAYED. THEY REPLACED CONSUMABLES SEVERAL TIMES, BUT THERE WAS NO IMPROVEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10896645 ↗
• MalfunctionNov 2, 2017No Audible Alarm; No Audible Alarm

  MEDTRONIC RECEIVED A REPORT THAT THE UNIT DID NOT GENERATE AN AUDIBLE ALARM. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6997677 ↗